<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03816618</url>
  </required_header>
  <id_info>
    <org_study_id>CyberjayaU</org_study_id>
    <nct_id>NCT03816618</nct_id>
  </id_info>
  <brief_title>The Healing Effects Of Honey and Hydrogel Products On The Diabetic Foot</brief_title>
  <official_title>The Healing Effects Of Honey and Hydrogel Products On The Diabetic Foot</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cyberjaya University College of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Diabetic Center-KFSH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cyberjaya University College of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Healing effects of Honey and Hydrogel Products on the Diabetic Foot.&#xD;
&#xD;
      Abstract:&#xD;
&#xD;
      Diabetes mellitus epidemiology is increasing dramatically affecting high numbers of the&#xD;
      world's population, one of the highest risk consequences is diabetic foot and which might&#xD;
      lead to leg amputation causing a permanent disability for the patient.&#xD;
&#xD;
      Several studies had been conducted on the options available to treat diabetic foot ulcer,&#xD;
      Honey products and Hydrogel stands out as an effective topical treatment for the foot&#xD;
      ulceration.&#xD;
&#xD;
      This study discusses the effectivity rate of these products and compares it with the&#xD;
      classical methods followed to treat DF using topical and systematic antibiotics.&#xD;
&#xD;
      Hence; our research raises the following questions:&#xD;
&#xD;
        1. What is the effect of Honey and Hydrogel on the foot anatomy and physiology of DF&#xD;
           patients?&#xD;
&#xD;
        2. Could the investigators introduce a new protocol to treat DF using Honey and Hydrogel&#xD;
           products?&#xD;
&#xD;
      Aiming to achieve the following objects:&#xD;
&#xD;
        1. To provide a new protocol to improve the anatomy and physiology of DF.&#xD;
&#xD;
        2. To compare the efficacy of combined Hydrogel and Honey products on the diabetic foot&#xD;
           ulcer.&#xD;
&#xD;
      Reaching there the investigators are expecting to:&#xD;
&#xD;
        1. To compare the healing time between the patients treated with hydrogel/honey products&#xD;
           and the control treatment patients.&#xD;
&#xD;
        2. To compare Lab parameters improvements between the patients treated with hydrogel/honey&#xD;
           products and the control treatment patients.&#xD;
&#xD;
        3. To compare neurological improvements between the patients treated with hydrogel/honey&#xD;
           products and the control treatment patients.&#xD;
&#xD;
        4. To compare the anatomical improvements between the patients treated with hydrogel/honey&#xD;
           products and the control treatment patients.&#xD;
&#xD;
      In order to provide a clear estimation for the safety and effectivity profile for each&#xD;
      treatment method.&#xD;
&#xD;
      Based on that the investigators are conducting using single blinded randomized clinical trial&#xD;
&#xD;
      Suggesting the following Hypothesis: Treatment using topical MediHoney gel and/or Hydrogel&#xD;
      together separately in association with empiric antibiotic regimens have a higher success&#xD;
      rate comparing with treatment using topical and empiric antibiotic.&#xD;
&#xD;
      A total of 120 DM patients from Outpatients DM type 2 will be included in this study,&#xD;
      following up at diabetic foot center Al-Qaseem Saudi Arabia. Patients will be divided into 4&#xD;
      groups:&#xD;
&#xD;
        1. st group will be treated with topical Medihoney product and empiric antibiotic.&#xD;
&#xD;
        2. nd group will be treated with topical Hydrogel (purloin) gel and empiric antibiotic.&#xD;
&#xD;
        3. rd group will be treated with a combination of Medihoney gel and Hydrogel (purloin) gel&#xD;
           and empiric antibiotic.&#xD;
&#xD;
      The 4th group will be treated with a combination of systematic and topical fucidin 1%&#xD;
      antibiotic this group will be a controlled group.&#xD;
&#xD;
      Based on the expected results the investigators are estimating that this study will raise the&#xD;
      awareness of both health care personnel and the diabetic patients about this condition. It is&#xD;
      expected to provide a clear efficacy estimation for each treatment method followed,&#xD;
      facilitating the choice of treatment for physicians.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Healing Effects of Honey and Hydrogel Products on the Diabetic Foot. Title 1 TITLE OF&#xD;
      RESEARCH PROPOSAL: THE HEALING EFFECTS OF HONEY AND HYDROGEL PRODUCTS ON THE DIABETIC FOOT.&#xD;
&#xD;
      Trial registration 2a Registration by clinical trial. gov, by PRS password available and got&#xD;
      approval Number H-04-Q-001 from National Committee of Bio &amp; Med. Ethics(NCBE).&#xD;
&#xD;
      Protocol version 3 Protocol version helps to mitigate potential confusion over which will be&#xD;
      started after the ethical approval.&#xD;
&#xD;
      Funding 4 The treatment packs will be prepared by diabetic foot centre, materials: natural&#xD;
      drugs, (medihoney gel and purloin gel and fucidine ointment 1%) placebo.&#xD;
&#xD;
      Roles and responsibilities 5a Prof. Dr. Husni Al-Goshae [PHD Neuroscience (UK)], Prof. Dr.&#xD;
      Hamdan Noor [PHD Ox Ford University Physiologist], Consultant Dr. Hamad Saleh Alshubrumi&#xD;
      [Endocrinologist King Fahad Specialist Hospital, Al-Qassim, KSA].&#xD;
&#xD;
      5b Trial Sponsor: Cyberjaya University College of Medical Science Address: Persiaran Bestari&#xD;
      Cyber11, 63000, Cyberjaya, Selangor Malaysia Telephone: 0060383137000 Website:&#xD;
      www.cybermed.edu.mi&#xD;
&#xD;
      5c This funding source had no role in the design of this study and will not have any role&#xD;
      during its execution, analyses, interpretation of the data, or decision to submit results.&#xD;
&#xD;
      5d Design and conduct for preparation of protocol and revisions, investigators brochure and&#xD;
      publication of study reports.&#xD;
&#xD;
      Trial management committee (TMC) Principle [sic] investigator, research physician,&#xD;
      administrator) Study planning , Organization of steering committee meetings Provide annual&#xD;
      risk report MHRA [Medicines and Healthcare Products Regulatory Agency] and ethics committee,&#xD;
      SUSAR [Serious unexpected suspected adverse events] reporting to MHRA and Roche Responsible&#xD;
      for trial master file, Budget administration and contractual issues with individual centers ,&#xD;
      Advice for lead investigators Audit of 6 monthly feedback forms and decide when site visit to&#xD;
      occur.&#xD;
&#xD;
      Assistance with international review, board/independent ethics committee applications; Data&#xD;
      verification Randomization&#xD;
&#xD;
      Introduction Background and rationale 6a Outpatient DM type 2 patients follow up at diabetic&#xD;
      foot center adult more or equal 18 years).&#xD;
&#xD;
      Research question :&#xD;
&#xD;
        1. - What is the effect honey and hydrogel on the foot anatomy and physiology of DF&#xD;
           patients?&#xD;
&#xD;
        2. - Could the investigators introduce a new protocol to treat DF? the investigators find&#xD;
           it very necessary to define the real rate for these two agents treating DF ulcers , to&#xD;
           establish clear clinical evidence supporting the prefer ability of using such natural&#xD;
           low risk and relatively low cost agents in the treatment plan comparing with the use of&#xD;
           the classical antibiotic treatment .&#xD;
&#xD;
      6b &quot;Choice of comparator Effectivity of each product treating DF, the investigators find it&#xD;
      more beneficially to establish a comparative study between such safe and low cost products&#xD;
      and antibiotics recommending a less complicated and safe treatment method using honey and /or&#xD;
      hydrogel rather than depending on the classic antibiotic method with all of its potential&#xD;
      contraindications and restrictions in sensitive group of patients such as DM patients&quot;.&#xD;
&#xD;
      Objectives 7 Research hypothesis Treatment using topical MediHoney gel and/or Hydrogel&#xD;
      together or separately in association with empiric antibiotic regimens have a higher success&#xD;
      rate comparing with treatment using topical and empiric antibiotic.&#xD;
&#xD;
      Study Objectives Main Objectives a) To provide a new protocol to improve to anatomical and&#xD;
      physiological response of DF.&#xD;
&#xD;
      b) To compare the efficacy of combined hydrogel and honey products on DF ulcer.&#xD;
&#xD;
      Specific objectives:&#xD;
&#xD;
        1. To compare the healing time between the patients treated with hydrogel/honey products&#xD;
           and the control treatment patients.&#xD;
&#xD;
        2. To compare Lab parameters improvements between the patients treated with hydrogel/honey&#xD;
           products and the control treatment patient such as CSR and WBC, etc.&#xD;
&#xD;
        3. To compare neurological improvements between the patients treated with hydrogel/honey&#xD;
           products and the control treatment patients.&#xD;
&#xD;
        4. To compare the anatomical improvements between the patients treated with hydrogel/honey&#xD;
           products and the control treatment patients.&#xD;
&#xD;
           8 The study will be conducted using single blinded randomized clinical trial from&#xD;
           October 2018 to February 2021, it will be conducted on DF patients with any stage of&#xD;
           diabetic foot ulcer in the Center of Diabetic Foot, King Fahad specialist hospital&#xD;
           Al-Qassim KSA.&#xD;
&#xD;
           Randomization will be performed as block randomization with a 1:3 allocation.&#xD;
&#xD;
           Methods: Participants, interventions, and outcomes Study setting 9 Outpatients DM type 2&#xD;
           patients, follow up at diabetic foot center. Centre of diabetic foot, King Fahad&#xD;
           Specialist Hospital Al- Qassim KSA.&#xD;
&#xD;
           Eligibility criteria 10 1.1.1. Inclusion Criteria:&#xD;
&#xD;
           It is mandatory for all of the participants to follow each of the following criteria:&#xD;
&#xD;
             -  Adult more or equal 18 years with type 2 DM.&#xD;
&#xD;
             -  Diagnosed with stable DF with any stage of foot ulcer&#xD;
&#xD;
           Exclusion Criteria:&#xD;
&#xD;
           • Patients with unstable severe conditions who requires hospitalization.&#xD;
&#xD;
           • Patients with incomplete data and those who decided to withdraw.&#xD;
&#xD;
             -  Read and understood the consent of the research and didn't approve to participate&#xD;
                accordingly.&#xD;
&#xD;
             -  Patients with open osteomyelitis with discharged us.&#xD;
&#xD;
             -  DM patients with ischemic peripheral PAD gangrene.&#xD;
&#xD;
             -  Charcoat diabetic foot CDF.&#xD;
&#xD;
           Interventions 11a Patients will be divided into 4 groups:&#xD;
&#xD;
           1st group will be treated with topical Medihoney gel product and empiric antibiotic&#xD;
           (systematic) until the result of culture swab wound appears.&#xD;
&#xD;
           2nd group will be treated with topical Hydrogel (purloin) gel and empiric antibiotic&#xD;
           (systematic) until the result of culture swab wound appears.&#xD;
&#xD;
           3rd group will be treated with a combination of topical Medihoney gel and Hydrogel&#xD;
           (purloin) gel and empiric antibiotic (systematic) until the result of culture swab wound&#xD;
           appears.&#xD;
&#xD;
           The 4th group will be treated with a combination of systematic and topical Fucidin&#xD;
           ointment 1% and empiric antibiotics, (systematic) this group will be a controlled group&#xD;
           until the result of culture swab wound appears.&#xD;
&#xD;
           11b Medihoney Gel, Purloin Gel, Fucidin Ointment 1% placebo drug 11c All groups will be&#xD;
           monitored and the prospects for clinical, neurological, and anatomical, improvements&#xD;
           will be followed up by the laboratory.&#xD;
&#xD;
           11d For 3-12 weeks: Close observation and monitoring the topical treatment&#xD;
&#xD;
           Appearance of ischemic arterial disease during participation Contraindication Treatment&#xD;
           DFU(Allergic) As well as termination of participant&#xD;
&#xD;
           Outcomes 12 Main Outcome Measurement:&#xD;
&#xD;
           Ulcer size • Baseline: Size of the Ulcer before the beginning of treatment • Size will&#xD;
           be monitored upon the commencement of the treatment until reaching the healing&#xD;
           condition.&#xD;
&#xD;
           • Main measurement: Time needed to reach the condition of fully healing of the ulcer&#xD;
           (ULCER SIZE IS ZERO) Participant timeline 13 Dressing patient daily. Measurement of&#xD;
           wound every week. This will continue for 3-12 weeks with DF patients. Sample size 14&#xD;
           Sample size calculation&#xD;
&#xD;
           Studies that are analyzed by chi-square or Fisher's exact test calculated sample size&#xD;
           with professor statistical in the CUCMS&#xD;
&#xD;
           Alpha is 5% Estimated power of the study: 80% Ratio of unexposed to exposed 3 (3 groups&#xD;
           of treatment to 1 control group) Expected of unexposed with outcome incidence Expected&#xD;
           exposed with outcome incidence&#xD;
&#xD;
           The sample size formula without the correction factor by Fleiss is:&#xD;
&#xD;
      α: The probability of type I error 5% β: The probability of type II error 20% Zalpha/2=1.96&#xD;
      Zbetta/2=0.842 P0: The proportion of people with control treatment applied in population 1&#xD;
      (0.70) P1: The proportion of people with random treatment applied in population 3 (0.95) r:&#xD;
      The ratio of unexposed to exposed 0.33 NFleiss: Required sample size for the population 1&#xD;
      using Fleiss formula According to the equation N Fleiss should be 30 per group patients.&#xD;
&#xD;
      Recruitment 15 Targeted Sample size:&#xD;
&#xD;
      Our sample size will be 120 patients (due to possibility and cost effectivity) designed as 30&#xD;
      patients in each group.&#xD;
&#xD;
      Methods: Assignment of interventions (for controlled trials)&#xD;
&#xD;
      Allocation: Matching will be done depending on 3 variables:&#xD;
&#xD;
        -  Gender:&#xD;
&#xD;
        -  Age:&#xD;
&#xD;
        -  Dounis classification:&#xD;
&#xD;
      Type I Type II Type III (A,B,C)&#xD;
&#xD;
      Sequence generation 16a Participants will be randomly assigned to either control or&#xD;
      experimental group with a 1:3 allocation&#xD;
&#xD;
      Type of randomization: single, blind randomization convenient for all patients follow up in&#xD;
      the DF center, with matching factors; age, gender, Dounis anatomical classification.&#xD;
&#xD;
      Allocation concealment mechanism 16b Participants will randomised using central randomisation&#xD;
      service. Allocation concealment will be ensured, as the service will not release the&#xD;
      randomization code until the patient has been recruited into the trial, which takes place&#xD;
      after all baseline measurements have been completed.&#xD;
&#xD;
      Implementation 16c All patients who give consent for participation and who fulfil the&#xD;
      inclusion criteria will be randomized. Randomization will be requested by the staff member&#xD;
      responsible for recruitment and clinical interviews from CenTrial [Coordination Centre of&#xD;
      Clinical Trials]. In return, CenTrial will send an answer form to the study therapist who is&#xD;
      not involved in assessing outcome of the study. This form will include a randomization&#xD;
      number. In every center closed envelopes with printed randomization numbers on it are&#xD;
      available. For every randomization number the corresponding code for the therapy group of the&#xD;
      randomization list will be found inside the envelopes. The therapist will open the envelope&#xD;
      and will find the treatment condition to be conducted in this patient. The therapist the&#xD;
      gives the information about treatment allocation to the patient. Staff responsible for&#xD;
      recruitment and symptom ratings is not allowed to receive information about the group&#xD;
      allocation.&#xD;
&#xD;
      Blinding (masking) 17a Due to the nature of the intervention, participants can be blinded to&#xD;
      allocation but are strongly inculcated not to disclose the allocation status of the&#xD;
      participant at the follow up assessments. An employee outside the research team will feed&#xD;
      data into the computer in separate datasheets so that the researchers can analyze data&#xD;
      without having access to information about the allocation.&#xD;
&#xD;
      17b If un-blinding is deemed to be necessary, the investigator should use the system for&#xD;
      emergency un-blinding through the local emergency number as the back-up system.&#xD;
&#xD;
      Methods: Data collection, management, and analysis Data collection methods 18a Plans for&#xD;
      assessment and collection of outcome, baseline, and other trial data, including any related&#xD;
      processes to promote data quality (eg, duplicate measurements, training of assessors) and a&#xD;
      description of study instruments (eg, questionnaires, laboratory tests) along with their&#xD;
      reliability and validity, if known. Reference to where data collection forms can be found, if&#xD;
      not in the protocol&#xD;
&#xD;
      Main Outcome Measurement:&#xD;
&#xD;
      Ulcer size • Baseline: Size of the Ulcer at the before the beginning of treatment&#xD;
&#xD;
      • Size will be monitored upon the commencement of the treatment until reaching the healing&#xD;
      condition.&#xD;
&#xD;
      • Main measurement: Time needed to reach the condition of fully heal of the ulcer (ULCER SIZE&#xD;
      IS ZERO) Quality Control of the Core Lab Data from the Core Lab will be securely transmitted&#xD;
      in batches and quality controlled in the same manner as Core Coordinating Center Data.&#xD;
&#xD;
      18b Provide written feedback to all patients about the results of the health screening.&#xD;
      Maintain interest in the study through materials and mailing. Send letters to patients prior&#xD;
      to the final data collection, reminding them of the upcoming data collection.&#xD;
&#xD;
      Participants may withdraw from the study for any reason at any time. The investigator also&#xD;
      may withdraw participants from the study in order to protect their safety and/or if they are&#xD;
      unwilling or unable to comply with required study procedures after consultation with the&#xD;
      protocol chair.&#xD;
&#xD;
      Data management 19 Participant files are to be stored in numerical order and stored in a&#xD;
      secure and accessible place and manner. Participant files will be maintained in storage for a&#xD;
      period of 3 years after completion of the study.&#xD;
&#xD;
      Weekly reports with information on missing data, missing forms, and missing visits. Personnel&#xD;
      at the Core Coordinating Center and the Participating Sites should review these reports for&#xD;
      accuracy and report any discrepancies to the investigator.&#xD;
&#xD;
      Statistical methods 20a Statistical methods for analyzing primary and secondary outcomes.&#xD;
      Reference to where other details of the statistical analysis plan can be found, if not in the&#xD;
      protocol&#xD;
&#xD;
      Analysis methods will depend on the improvements according to Dounis classification, as well&#xD;
      as each of the clinical, neurological, anatomical, and angiographic improvement rate.&#xD;
&#xD;
      20b Methods for any additional analyses (eg, subgroup and adjusted analyses)&#xD;
&#xD;
      The data will be analyzed using version 23 of SPSS statistical software (SPSS Inc., Chicago,&#xD;
      IL, USA). Descriptive statistics will be calculated as proportions or as means (with standard&#xD;
      deviations) as appropriate. The significance level will be set as p value&lt;0.05.&#xD;
&#xD;
      20c The investigators propose declaring medical management non-inferior to interventional&#xD;
      therapy, only if shown to be non-inferior using both the &quot;intention to treat&quot; and &quot;per&#xD;
      protocol&quot; analysis sets.&#xD;
&#xD;
      Methods: Monitoring Data monitoring 21a The DMC is independent of the study organizers.&#xD;
      During the period of recruitment to the study, interim analyses will be supplied, in strict&#xD;
      confidence, to the DMC, together with any other analyses that the committee may request. This&#xD;
      may include analyses of data from other comparable trials.&#xD;
&#xD;
      21b An interim-analysis is performed on the primary endpoint when 50% of patients have been&#xD;
      randomized and have completed the 6 months follow-up.&#xD;
&#xD;
      Harms 22 Adverse events will be collected after the subject has provided consent and enrolled&#xD;
      in the study. If a subject experiences an adverse event after the informed consent document&#xD;
      is signed (entry) but the subject has not started to receive study intervention.&#xD;
&#xD;
      Auditing 23 The quality and completeness of the data will be reflective of the state of the&#xD;
      art in clinical trials. The focus of the visit/electronic monitoring will be on source&#xD;
      document review and confirmation of adverse events. The monitor will verify the following&#xD;
      variables for all patients: initials, date of birth, sex, signed informed consent,&#xD;
      eligibility criteria, date of randomization, treatment assignment, adverse events, and&#xD;
      endpoints.&#xD;
&#xD;
      Ethics and dissemination Research ethics approval 24 The protocol, site-specific informed&#xD;
      consent forms (local language and English versions), participant education and recruitment&#xD;
      materials, and other requested documents-and any subsequent modifications - also will be&#xD;
      reviewed and approved by the ethical review bodies.&#xD;
&#xD;
      The Investigator will make safety and progress reports and summaries review of safety and/or&#xD;
      efficacy.&#xD;
&#xD;
      Protocol amendments 25 Any modifications to the protocol which may impact on the conduct of&#xD;
      the study, potential benefit of the patient or may affect patient safety, including changes&#xD;
      of study objectives, study design, patient population, sample sizes, study procedures, or&#xD;
      significant administrative aspects will require a formal amendment to the protocol.&#xD;
&#xD;
      Consent or assent 26a Trained Research Nurses will introduce the trial to patients who will&#xD;
      receive information sheets. Research Nurses will discuss the trial with patients in light of&#xD;
      the information provided in the information sheets. Patients will then be able to have an&#xD;
      informed discussion with the participating consultant. Research Nurses will obtain written&#xD;
      consent from patients willing to participate in the trial. Information sheets and consent&#xD;
      forms are provided for all parents involved in the trial&#xD;
&#xD;
      26b A materials consent will be obtained to specifically address the collection&#xD;
&#xD;
      Confidentiality 27 All study-related information will be stored securely at the study site.&#xD;
      All participant information will be stored in locked file cabinets in areas with limited&#xD;
      access. All laboratory specimens, reports, data collection, process, and administrative forms&#xD;
      will be identified by a coded ID [identification] number only to maintain participant&#xD;
      confidentiality. All records that contain names or other personal identifiers, such as&#xD;
      locator forms and informed consent forms, will be stored separately from study records&#xD;
      identified by code number. All local databases will be secured with password-protected access&#xD;
      systems. Forms, lists, logbooks, appointment books, and any other listings that link&#xD;
      participant ID numbers to other identifying information will be stored in a separate, locked&#xD;
      file in an area with limited access.&#xD;
&#xD;
      Declaration of interests 28 He does not have any paid consultancies with pharmaceutical&#xD;
      companies, and is not a member of the Speaker's Panel of any company.&#xD;
&#xD;
      Access to data 29 All Principal Investigators will be given access to the cleaned data sets.&#xD;
      Project data sets will be housed on the Project Accept Web site and/or the file transfer&#xD;
      protocol site created for the study, and all data sets will be password protected. Project&#xD;
      Principal Investigators will have direct access to their own site's data sets, and will have&#xD;
      access to other sites data by request. To ensure confidentiality, data dispersed to project&#xD;
      team members will be blinded of any identifying participant information&#xD;
&#xD;
      Ancillary and post-trial care 30 The liability of the manufacturer is strictly limited to&#xD;
      those claims arising from faulty manufacturing of the commercial product and not to any&#xD;
      aspects of the conduct of the study.&#xD;
&#xD;
      Dissemination policy 31a The Publications subcommittee will review all publications following&#xD;
      the guidelines and report its recommendations to the Steering Committee.&#xD;
&#xD;
      the scientific integrity of the project requires that the data from all BEST Evaluation of&#xD;
      Survival Trial sites be analyzed study-wide and reported Each paper must be submitted to the&#xD;
      appropriate Subcommittee for review of its appropriateness and scientific merit prior to&#xD;
      submission.&#xD;
&#xD;
      31b There are three classes of reports;&#xD;
&#xD;
      a) Reports of the major outcomes of the study. b) Reports addressing in detail one aspect. c)&#xD;
      Reports of data derived from a subset of centers.&#xD;
&#xD;
      31c Data sharing statement No later than 3 years after the collection of the 2-year post&#xD;
      randomization interviews, The investigators will deliver a completely de-identified data set&#xD;
      to an appropriate data archive for sharing purposes Appendices Informed consent materials 32&#xD;
      Study number: Not available Investigator Name: Dr. Wael Searan Address: Center Endocrinology&#xD;
      and Diabetes, Buraidah, Al-Qassim, KSA. Consent Form: This consent form is part of the&#xD;
      informed consent process. It is designed to give you an idea of what this research study is&#xD;
      about and what will happen to you if you choose to be in the study…&#xD;
&#xD;
      Biological specimens 30&#xD;
&#xD;
      In my study measurement there is no any biological specimens.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Actual">February 13, 2023</completion_date>
  <primary_completion_date type="Actual">February 1, 2023</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>PROSPECTIVE</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ulcer size</measure>
    <time_frame>FROM 3 WEEKS UP TO 12 WEEKS</time_frame>
    <description>ULCER SIZE</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Diabetic Foot</condition>
  <arm_group>
    <arm_group_label>CONTROL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CONTROL GROUP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TREATMENT1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TREATMENT GROUP 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TREATMENT2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TREATMENT GROUP 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TREATMENT3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TREATMENT GROUP 3</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Medihoney Gel in A Tube</intervention_name>
    <description>TREATMENT1</description>
    <arm_group_label>TREATMENT1</arm_group_label>
    <arm_group_label>TREATMENT3</arm_group_label>
    <other_name>MEDIHONEY</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydrogel</intervention_name>
    <description>PURLOIN GEL</description>
    <arm_group_label>TREATMENT2</arm_group_label>
    <arm_group_label>TREATMENT3</arm_group_label>
    <other_name>PURLOIN</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fucidin Ointment</intervention_name>
    <description>FUCIDIN ANTIBIOTIC OINTMENT 10%</description>
    <arm_group_label>CONTROL</arm_group_label>
    <other_name>FUCIDIN OINTMENT 10%</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult more or equal 18 years with type 2 DM.&#xD;
&#xD;
          -  Diagnosed with stable DF with any stage of foot ulcer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with unstable severe conditions who requires hospitalization.&#xD;
&#xD;
          -  Patients with incomplete data and those who decided to withdraw.&#xD;
&#xD;
          -  Read and understood the consent of the research and didn't approve to participate&#xD;
             accordingly.&#xD;
&#xD;
          -  Patients with open osteomyelitis with discharged us.&#xD;
&#xD;
          -  DM patients with ischemic peripheral PAD gangrene.&#xD;
&#xD;
          -  Charcoat diabetic foot CDF.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Diabetic Center-KFSH</name>
      <address>
        <city>Buraidah</city>
        <state>Al-Qassim</state>
        <zip>51411</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetes Center, Center Diabetic Foot, King Fahd Specialist Hospital, Ministry Of Health Buraydah; Al Qassim; Saudi Arabia</name>
      <address>
        <city>Buraidah</city>
        <state>Elqassim</state>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>February 16, 2023</last_update_submitted>
  <last_update_submitted_qc>February 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>purilon gel</keyword>
  <keyword>medihoney</keyword>
  <keyword>fucidine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Foot</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fusidic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>https://www.nice.org.uk/guidance/CG10</doc_url>
      <doc_comment>National Institute for Health and Clinical Excellence. Type 2 diabetes; prevention and management of foot problems</doc_comment>
    </study_doc>
  </study_docs>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03816618
org study id: CyberjayaU
nct id: NCT03816618
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The Healing effects of Honey and Hydrogel Products on the Diabetic Foot.

      Abstract:

      Diabetes mellitus epidemiology is increasing dramatically affecting high numbers of the
      world's population, one of the highest risk consequences is diabetic foot and which might
      lead to leg amputation causing a permanent disability for the patient.

      Several studies had been conducted on the options available to treat diabetic foot ulcer,
      Honey products and Hydrogel stands out as an effective topical treatment for the foot
      ulceration.

      This study discusses the effectivity rate of these products and compares it with the
      classical methods followed to treat DF using topical and systematic antibiotics.

      Hence; our research raises the following questions:

        1. What is the effect of Honey and Hydrogel on the foot anatomy and physiology of DF
           patients?

        2. Could the investigators introduce a new protocol to treat DF using Honey and Hydrogel
           products?

      Aiming to achieve the following objects:

        1. To provide a new protocol to improve the anatomy and physiology of DF.

        2. To compare the efficacy of combined Hydrogel and Honey products on the diabetic foot
           ulcer.

      Reaching there the investigators are expecting to:

        1. To compare the healing time between the patients treated with hydrogel/honey products
           and the control treatment patients.

        2. To compare Lab parameters improvements between the patients treated with hydrogel/honey
           products and the control treatment patients.

        3. To compare neurological improvements between the patients treated with hydrogel/honey
           products and the control treatment patients.

        4. To compare the anatomical improvements between the patients treated with hydrogel/honey
           products and the control treatment patients.

      In order to provide a clear estimation for the safety and effectivity profile for each
      treatment method.

      Based on that the investigators are conducting using single blinded randomized clinical trial

      Suggesting the following Hypothesis: Treatment using topical MediHoney gel and/or Hydrogel
      together separately in association with empiric antibiotic regimens have a higher success
      rate comparing with treatment using topical and empiric antibiotic.

      A total of 120 DM patients from Outpatients DM type 2 will be included in this study,
      following up at diabetic foot center Al-Qaseem Saudi Arabia. Patients will be divided into 4
      groups:

        1. st group will be treated with topical Medihoney product and empiric antibiotic.

        2. nd group will be treated with topical Hydrogel (purloin) gel and empiric antibiotic.

        3. rd group will be treated with a combination of Medihoney gel and Hydrogel (purloin) gel
           and empiric antibiotic.

      The 4th group will be treated with a combination of systematic and topical fucidin 1%
      antibiotic this group will be a controlled group.

      Based on the expected results the investigators are estimating that this study will raise the
      awareness of both health care personnel and the diabetic patients about this condition. It is
      expected to provide a clear efficacy estimation for each treatment method followed,
      facilitating the choice of treatment for physicians.
The Healing Effects of Honey and Hydrogel Products on the Diabetic Foot. Title 1 TITLE OF
      RESEARCH PROPOSAL: THE HEALING EFFECTS OF HONEY AND HYDROGEL PRODUCTS ON THE DIABETIC FOOT.

      Trial registration 2a Registration by clinical trial. gov, by PRS password available and got
      approval Number H-04-Q-001 from National Committee of Bio & Med. Ethics(NCBE).

      Protocol version 3 Protocol version helps to mitigate potential confusion over which will be
      started after the ethical approval.

      Funding 4 The treatment packs will be prepared by diabetic foot centre, materials: natural
      drugs, (medihoney gel and purloin gel and fucidine ointment 1%) placebo.

      Roles and responsibilities 5a Prof. Dr. Husni Al-Goshae [PHD Neuroscience (UK)], Prof. Dr.
      Hamdan Noor [PHD Ox Ford University Physiologist], Consultant Dr. Hamad Saleh Alshubrumi
      [Endocrinologist King Fahad Specialist Hospital, Al-Qassim, KSA].

      5b Trial Sponsor: Cyberjaya University College of Medical Science Address: Persiaran Bestari
      Cyber11, 63000, Cyberjaya, Selangor Malaysia Telephone: 0060383137000 Website:
      www.cybermed.edu.mi

      5c This funding source had no role in the design of this study and will not have any role
      during its execution, analyses, interpretation of the data, or decision to submit results.

      5d Design and conduct for preparation of protocol and revisions, investigators brochure and
      publication of study reports.

      Trial management committee (TMC) Principle [sic] investigator, research physician,
      administrator) Study planning , Organization of steering committee meetings Provide annual
      risk report MHRA [Medicines and Healthcare Products Regulatory Agency] and ethics committee,
      SUSAR [Serious unexpected suspected adverse events] reporting to MHRA and Roche Responsible
      for trial master file, Budget administration and contractual issues with individual centers ,
      Advice for lead investigators Audit of 6 monthly feedback forms and decide when site visit to
      occur.

      Assistance with international review, board/independent ethics committee applications; Data
      verification Randomization

      Introduction Background and rationale 6a Outpatient DM type 2 patients follow up at diabetic
      foot center adult more or equal 18 years).

      Research question :

        1. - What is the effect honey and hydrogel on the foot anatomy and physiology of DF
           patients?

        2. - Could the investigators introduce a new protocol to treat DF? the investigators find
           it very necessary to define the real rate for these two agents treating DF ulcers , to
           establish clear clinical evidence supporting the prefer ability of using such natural
           low risk and relatively low cost agents in the treatment plan comparing with the use of
           the classical antibiotic treatment .

      6b "Choice of comparator Effectivity of each product treating DF, the investigators find it
      more beneficially to establish a comparative study between such safe and low cost products
      and antibiotics recommending a less complicated and safe treatment method using honey and /or
      hydrogel rather than depending on the classic antibiotic method with all of its potential
      contraindications and restrictions in sensitive group of patients such as DM patients".

      Objectives 7 Research hypothesis Treatment using topical MediHoney gel and/or Hydrogel
      together or separately in association with empiric antibiotic regimens have a higher success
      rate comparing with treatment using topical and empiric antibiotic.

      Study Objectives Main Objectives a) To provide a new protocol to improve to anatomical and
      physiological response of DF.

      b) To compare the efficacy of combined hydrogel and honey products on DF ulcer.

      Specific objectives:

        1. To compare the healing time between the patients treated with hydrogel/honey products
           and the control treatment patients.

        2. To compare Lab parameters improvements between the patients treated with hydrogel/honey
           products and the control treatment patient such as CSR and WBC, etc.

        3. To compare neurological improvements between the patients treated with hydrogel/honey
           products and the control treatment patients.

        4. To compare the anatomical improvements between the patients treated with hydrogel/honey
           products and the control treatment patients.

           8 The study will be conducted using single blinded randomized clinical trial from
           October 2018 to February 2021, it will be conducted on DF patients with any stage of
           diabetic foot ulcer in the Center of Diabetic Foot, King Fahad specialist hospital
           Al-Qassim KSA.

           Randomization will be performed as block randomization with a 1:3 allocation.

           Methods: Participants, interventions, and outcomes Study setting 9 Outpatients DM type 2
           patients, follow up at diabetic foot center. Centre of diabetic foot, King Fahad
           Specialist Hospital Al- Qassim KSA.

           Eligibility criteria 10 1.1.1. Inclusion Criteria:

           It is mandatory for all of the participants to follow each of the following criteria:

             -  Adult more or equal 18 years with type 2 DM.

             -  Diagnosed with stable DF with any stage of foot ulcer

           Exclusion Criteria:

           • Patients with unstable severe conditions who requires hospitalization.

           • Patients with incomplete data and those who decided to withdraw.

             -  Read and understood the consent of the research and didn't approve to participate
                accordingly.

             -  Patients with open osteomyelitis with discharged us.

             -  DM patients with ischemic peripheral PAD gangrene.

             -  Charcoat diabetic foot CDF.

           Interventions 11a Patients will be divided into 4 groups:

           1st group will be treated with topical Medihoney gel product and empiric antibiotic
           (systematic) until the result of culture swab wound appears.

           2nd group will be treated with topical Hydrogel (purloin) gel and empiric antibiotic
           (systematic) until the result of culture swab wound appears.

           3rd group will be treated with a combination of topical Medihoney gel and Hydrogel
           (purloin) gel and empiric antibiotic (systematic) until the result of culture swab wound
           appears.

           The 4th group will be treated with a combination of systematic and topical Fucidin
           ointment 1% and empiric antibiotics, (systematic) this group will be a controlled group
           until the result of culture swab wound appears.

           11b Medihoney Gel, Purloin Gel, Fucidin Ointment 1% placebo drug 11c All groups will be
           monitored and the prospects for clinical, neurological, and anatomical, improvements
           will be followed up by the laboratory.

           11d For 3-12 weeks: Close observation and monitoring the topical treatment

           Appearance of ischemic arterial disease during participation Contraindication Treatment
           DFU(Allergic) As well as termination of participant

           Outcomes 12 Main Outcome Measurement:

           Ulcer size • Baseline: Size of the Ulcer before the beginning of treatment • Size will
           be monitored upon the commencement of the treatment until reaching the healing
           condition.

           • Main measurement: Time needed to reach the condition of fully healing of the ulcer
           (ULCER SIZE IS ZERO) Participant timeline 13 Dressing patient daily. Measurement of
           wound every week. This will continue for 3-12 weeks with DF patients. Sample size 14
           Sample size calculation

           Studies that are analyzed by chi-square or Fisher's exact test calculated sample size
           with professor statistical in the CUCMS

           Alpha is 5% Estimated power of the study: 80% Ratio of unexposed to exposed 3 (3 groups
           of treatment to 1 control group) Expected of unexposed with outcome incidence Expected
           exposed with outcome incidence

           The sample size formula without the correction factor by Fleiss is:

      α: The probability of type I error 5% β: The probability of type II error 20% Zalpha/2=1.96
      Zbetta/2=0.842 P0: The proportion of people with control treatment applied in population 1
      (0.70) P1: The proportion of people with random treatment applied in population 3 (0.95) r:
      The ratio of unexposed to exposed 0.33 NFleiss: Required sample size for the population 1
      using Fleiss formula According to the equation N Fleiss should be 30 per group patients.

      Recruitment 15 Targeted Sample size:

      Our sample size will be 120 patients (due to possibility and cost effectivity) designed as 30
      patients in each group.

      Methods: Assignment of interventions (for controlled trials)

      Allocation: Matching will be done depending on 3 variables:

        -  Gender:

        -  Age:

        -  Dounis classification:

      Type I Type II Type III (A,B,C)

      Sequence generation 16a Participants will be randomly assigned to either control or
      experimental group with a 1:3 allocation

      Type of randomization: single, blind randomization convenient for all patients follow up in
      the DF center, with matching factors; age, gender, Dounis anatomical classification.

      Allocation concealment mechanism 16b Participants will randomised using central randomisation
      service. Allocation concealment will be ensured, as the service will not release the
      randomization code until the patient has been recruited into the trial, which takes place
      after all baseline measurements have been completed.

      Implementation 16c All patients who give consent for participation and who fulfil the
      inclusion criteria will be randomized. Randomization will be requested by the staff member
      responsible for recruitment and clinical interviews from CenTrial [Coordination Centre of
      Clinical Trials]. In return, CenTrial will send an answer form to the study therapist who is
      not involved in assessing outcome of the study. This form will include a randomization
      number. In every center closed envelopes with printed randomization numbers on it are
      available. For every randomization number the corresponding code for the therapy group of the
      randomization list will be found inside the envelopes. The therapist will open the envelope
      and will find the treatment condition to be conducted in this patient. The therapist the
      gives the information about treatment allocation to the patient. Staff responsible for
      recruitment and symptom ratings is not allowed to receive information about the group
      allocation.

      Blinding (masking) 17a Due to the nature of the intervention, participants can be blinded to
      allocation but are strongly inculcated not to disclose the allocation status of the
      participant at the follow up assessments. An employee outside the research team will feed
      data into the computer in separate datasheets so that the researchers can analyze data
      without having access to information about the allocation.

      17b If un-blinding is deemed to be necessary, the investigator should use the system for
      emergency un-blinding through the local emergency number as the back-up system.

      Methods: Data collection, management, and analysis Data collection methods 18a Plans for
      assessment and collection of outcome, baseline, and other trial data, including any related
      processes to promote data quality (eg, duplicate measurements, training of assessors) and a
      description of study instruments (eg, questionnaires, laboratory tests) along with their
      reliability and validity, if known. Reference to where data collection forms can be found, if
      not in the protocol

      Main Outcome Measurement:

      Ulcer size • Baseline: Size of the Ulcer at the before the beginning of treatment

      • Size will be monitored upon the commencement of the treatment until reaching the healing
      condition.

      • Main measurement: Time needed to reach the condition of fully heal of the ulcer (ULCER SIZE
      IS ZERO) Quality Control of the Core Lab Data from the Core Lab will be securely transmitted
      in batches and quality controlled in the same manner as Core Coordinating Center Data.

      18b Provide written feedback to all patients about the results of the health screening.
      Maintain interest in the study through materials and mailing. Send letters to patients prior
      to the final data collection, reminding them of the upcoming data collection.

      Participants may withdraw from the study for any reason at any time. The investigator also
      may withdraw participants from the study in order to protect their safety and/or if they are
      unwilling or unable to comply with required study procedures after consultation with the
      protocol chair.

      Data management 19 Participant files are to be stored in numerical order and stored in a
      secure and accessible place and manner. Participant files will be maintained in storage for a
      period of 3 years after completion of the study.

      Weekly reports with information on missing data, missing forms, and missing visits. Personnel
      at the Core Coordinating Center and the Participating Sites should review these reports for
      accuracy and report any discrepancies to the investigator.

      Statistical methods 20a Statistical methods for analyzing primary and secondary outcomes.
      Reference to where other details of the statistical analysis plan can be found, if not in the
      protocol

      Analysis methods will depend on the improvements according to Dounis classification, as well
      as each of the clinical, neurological, anatomical, and angiographic improvement rate.

      20b Methods for any additional analyses (eg, subgroup and adjusted analyses)

      The data will be analyzed using version 23 of SPSS statistical software (SPSS Inc., Chicago,
      IL, USA). Descriptive statistics will be calculated as proportions or as means (with standard
      deviations) as appropriate. The significance level will be set as p value<0.05.

      20c The investigators propose declaring medical management non-inferior to interventional
      therapy, only if shown to be non-inferior using both the "intention to treat" and "per
      protocol" analysis sets.

      Methods: Monitoring Data monitoring 21a The DMC is independent of the study organizers.
      During the period of recruitment to the study, interim analyses will be supplied, in strict
      confidence, to the DMC, together with any other analyses that the committee may request. This
      may include analyses of data from other comparable trials.

      21b An interim-analysis is performed on the primary endpoint when 50% of patients have been
      randomized and have completed the 6 months follow-up.

      Harms 22 Adverse events will be collected after the subject has provided consent and enrolled
      in the study. If a subject experiences an adverse event after the informed consent document
      is signed (entry) but the subject has not started to receive study intervention.

      Auditing 23 The quality and completeness of the data will be reflective of the state of the
      art in clinical trials. The focus of the visit/electronic monitoring will be on source
      document review and confirmation of adverse events. The monitor will verify the following
      variables for all patients: initials, date of birth, sex, signed informed consent,
      eligibility criteria, date of randomization, treatment assignment, adverse events, and
      endpoints.

      Ethics and dissemination Research ethics approval 24 The protocol, site-specific informed
      consent forms (local language and English versions), participant education and recruitment
      materials, and other requested documents-and any subsequent modifications - also will be
      reviewed and approved by the ethical review bodies.

      The Investigator will make safety and progress reports and summaries review of safety and/or
      efficacy.

      Protocol amendments 25 Any modifications to the protocol which may impact on the conduct of
      the study, potential benefit of the patient or may affect patient safety, including changes
      of study objectives, study design, patient population, sample sizes, study procedures, or
      significant administrative aspects will require a formal amendment to the protocol.

      Consent or assent 26a Trained Research Nurses will introduce the trial to patients who will
      receive information sheets. Research Nurses will discuss the trial with patients in light of
      the information provided in the information sheets. Patients will then be able to have an
      informed discussion with the participating consultant. Research Nurses will obtain written
      consent from patients willing to participate in the trial. Information sheets and consent
      forms are provided for all parents involved in the trial

      26b A materials consent will be obtained to specifically address the collection

      Confidentiality 27 All study-related information will be stored securely at the study site.
      All participant information will be stored in locked file cabinets in areas with limited
      access. All laboratory specimens, reports, data collection, process, and administrative forms
      will be identified by a coded ID [identification] number only to maintain participant
      confidentiality. All records that contain names or other personal identifiers, such as
      locator forms and informed consent forms, will be stored separately from study records
      identified by code number. All local databases will be secured with password-protected access
      systems. Forms, lists, logbooks, appointment books, and any other listings that link
      participant ID numbers to other identifying information will be stored in a separate, locked
      file in an area with limited access.

      Declaration of interests 28 He does not have any paid consultancies with pharmaceutical
      companies, and is not a member of the Speaker's Panel of any company.

      Access to data 29 All Principal Investigators will be given access to the cleaned data sets.
      Project data sets will be housed on the Project Accept Web site and/or the file transfer
      protocol site created for the study, and all data sets will be password protected. Project
      Principal Investigators will have direct access to their own site's data sets, and will have
      access to other sites data by request. To ensure confidentiality, data dispersed to project
      team members will be blinded of any identifying participant information

      Ancillary and post-trial care 30 The liability of the manufacturer is strictly limited to
      those claims arising from faulty manufacturing of the commercial product and not to any
      aspects of the conduct of the study.

      Dissemination policy 31a The Publications subcommittee will review all publications following
      the guidelines and report its recommendations to the Steering Committee.

      the scientific integrity of the project requires that the data from all BEST Evaluation of
      Survival Trial sites be analyzed study-wide and reported Each paper must be submitted to the
      appropriate Subcommittee for review of its appropriateness and scientific merit prior to
      submission.

      31b There are three classes of reports;

      a) Reports of the major outcomes of the study. b) Reports addressing in detail one aspect. c)
      Reports of data derived from a subset of centers.

      31c Data sharing statement No later than 3 years after the collection of the 2-year post
      randomization interviews, The investigators will deliver a completely de-identified data set
      to an appropriate data archive for sharing purposes Appendices Informed consent materials 32
      Study number: Not available Investigator Name: Dr. Wael Searan Address: Center Endocrinology
      and Diabetes, Buraidah, Al-Qassim, KSA. Consent Form: This consent form is part of the
      informed consent process. It is designed to give you an idea of what this research study is
      about and what will happen to you if you choose to be in the study…

      Biological specimens 30

      In my study measurement there is no any biological specimens.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: PROSPECTIVE
primary purpose: Treatment
masking: Single (Participant)
measure: Ulcer size
time frame: FROM 3 WEEKS UP TO 12 WEEKS
description: ULCER SIZE
arm group label: CONTROL
arm group type: Experimental
description: CONTROL GROUP
arm group label: TREATMENT1
arm group type: Experimental
description: TREATMENT GROUP 1
arm group label: TREATMENT2
arm group type: Experimental
description: TREATMENT GROUP 2
arm group label: TREATMENT3
arm group type: Experimental
description: TREATMENT GROUP 3
intervention type: Drug
intervention name: Medihoney Gel in A Tube
description: TREATMENT1
arm group label: TREATMENT1
arm group label: TREATMENT3
other name: MEDIHONEY
intervention type: Drug
intervention name: Hydrogel
description: PURLOIN GEL
arm group label: TREATMENT2
arm group label: TREATMENT3
other name: PURLOIN
intervention type: Drug
intervention name: Fucidin Ointment
description: FUCIDIN ANTIBIOTIC OINTMENT 10%
arm group label: CONTROL
other name: FUCIDIN OINTMENT 10%
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Saudi Arabia
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Fusidic Acid
sharing ipd: No
study doc: 