xml: <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/NCT06000371</url>
    </required_header>
    <id_info>
      <org_study_id>MS.20.03.1083</org_study_id>
      <nct_id>NCT06000371</nct_id>
    </id_info>
    <brief_title>Cutoff Value of Ankle Brachial Pressure Index for Vacuum Assisted Closure Application in Diabetic Foot Ulcers</brief_title>
    <official_title>Cutoff Value of Ankle Brachial Pressure Index for Vacuum Assisted Closure Application in Diabetic Foot Ulcers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mansoura University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mansoura University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Abstract Objective To verify cutoff value of ankle brachial pressure index at which diabetic&#xD;
        foot ulcers get benefit from vacuum assisted closure application and to assess impact of its&#xD;
        application on ankle brachial pressure index value in the presence of peripheral arterial&#xD;
        disease.&#xD;
  &#xD;
        Methods An observational descriptive prospective analytic study had been performed.56&#xD;
        patients were enrolled in the study. All patients had three sessions of vacuum-assisted&#xD;
        closure application. Debridement was done when indicated. Ulcer dimensions were measured&#xD;
        before and after each session, while ankle brachial pressure index was measured before the&#xD;
        first session .&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Introduction Diabetes Mellitus (DM) is a chronic disease, which is considered a global public&#xD;
        health problem that leads to major clinical, economic, social, and quality of patient life&#xD;
        issues (1). 15% of diabetics will develop a diabetic foot ulcer (DFU) during their lifetime,&#xD;
        which is an exceedingly expensive and disabling complication of diabetes mellitus. (2).&#xD;
  &#xD;
        Assessment of foot perfusion is a crucial step in treatment of patients with DFU. The&#xD;
        ankle-brachial pressure index (ABPI) is a simple, quick, non-invasive tool (3). The key&#xD;
        elements of effective DFU management are clinical awareness, appropriate blood glucose&#xD;
        levels, regular foot exams, therapeutic footwear that fits the patient, off-loading, local&#xD;
        wound care, and the identification and treatment of osteomyelitis and ischemia (4).&#xD;
  &#xD;
        Multiple adjuvant therapies have been studied to decrease DFU healing times and amputation&#xD;
        rates. These therapies include negative pressure wound therapy (vacuum-assisted closure),&#xD;
        non-surgical debridement agents, oxygen therapies, human growth factors, energy based&#xD;
        therapies, and systemic therapies(5).Cellular and/ or tissue based product (CTPs) may result&#xD;
        in higher average number of ulcer free months and lower average number of amputations and&#xD;
        resections compared to standard of care (SOC) alone (6).&#xD;
  &#xD;
        Negative pressure wound therapy (NPWT) is a non-invasive therapy that removes fluid from&#xD;
        wounds, prepares the wound bed for closure, reduces edema, and promotes the creation and&#xD;
        perfusion of granulation tissue by applying regulated negative pressure using a&#xD;
        vacuum-assisted closure (VAC) device (7). NPWT is indicated in traumatic, acute wounds,&#xD;
        sub-acute wounds (i.e. dehisced incisions), chronic open wounds (stasis ulcers and diabetic&#xD;
        ulcers), pressure ulcers, flaps and meshed graft (8).&#xD;
  &#xD;
        We conducted this this study to verify cutoff value of ABPI at which diabetic foot ulcers get&#xD;
        benefit from VAC application.&#xD;
  &#xD;
        Methods A single-center prospective observational study had been performed. Between March&#xD;
        2020 and May 2021, 56 patients with DFUs underwent VAC application in the Department of&#xD;
        Vascular Surgery. The inclusion criteria consisted of the following: the patient ≥40 years&#xD;
        with unhealed diabetic foot ulcers belonged to grade 1 or grade 2 (in both wound and&#xD;
        infection categories of wound, ischemia and wound infection &quot; WIFI classification) . Patients&#xD;
        with immunocompromised status, varicose veins, chronic venous insuffiency, foot ulcers&#xD;
        belonged to grade 3 (in both wound and infection categories of WIFI classification) . All&#xD;
        patients who were involved in the study gave their written consent.&#xD;
  &#xD;
        The patients were subjected to history taking including history of foot ulceration,&#xD;
        amputation, symptoms of claudication, neurologic changes, vascular surgery and medical&#xD;
        comorbidities. The site, shape, base and margins of the ulcer had been clinically examined.&#xD;
        The clinical manifestations of infection including erythema, warmth, swelling, pain or&#xD;
        tenderness were searched for. Proper neurological and vascular examination had been applied&#xD;
        to all included feet. The following investigations were done: duplex U/S on arterial system&#xD;
        (for all patients), X-ray (in case of suspected infected collections or osteomyelitis) and CT&#xD;
        angiography (when duplex is inconclusive).&#xD;
  &#xD;
        Procedure description:&#xD;
  &#xD;
        Prior to VAC application, ABPI was measured and documented with using of Bistos hi dop&#xD;
        vascular Doppler with 8MHZ probe (Bistos Co., Ltd. Galmachi-ro, Jungwon-gu, Seongnam-si,&#xD;
        Gyeonggi-do, Korea) and mercurial sphygmomanometer (ALPK2, 300v velcro cuff, Japan) according&#xD;
        to the procedure described by the American College of Cardiology (ACC) and the American Heart&#xD;
        Association (AHA) guidelines (9) and ulcer was prepared by debridement of devitalized tissue,&#xD;
        proper hemostasis and wound irrigation with saline .&#xD;
  &#xD;
        Then, length, width and depth of the ulcer were measured by metal ruler and documented. The&#xD;
        ulcer was gently filled with foam, ensuring that the foam was slightly above the ulcer edge.&#xD;
        The drain was placed between foam layers. The drape was sized and trimmed to cover the entire&#xD;
        ulcer as well as about 3-5 cm of intact skin around it. The drape shouldn't be stretched or&#xD;
        under tension. Adhesive plaster was used at edges to maintain sealing and negative suction .&#xD;
  &#xD;
        The dressing drain was attached to canister tube with opening the clamp. The suction pressure&#xD;
        was adjusted at-120 mmHg with intermittent mode. If the patient experienced bleeding despite&#xD;
        good hemostasis or pain that was not relieved by analgesics, pressure can be reduced by&#xD;
        10mmHg. Power button was pressed to turn on Smith&amp; Nephew Renesys EZ plus NPWT device (Smith&#xD;
        &amp; Nephew Medical Ltd. Hull HU3 2BN, England. The patient was informed about steps of&#xD;
        disconnection and maximum period of disconnection 2hours /day. Patient or his/her relative&#xD;
        was informed about causes of alarm e.g. low pressure, full canister, line blockage and low&#xD;
        battery and how to manage them.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 25, 2020</start_date>
    <completion_date type="Actual">October 2, 2021</completion_date>
    <primary_completion_date type="Actual">May 1, 2021</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Dimensions of diabetic foot ulcer (manual measurement of length, width and depth of the ulcer by metal ruler).</measure>
      <time_frame>Up to3 weeks</time_frame>
      <description>Change of dimensions of diabetic foot ulcers. The higher values mean a worse outcome.</description>
    </primary_outcome>
    <enrollment type="Actual">56</enrollment>
    <condition>Diabetic Foot</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Vacuum assisted Closure application</intervention_name>
      <description>Vacuum assisted Closure Application in Diabetic Foot Ulcers</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          patient ≥40 years with unhealed diabetic foot ulcers belonged to grade 1 or grade 2 (in&#xD;
          both wound and infection categories of WIFI classification) .&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient ≥40 years.&#xD;
  &#xD;
            -  Unhealed diabetic foot ulcers.&#xD;
  &#xD;
            -  Ulcers belonged to grade 1 or grade 2 (in both wound and infection categories &quot;WIFI&quot;&#xD;
               classification) .&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Immunocompromised patients.&#xD;
  &#xD;
            -  Patient with varicose veins and chronic venous insufficiency.&#xD;
  &#xD;
            -  Foot ulcers belonged to grade 3 (in both wound and infection categories of WIFI&#xD;
               classification)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mansoura university</last_name>
      <role>Principal Investigator</role>
      <affiliation>MU</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Mansoura university</name>
        <address>
          <city>Mansoura</city>
          <state>Dakahlia</state>
          <zip>35511</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>1. Bonoto BC, de Araújo VE, Godói IP, de Lemos LLP, Godman B, Bennie M, et al. Efficacy of mobile apps to support the care of patients with diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials. JMIR mHealth and uHealth. 2017;5(3):e4. 2. Yazdanpanah L, Nasiri M, Adarvishi S. Literature review on the management of diabetic foot ulcer. World journal of diabetes. 2015;6(1):37. 3. Hajibandeh S, Hajibandeh S, Shah S, Child E, Antoniou GA, Torella F. Prognostic significance of ankle brachial pressure index: a systematic review and meta-analysis. Vascular. 2017;25(2):208-24. 4. Mavrogenis AF, Megaloikonomos PD, Antoniadou T, Igoumenou VG, Panagopoulos GN, Dimopoulos L, et al. Current concepts for the evaluation and management of diabetic foot ulcers. EFORT open reviews. 2018;3(9):513-25. 5. Everett E, Mathioudakis N. Update on management of diabetic foot ulcers. Annals of the New York Academy of Sciences. 2018;1411(1):153. 6. Serena TE, Yaakov RA, Mostow EN. Use of Cellular and Tissue-based Product in the Treatment of Diabetic Foot Ulcers. The Journal of Foot and Ankle Surgery (Asia-Pacific). 2016;3(2):92-6. 7. Lone AM, Zaroo MI, Laway BA, Pala NA, Bashir SA, Rasool A. Vacuum-assisted closure versus conventional dressings in the management of diabetic foot ulcers: a prospective case-control study. Diabetic foot &amp; ankle. 2014;5(1):23345. 8. Yadav S, Rawal G, Baxi M. Vacuum assisted closure technique: a short review. The Pan African Medical Journal. 2017;28. 9. Aboyans V, Criqui MH, Abraham P, Allison MA, Creager MA, Diehm C, et al. Measurement and interpretation of the ankle-brachial index: a scientific statement from the American Heart Association. Circulation. 2012;126(24):2890-909.</citation>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetic Foot</mesh_term>
      <mesh_term>Foot Ulcer</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06000371
  org study id: MS.20.03.1083
  nct id: NCT06000371
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  Abstract Objective To verify cutoff value of ankle brachial pressure index at which diabetic
        foot ulcers get benefit from vacuum assisted closure application and to assess impact of its
        application on ankle brachial pressure index value in the presence of peripheral arterial
        disease.
  
        Methods An observational descriptive prospective analytic study had been performed.56
        patients were enrolled in the study. All patients had three sessions of vacuum-assisted
        closure application. Debridement was done when indicated. Ulcer dimensions were measured
        before and after each session, while ankle brachial pressure index was measured before the
        first session .
  Introduction Diabetes Mellitus (DM) is a chronic disease, which is considered a global public
        health problem that leads to major clinical, economic, social, and quality of patient life
        issues (1). 15% of diabetics will develop a diabetic foot ulcer (DFU) during their lifetime,
        which is an exceedingly expensive and disabling complication of diabetes mellitus. (2).
  
        Assessment of foot perfusion is a crucial step in treatment of patients with DFU. The
        ankle-brachial pressure index (ABPI) is a simple, quick, non-invasive tool (3). The key
        elements of effective DFU management are clinical awareness, appropriate blood glucose
        levels, regular foot exams, therapeutic footwear that fits the patient, off-loading, local
        wound care, and the identification and treatment of osteomyelitis and ischemia (4).
  
        Multiple adjuvant therapies have been studied to decrease DFU healing times and amputation
        rates. These therapies include negative pressure wound therapy (vacuum-assisted closure),
        non-surgical debridement agents, oxygen therapies, human growth factors, energy based
        therapies, and systemic therapies(5).Cellular and/ or tissue based product (CTPs) may result
        in higher average number of ulcer free months and lower average number of amputations and
        resections compared to standard of care (SOC) alone (6).
  
        Negative pressure wound therapy (NPWT) is a non-invasive therapy that removes fluid from
        wounds, prepares the wound bed for closure, reduces edema, and promotes the creation and
        perfusion of granulation tissue by applying regulated negative pressure using a
        vacuum-assisted closure (VAC) device (7). NPWT is indicated in traumatic, acute wounds,
        sub-acute wounds (i.e. dehisced incisions), chronic open wounds (stasis ulcers and diabetic
        ulcers), pressure ulcers, flaps and meshed graft (8).
  
        We conducted this this study to verify cutoff value of ABPI at which diabetic foot ulcers get
        benefit from VAC application.
  
        Methods A single-center prospective observational study had been performed. Between March
        2020 and May 2021, 56 patients with DFUs underwent VAC application in the Department of
        Vascular Surgery. The inclusion criteria consisted of the following: the patient ≥40 years
        with unhealed diabetic foot ulcers belonged to grade 1 or grade 2 (in both wound and
        infection categories of wound, ischemia and wound infection " WIFI classification) . Patients
        with immunocompromised status, varicose veins, chronic venous insuffiency, foot ulcers
        belonged to grade 3 (in both wound and infection categories of WIFI classification) . All
        patients who were involved in the study gave their written consent.
  
        The patients were subjected to history taking including history of foot ulceration,
        amputation, symptoms of claudication, neurologic changes, vascular surgery and medical
        comorbidities. The site, shape, base and margins of the ulcer had been clinically examined.
        The clinical manifestations of infection including erythema, warmth, swelling, pain or
        tenderness were searched for. Proper neurological and vascular examination had been applied
        to all included feet. The following investigations were done: duplex U/S on arterial system
        (for all patients), X-ray (in case of suspected infected collections or osteomyelitis) and CT
        angiography (when duplex is inconclusive).
  
        Procedure description:
  
        Prior to VAC application, ABPI was measured and documented with using of Bistos hi dop
        vascular Doppler with 8MHZ probe (Bistos Co., Ltd. Galmachi-ro, Jungwon-gu, Seongnam-si,
        Gyeonggi-do, Korea) and mercurial sphygmomanometer (ALPK2, 300v velcro cuff, Japan) according
        to the procedure described by the American College of Cardiology (ACC) and the American Heart
        Association (AHA) guidelines (9) and ulcer was prepared by debridement of devitalized tissue,
        proper hemostasis and wound irrigation with saline .
  
        Then, length, width and depth of the ulcer were measured by metal ruler and documented. The
        ulcer was gently filled with foam, ensuring that the foam was slightly above the ulcer edge.
        The drain was placed between foam layers. The drape was sized and trimmed to cover the entire
        ulcer as well as about 3-5 cm of intact skin around it. The drape shouldn't be stretched or
        under tension. Adhesive plaster was used at edges to maintain sealing and negative suction .
  
        The dressing drain was attached to canister tube with opening the clamp. The suction pressure
        was adjusted at-120 mmHg with intermittent mode. If the patient experienced bleeding despite
        good hemostasis or pain that was not relieved by analgesics, pressure can be reduced by
        10mmHg. Power button was pressed to turn on Smith& Nephew Renesys EZ plus NPWT device (Smith
        & Nephew Medical Ltd. Hull HU3 2BN, England. The patient was informed about steps of
        disconnection and maximum period of disconnection 2hours /day. Patient or his/her relative
        was informed about causes of alarm e.g. low pressure, full canister, line blockage and low
        battery and how to manage them.
  observational model: Case-Only
  time perspective: Prospective
  measure: Dimensions of diabetic foot ulcer (manual measurement of length, width and depth of the ulcer by metal ruler).
  time frame: Up to3 weeks
  description: Change of dimensions of diabetic foot ulcers. The higher values mean a worse outcome.
  intervention type: Device
  intervention name: Vacuum assisted Closure application
  description: Vacuum assisted Closure Application in Diabetic Foot Ulcers
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mansoura university
  role: Principal Investigator
  affiliation: MU
  facility: 
  country: Egypt
  citation: 1. Bonoto BC, de Araújo VE, Godói IP, de Lemos LLP, Godman B, Bennie M, et al. Efficacy of mobile apps to support the care of patients with diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials. JMIR mHealth and uHealth. 2017;5(3):e4. 2. Yazdanpanah L, Nasiri M, Adarvishi S. Literature review on the management of diabetic foot ulcer. World journal of diabetes. 2015;6(1):37. 3. Hajibandeh S, Hajibandeh S, Shah S, Child E, Antoniou GA, Torella F. Prognostic significance of ankle brachial pressure index: a systematic review and meta-analysis. Vascular. 2017;25(2):208-24. 4. Mavrogenis AF, Megaloikonomos PD, Antoniadou T, Igoumenou VG, Panagopoulos GN, Dimopoulos L, et al. Current concepts for the evaluation and management of diabetic foot ulcers. EFORT open reviews. 2018;3(9):513-25. 5. Everett E, Mathioudakis N. Update on management of diabetic foot ulcers. Annals of the New York Academy of Sciences. 2018;1411(1):153. 6. Serena TE, Yaakov RA, Mostow EN. Use of Cellular and Tissue-based Product in the Treatment of Diabetic Foot Ulcers. The Journal of Foot and Ankle Surgery (Asia-Pacific). 2016;3(2):92-6. 7. Lone AM, Zaroo MI, Laway BA, Pala NA, Bashir SA, Rasool A. Vacuum-assisted closure versus conventional dressings in the management of diabetic foot ulcers: a prospective case-control study. Diabetic foot & ankle. 2014;5(1):23345. 8. Yadav S, Rawal G, Baxi M. Vacuum assisted closure technique: a short review. The Pan African Medical Journal. 2017;28. 9. Aboyans V, Criqui MH, Abraham P, Allison MA, Creager MA, Diehm C, et al. Measurement and interpretation of the ankle-brachial index: a scientific statement from the American Heart Association. Circulation. 2012;126(24):2890-909.
  responsible party type: Sponsor
  mesh term: Diabetic Foot
  mesh term: Foot Ulcer
  sharing ipd: Undecided