<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/NCT02990832</url>
  </required_header>
  <id_info>
    <org_study_id>AICE-201500872</org_study_id>
    <nct_id>NCT02990832</nct_id>
  </id_info>
  <brief_title>Diabetes Foot Care Clinical Pathway Project - Exciton Technologies Inc</brief_title>
  <acronym>DFCCP-Exciton</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alberta Innovates Health Solutions</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Exciton Technologies Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In 2011, the premiers of all Canadian provinces and territories selected diabetes foot care&#xD;
      as 1 of 3 significant targets for pan-provincial action. Of 210,000 people with diabetes in&#xD;
      Alberta, 5,250 will seek treatment of a foot ulcer annually. In Alberta in 2014-15 there were&#xD;
      425 lower limb amputations (LLA). Moreover, there is a tremendous reduction in quality of&#xD;
      life of the patients and attendant negative effects on their families. The 5-year mortality&#xD;
      rate after new-onset diabetic foot ulcer is 43-55% and as high as 74% for patients undergoing&#xD;
      LLA (CIHI, 2013). The Diabetes Foot Care Clinical Pathway Project (DFCCPP) aims to optimize&#xD;
      methods of early detection and treatment of foot ulcers in an effort to reduce LLA by 50% by&#xD;
      implementing High Risk Foot Teams (HRFTs) across the province starting with 3 Pilot sites.&#xD;
      Existing staff with expertise and knowledge in diabetic foot care will assess and treat&#xD;
      patients with moderate and high-risk findings.&#xD;
&#xD;
      In conjunction with the DFCCPP, the efficacy of a technological advancement developed by an&#xD;
      Alberta-based small-to-medium enterprise (SME) to improve diabetic foot outcomes will be&#xD;
      evaluated. Exsalt® SD7 Wound Dressings (Exciton Technologies, Edmonton, AB) have been&#xD;
      demonstrated in-vitro and in-vivo to provide rapid and effective antibacterial activity in an&#xD;
      easy-to-use format, thus creating an enhanced wound healing environment while supporting&#xD;
      patient quality of life.&#xD;
&#xD;
      The objective of the proposed work is twofold, namely 1) to quantify clinical efficacy of&#xD;
      exsalt® Wound Dressings on locally infected diabetic foot ulcers not progressing to healing&#xD;
      under the current standard of care: evaluating key indicators of infection, Infectious&#xD;
      Diseases Society of America (IDSA) wound classification, and wound size; identifying benefits&#xD;
      to foot ulcer healing and 2) to evaluate subjective patient outcomes: satisfaction, perceived&#xD;
      benefit, compliance. Evaluating the benefits of utilization of the Exciton exsalt® Wound&#xD;
      Dressings when combined with the DFCCP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      2 Background Information&#xD;
&#xD;
      2.1 Device Description&#xD;
&#xD;
      Exsalt® Wound Dressings (Test Dressings) contain oxidized silver oxysalts deposited&#xD;
      throughout a non-woven polyester/High density polyethylene non-adherent dressing. Silver in&#xD;
      the exsalt® Wound Dressings inhibits microbial growth in the dressing. The concentration of&#xD;
      the silver and oxidized silver species on the dressing is 0.4 mg/cm2 (2.5% w/w). The exsalt®&#xD;
      dressings have been shown to be effective in vitro against Staphylococcus aureus, Escherichia&#xD;
      coli, Pseudomonas aeruginosa, and Enterococcus faecalis. Exsalt® Wound Dressings maintain&#xD;
      their antibacterial activity for up to 7 days against Pseudomonas aeruginosa and&#xD;
      Staphylococcus aureus.&#xD;
&#xD;
      Exsalt® Wound Dressings are indicated for the management of partial and full thickness&#xD;
      wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second&#xD;
      degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be&#xD;
      used over debrided and grafted wounds.&#xD;
&#xD;
      2.2 Study History&#xD;
&#xD;
      The Canadian Institute of Health Information estimates that foot wounds (with diabetes as the&#xD;
      leading cause) are present in 4% of all hospital inpatients, 7% of homecare clients and 10%&#xD;
      of long-term care residents (CIHI, 2013). Ulcerations are a critical event in the loss of&#xD;
      limbs or amputation as they create an avenue for infection and may exacerbate necrotic tissue&#xD;
      and ischemia. Of 210,000 people with diabetes in Alberta, 5,250 will seek treatment of a foot&#xD;
      ulcer annually. In Alberta in 2014-15 there were 425 LLA performed on 309 diabetic patients&#xD;
      representing an increase of 89 LLA over 2010-11.&#xD;
&#xD;
      The 5-year mortality rate after new-onset diabetic foot ulcer is 43-55% and as high as 74%&#xD;
      for patients undergoing LLA (Ollendorf et al, 1998). Moreover, there is a tremendous&#xD;
      reduction in quality of life of the patients and negative effects on their families. The&#xD;
      Diabetes Foot Care Clinical Pathway Project (DFCCPP) aims to optimize methods of early&#xD;
      detection and treatment of foot ulcers in an effort to reduce LLA by 50% and improve&#xD;
      patient's quality of life. Therefore, there is a need for an effective tool for the&#xD;
      prevention and management of local infection in diabetic foot ulcers.&#xD;
&#xD;
      2.3 Device History&#xD;
&#xD;
      Exsalt® wound dressings have to date been formally evaluated (including clinical studies and&#xD;
      post-market surveillance) on over 125 patients throughout North America and Europe. In these&#xD;
      studies, many wound etiologies were investigated including: venous leg ulcers, diabetic&#xD;
      ulcers, diabetic neuropathic ulcers, post-surgical wounds, wounds resulting from trauma, skin&#xD;
      tears, pressure ulcers, burn wounds, and chronic non-healing ulcers. The formal clinical&#xD;
      evaluations investigated the safety and efficacy of the Exsalt® wound dressing as a device.&#xD;
      Data and feedback generated supported wound healing, with increased granulation tissue and&#xD;
      lessened pain, odor, and signs of infection (Thomason et al, 2016; Lemire et al, 2015). The&#xD;
      wound dressing was shown to support progression to wound closure or wound healing without&#xD;
      signs of toxicity or side-effects.&#xD;
&#xD;
      2.4 Risk Summary&#xD;
&#xD;
      Precautions need to be taken when using exsalt® Wound Dressing as it should not be used on&#xD;
      patients with a known sensitivity to silver; is not compatible with oil-based products, such&#xD;
      as petrolatum; is not compatible with magnetic resonance imaging (MRI) procedures; should be&#xD;
      removed prior to administering radiation therapy; and should not come in contact with&#xD;
      electrodes and conductive gels during electronic measurements (e.g. EEG, ECG).&#xD;
&#xD;
      Additionally, frequent or prolonged use of Exsalt® wound dressings may result in permanent&#xD;
      discoloration of skin.&#xD;
&#xD;
      2.5 Benefit Summary&#xD;
&#xD;
      Benefits of this product vs. other silver antimicrobials include rapid and sustained&#xD;
      bactericidal activity; broad spectrum of activity; minimized pain; reduced staining of skin;&#xD;
      non-toxicity to human tissue; decreased likelihood of resistance; cost-effectiveness as it&#xD;
      requires less silver.&#xD;
&#xD;
      2.6 Good Clinical Practice and Regulatory Requirements&#xD;
&#xD;
      2.6.1 Regulatory Requirements: Exsalt® Wound Dressing&#xD;
&#xD;
      Exsalt® Wound Dressings exsalt® SD7 and exsalt® T7 have been licensed in Canada by Health&#xD;
      Canada as of January 2011 and March 2012, respectively. Exsalt® wound dressing is &quot;indicated&#xD;
      for the management of partial and full thickens wounds such as decubitus ulcers, venous&#xD;
      stasis ulcers, diabetic ulcers, 1st and 2nd degree burns, grafts and donor sites' or other&#xD;
      acute or chronic wounds.&quot;&#xD;
&#xD;
      3 Study Objectives &amp; Purpose&#xD;
&#xD;
      The purpose of this pilot study is to evaluate the effectiveness of the Exciton exsalt® Wound&#xD;
      Dressings when combined with the DFCCP in patients with locally infected diabetic foot&#xD;
      ulcers. The objective of the proposed work is twofold, namely 1) to quantify the&#xD;
      effectiveness of exsalt® Wound Dressings on locally infected diabetic foot ulcers not&#xD;
      progressing to healing under the current standard of care: evaluating IDSA wound&#xD;
      classification, pain, wound size, and signs and symptoms of infection through a one-arm&#xD;
      prospective repeated measures pilot study and 2) to compile subjective patient outcomes:&#xD;
      satisfaction, perceived benefit, compliance. Evaluating the benefits of utilization of the&#xD;
      Exciton exsalt® Wound Dressings when combined with the DFCCP.&#xD;
&#xD;
      Specifically, the following work and objectives are proposed:&#xD;
&#xD;
        1. A prospective, single-arm, repeated measures study to pilot the use of Exsalt® wound&#xD;
           dressing in chronic wounds within an outpatient clinical setting; evaluate the benefits&#xD;
           of utilization of exsalt® Wound Dressings within the DFCCPP.&#xD;
&#xD;
        2. Repeated measures evaluating and reporting wound infection classification (IDSA), pain&#xD;
           score, wound size, and key indicators of infection; pre and post-intervention.&#xD;
           Quantifying the impact of the intervention to diabetic foot ulcer local infection,&#xD;
           healing, and associated pain. Qualifying subjective patient outcomes including&#xD;
           satisfaction, benefit, and compliance. Incidence of safety and adverse events will be&#xD;
           reported within the scope of this pilot study.&#xD;
&#xD;
      3.1 Research Questions&#xD;
&#xD;
      The research proposed here is designed to address the following questions:&#xD;
&#xD;
        1. What is the impact (monitoring key indicators of infection, wound size, and wound&#xD;
           classification) of the application of the exsalt® Wound Dressing utilized as a primary&#xD;
           dressing for up to four weeks in outpatients with diabetic foot ulcers that have a mild&#xD;
           local infection and are non-responsive using standard-of-care.?&#xD;
&#xD;
        2. What is the clinical utility of the use of the Exsalt® wound dressing from the&#xD;
           perspective of clinical staff and patients?&#xD;
&#xD;
        3. What are the benefits of utilization of the Exciton exsalt® Wound Dressings when&#xD;
           combined with the DFCCP?&#xD;
&#xD;
      4 Pilot Study Design&#xD;
&#xD;
      4.1 Study type&#xD;
&#xD;
      A prospective, single-arm, repeated measures study pilot study will be coordinated by the&#xD;
      DON-SCN on the use of exsalt® Wound Dressings in mildly infected chronic diabetic foot ulcer&#xD;
      wounds within three outpatient clinical settings; evaluating pre and post-intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The study was deemed unfeasible to complete.&#xD;
  </why_stopped>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">May 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Infection assessed as per Infectious Disease Society of America (IDSA) guidelines</measure>
    <time_frame>28 days</time_frame>
    <description>Assessed as per Infectious Disease Society of America (IDSA) guidelines</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain assessed with Ordinal scale</measure>
    <time_frame>28 days</time_frame>
    <description>Ordinal scale, 0=none, 3=severe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound volume</measure>
    <time_frame>28 days</time_frame>
    <description>Wound area multiplied by wound depth (cubic centimetres)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and complications (incidence of adverse events)</measure>
    <time_frame>28 days</time_frame>
    <description>The principal measure of safety will be the incidence of adverse events reported during the study. Adverse events from patients will be noted and thoroughly documented. Patients who experience adverse events may or may not be withdrawn from the study, depending on the nature and timing of the event; study investigators will review and assess each adverse event on a case-by-case basis. Data for safety assessments will be collected from all completed adverse events reports.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Diabetic Foot Ulcer</condition>
  <arm_group>
    <arm_group_label>Exciton</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment of diabetic foot ulcer with Exciton Exsalt wound dressing</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Exciton</intervention_name>
    <description>Exsalt® Wound Dressings will be applied by the physician/nursing staff.&#xD;
The test product, exsalt® Wound Dressings (0.4 mg Ag/cm2) will be applied after wound cleansing or debridement if required.&#xD;
Dressings will be changed weekly, either at the out-patient facility or at home with provided dressings. At regular intervals throughout the study, as per the existing Diabetes Foot Care Clinical Care Pathway, wound assessment including size determination, Exsalt Wound Assessment Form, any adverse events will be reported, with tracing and/or photography included where available.&#xD;
Maximum treatment course will be 28 days (end of study) or until wound closure.</description>
    <arm_group_label>Exciton</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with diabetes mellitus according to definitions outlined by the American&#xD;
             Diabetes Association&#xD;
&#xD;
          -  Presenting with a localized mild infection of the ulcer as listed in the IDSA Clinical&#xD;
             Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections (Table&#xD;
             1); exceeding 0.5 cm2 in area after appropriate debridement&#xD;
&#xD;
          -  Diagnosis of mild infection must be confirmed immediately following debridement at&#xD;
             Baseline&#xD;
&#xD;
          -  Subject must agree to adhere to all protocol procedures and must be willing and able&#xD;
             to provide written informed consent.&#xD;
&#xD;
          -  Correction or optimization of underlying medical problems (e.g. diabetes or systemic&#xD;
             infection).&#xD;
&#xD;
          -  Wound has been identified as stalled or persistent non-healing under current&#xD;
             standard-of-care; showing no progression in 2 weeks as per IDSA guidelines&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of systemic antibiotics within the previous 2 weeks&#xD;
&#xD;
          -  Known silver sensitivity&#xD;
&#xD;
          -  Current use of enzymatic debridement&#xD;
&#xD;
          -  Wounds where best practice wound bed preparation is not available or applicable (eg,&#xD;
             wound with diminutive oxygen supply would be contraindicated for debridement.&#xD;
&#xD;
          -  No palpable dorsalis pedis or posterior tibial pulse or a pedal systolic pressure&#xD;
             (Doppler) of ≤ 40 mm Hg&#xD;
&#xD;
          -  Evidence of systemic infection (fever, chills, hypotension)/sepsis&#xD;
&#xD;
          -  Non-study systemic or anti-infective topical agents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>April 26, 2019</last_update_submitted>
  <last_update_submitted_qc>April 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alberta</investigator_affiliation>
    <investigator_full_name>Catherine Chan</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </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>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02990832
org study id: AICE-201500872
nct id: NCT02990832
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
In 2011, the premiers of all Canadian provinces and territories selected diabetes foot care
      as 1 of 3 significant targets for pan-provincial action. Of 210,000 people with diabetes in
      Alberta, 5,250 will seek treatment of a foot ulcer annually. In Alberta in 2014-15 there were
      425 lower limb amputations (LLA). Moreover, there is a tremendous reduction in quality of
      life of the patients and attendant negative effects on their families. The 5-year mortality
      rate after new-onset diabetic foot ulcer is 43-55% and as high as 74% for patients undergoing
      LLA (CIHI, 2013). The Diabetes Foot Care Clinical Pathway Project (DFCCPP) aims to optimize
      methods of early detection and treatment of foot ulcers in an effort to reduce LLA by 50% by
      implementing High Risk Foot Teams (HRFTs) across the province starting with 3 Pilot sites.
      Existing staff with expertise and knowledge in diabetic foot care will assess and treat
      patients with moderate and high-risk findings.

      In conjunction with the DFCCPP, the efficacy of a technological advancement developed by an
      Alberta-based small-to-medium enterprise (SME) to improve diabetic foot outcomes will be
      evaluated. Exsalt® SD7 Wound Dressings (Exciton Technologies, Edmonton, AB) have been
      demonstrated in-vitro and in-vivo to provide rapid and effective antibacterial activity in an
      easy-to-use format, thus creating an enhanced wound healing environment while supporting
      patient quality of life.

      The objective of the proposed work is twofold, namely 1) to quantify clinical efficacy of
      exsalt® Wound Dressings on locally infected diabetic foot ulcers not progressing to healing
      under the current standard of care: evaluating key indicators of infection, Infectious
      Diseases Society of America (IDSA) wound classification, and wound size; identifying benefits
      to foot ulcer healing and 2) to evaluate subjective patient outcomes: satisfaction, perceived
      benefit, compliance. Evaluating the benefits of utilization of the Exciton exsalt® Wound
      Dressings when combined with the DFCCP.
2 Background Information

      2.1 Device Description

      Exsalt® Wound Dressings (Test Dressings) contain oxidized silver oxysalts deposited
      throughout a non-woven polyester/High density polyethylene non-adherent dressing. Silver in
      the exsalt® Wound Dressings inhibits microbial growth in the dressing. The concentration of
      the silver and oxidized silver species on the dressing is 0.4 mg/cm2 (2.5% w/w). The exsalt®
      dressings have been shown to be effective in vitro against Staphylococcus aureus, Escherichia
      coli, Pseudomonas aeruginosa, and Enterococcus faecalis. Exsalt® Wound Dressings maintain
      their antibacterial activity for up to 7 days against Pseudomonas aeruginosa and
      Staphylococcus aureus.

      Exsalt® Wound Dressings are indicated for the management of partial and full thickness
      wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second
      degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be
      used over debrided and grafted wounds.

      2.2 Study History

      The Canadian Institute of Health Information estimates that foot wounds (with diabetes as the
      leading cause) are present in 4% of all hospital inpatients, 7% of homecare clients and 10%
      of long-term care residents (CIHI, 2013). Ulcerations are a critical event in the loss of
      limbs or amputation as they create an avenue for infection and may exacerbate necrotic tissue
      and ischemia. Of 210,000 people with diabetes in Alberta, 5,250 will seek treatment of a foot
      ulcer annually. In Alberta in 2014-15 there were 425 LLA performed on 309 diabetic patients
      representing an increase of 89 LLA over 2010-11.

      The 5-year mortality rate after new-onset diabetic foot ulcer is 43-55% and as high as 74%
      for patients undergoing LLA (Ollendorf et al, 1998). Moreover, there is a tremendous
      reduction in quality of life of the patients and negative effects on their families. The
      Diabetes Foot Care Clinical Pathway Project (DFCCPP) aims to optimize methods of early
      detection and treatment of foot ulcers in an effort to reduce LLA by 50% and improve
      patient's quality of life. Therefore, there is a need for an effective tool for the
      prevention and management of local infection in diabetic foot ulcers.

      2.3 Device History

      Exsalt® wound dressings have to date been formally evaluated (including clinical studies and
      post-market surveillance) on over 125 patients throughout North America and Europe. In these
      studies, many wound etiologies were investigated including: venous leg ulcers, diabetic
      ulcers, diabetic neuropathic ulcers, post-surgical wounds, wounds resulting from trauma, skin
      tears, pressure ulcers, burn wounds, and chronic non-healing ulcers. The formal clinical
      evaluations investigated the safety and efficacy of the Exsalt® wound dressing as a device.
      Data and feedback generated supported wound healing, with increased granulation tissue and
      lessened pain, odor, and signs of infection (Thomason et al, 2016; Lemire et al, 2015). The
      wound dressing was shown to support progression to wound closure or wound healing without
      signs of toxicity or side-effects.

      2.4 Risk Summary

      Precautions need to be taken when using exsalt® Wound Dressing as it should not be used on
      patients with a known sensitivity to silver; is not compatible with oil-based products, such
      as petrolatum; is not compatible with magnetic resonance imaging (MRI) procedures; should be
      removed prior to administering radiation therapy; and should not come in contact with
      electrodes and conductive gels during electronic measurements (e.g. EEG, ECG).

      Additionally, frequent or prolonged use of Exsalt® wound dressings may result in permanent
      discoloration of skin.

      2.5 Benefit Summary

      Benefits of this product vs. other silver antimicrobials include rapid and sustained
      bactericidal activity; broad spectrum of activity; minimized pain; reduced staining of skin;
      non-toxicity to human tissue; decreased likelihood of resistance; cost-effectiveness as it
      requires less silver.

      2.6 Good Clinical Practice and Regulatory Requirements

      2.6.1 Regulatory Requirements: Exsalt® Wound Dressing

      Exsalt® Wound Dressings exsalt® SD7 and exsalt® T7 have been licensed in Canada by Health
      Canada as of January 2011 and March 2012, respectively. Exsalt® wound dressing is "indicated
      for the management of partial and full thickens wounds such as decubitus ulcers, venous
      stasis ulcers, diabetic ulcers, 1st and 2nd degree burns, grafts and donor sites' or other
      acute or chronic wounds."

      3 Study Objectives & Purpose

      The purpose of this pilot study is to evaluate the effectiveness of the Exciton exsalt® Wound
      Dressings when combined with the DFCCP in patients with locally infected diabetic foot
      ulcers. The objective of the proposed work is twofold, namely 1) to quantify the
      effectiveness of exsalt® Wound Dressings on locally infected diabetic foot ulcers not
      progressing to healing under the current standard of care: evaluating IDSA wound
      classification, pain, wound size, and signs and symptoms of infection through a one-arm
      prospective repeated measures pilot study and 2) to compile subjective patient outcomes:
      satisfaction, perceived benefit, compliance. Evaluating the benefits of utilization of the
      Exciton exsalt® Wound Dressings when combined with the DFCCP.

      Specifically, the following work and objectives are proposed:

        1. A prospective, single-arm, repeated measures study to pilot the use of Exsalt® wound
           dressing in chronic wounds within an outpatient clinical setting; evaluate the benefits
           of utilization of exsalt® Wound Dressings within the DFCCPP.

        2. Repeated measures evaluating and reporting wound infection classification (IDSA), pain
           score, wound size, and key indicators of infection; pre and post-intervention.
           Quantifying the impact of the intervention to diabetic foot ulcer local infection,
           healing, and associated pain. Qualifying subjective patient outcomes including
           satisfaction, benefit, and compliance. Incidence of safety and adverse events will be
           reported within the scope of this pilot study.

      3.1 Research Questions

      The research proposed here is designed to address the following questions:

        1. What is the impact (monitoring key indicators of infection, wound size, and wound
           classification) of the application of the exsalt® Wound Dressing utilized as a primary
           dressing for up to four weeks in outpatients with diabetic foot ulcers that have a mild
           local infection and are non-responsive using standard-of-care.?

        2. What is the clinical utility of the use of the Exsalt® wound dressing from the
           perspective of clinical staff and patients?

        3. What are the benefits of utilization of the Exciton exsalt® Wound Dressings when
           combined with the DFCCP?

      4 Pilot Study Design

      4.1 Study type

      A prospective, single-arm, repeated measures study pilot study will be coordinated by the
      DON-SCN on the use of exsalt® Wound Dressings in mildly infected chronic diabetic foot ulcer
      wounds within three outpatient clinical settings; evaluating pre and post-intervention.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Infection assessed as per Infectious Disease Society of America (IDSA) guidelines
time frame: 28 days
description: Assessed as per Infectious Disease Society of America (IDSA) guidelines
measure: Pain assessed with Ordinal scale
time frame: 28 days
description: Ordinal scale, 0=none, 3=severe
measure: Wound volume
time frame: 28 days
description: Wound area multiplied by wound depth (cubic centimetres)
measure: Safety and complications (incidence of adverse events)
time frame: 28 days
description: The principal measure of safety will be the incidence of adverse events reported during the study. Adverse events from patients will be noted and thoroughly documented. Patients who experience adverse events may or may not be withdrawn from the study, depending on the nature and timing of the event; study investigators will review and assess each adverse event on a case-by-case basis. Data for safety assessments will be collected from all completed adverse events reports.
arm group label: Exciton
arm group type: Experimental
description: Treatment of diabetic foot ulcer with Exciton Exsalt wound dressing
intervention type: Device
intervention name: Exciton
description: Exsalt® Wound Dressings will be applied by the physician/nursing staff.
The test product, exsalt® Wound Dressings (0.4 mg Ag/cm2) will be applied after wound cleansing or debridement if required.
Dressings will be changed weekly, either at the out-patient facility or at home with provided dressings. At regular intervals throughout the study, as per the existing Diabetes Foot Care Clinical Care Pathway, wound assessment including size determination, Exsalt Wound Assessment Form, any adverse events will be reported, with tracing and/or photography included where available.
Maximum treatment course will be 28 days (end of study) or until wound closure.
arm group label: Exciton
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Alberta
investigator full name: Catherine Chan
investigator title: Professor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
sharing ipd: No