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/NCT06028386</url>
    </required_header>
    <id_info>
      <org_study_id>CP-1003</org_study_id>
      <nct_id>NCT06028386</nct_id>
    </id_info>
    <brief_title>Use of AC5® Advanced Wound System in the Treatment of Diabetic Foot Ulcers</brief_title>
    <official_title>A Prospective Pilot Study Evaluating Wound Closure With the Application of AC5® Advanced Wound System in the Treatment of Diabetic Foot Ulcers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Arch Therapeutics</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Arch Therapeutics</source>
    <oversight_info>
      <has_dmc>No</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>
        The purpose of this clinical evaluation is to collect and compare outcomes data from patients&#xD;
        with UT 1A diabetic foot ulcers treated with 510K FDA cleared, commercially available&#xD;
        self-assembling peptide, AC5®Advanced Wound System, as compared to an advanced standard of&#xD;
        care. Patient outcomes will be compared at the end of the study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a prospective, multi-center randomized controlled study designed to collect&#xD;
        patient outcomes data for the treatment of diabetic foot ulcers. (DFU) All subjects will&#xD;
        receive standard of care procedures (SOC) such as wound cleaning, appropriate sharp&#xD;
        debridement, and appropriate offloading of the DFU (e.g., offloading Camboot or post op shoe&#xD;
        with offloading/wound care insole).&#xD;
  &#xD;
        Subjects will be randomized and receive treatments to either of the following arms:&#xD;
  &#xD;
        Arm 1 - Subject will receive SOC that will include AC5® Advanced Wound System as an active&#xD;
        synthetic cellular tissue product, covered with a non-adherent dressing plus an appropriate&#xD;
        outer dressing to maintain moisture balance, then wrapped with stretch gauze and&#xD;
        self-adherent wrap. AC5 will be applied weekly and outer dressings will be redressed, if&#xD;
        necessary, using the allowed secondary dressings.&#xD;
  &#xD;
        Arm 2 - Subject will receive SOC that will include Fibracol Plus collagen dressing as an&#xD;
        active dressing. This will be followed with an appropriate outer dressing to maintain&#xD;
        moisture balance, then wrapped with stretch gauze and self-adherent wrap as needed. Fibracol&#xD;
        Plus will be applied 3 x a week and any outer dressings will be redressed, if necessary,&#xD;
        using the allowed dressings.&#xD;
  &#xD;
        The study involves two phases: Screening and Treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 15, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
    <phase>N/A</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of wounds closed</measure>
      <time_frame>before or at 12 weeks</time_frame>
      <description>100% epithelialization</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in wound area size</measure>
      <time_frame>from randomization through to end of study (at 12 weeks) for non-closed wounds</time_frame>
      <description>Assess the percent change in wound area</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Days to complete wound closure</measure>
      <time_frame>before or at 12 weeks</time_frame>
      <description>median and mean</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of units used to achieve wound closure</measure>
      <time_frame>before or at 12 weeks</time_frame>
      <description>number of units used</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in quality of life</measure>
      <time_frame>before or at 12 weeks</time_frame>
      <description>Pain, odor, itch intensity and activities of daily living are assessed before any ulcer manipulations. Subject will fill out the quality of life form which utilizes a numeric scale from 0 (minimum) to indicate no pain, no odor, no itch, normal activities of daily living -10 (maximum) to indicate worst possible pain, extremely strong odor, worst possible itch and not able to perform activities of daily living.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Non-healing Wound</condition>
    <condition>Diabetic Foot Ulcer</condition>
    <arm_group>
      <arm_group_label>Arm 1-AC5® Advanced Wound System</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The intervention in this arm is the application of a synthetic self assembling peptide matrix (AC5) to UT Grade 1A diabetic foot ulcers</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm2- Fibracol Plus Collagen dressing</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>The intervention in this arm is the application of collagen dressings to UT Grade 1A diabetic foot ulcers</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>AC5® Advanced Wound System</intervention_name>
      <description>This group will receive AC5® Advanced Wound system, a synthetic self-assembling peptide matrix to the wound and covered with non-adherent dressing followed with appropriate outer dressing to maintain moisture balance. AC5 is applied weekly and outer dressing will be redressed as necessary.</description>
      <arm_group_label>Arm 1-AC5® Advanced Wound System</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Fibracol Plus Collagen Dressing</intervention_name>
      <description>This group will receive Fibracol Plus collagen dressing to the wound and covered with appropriate out dressing. Treatment will be done 3x a week.</description>
      <arm_group_label>Arm2- Fibracol Plus Collagen dressing</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Males and females aged 18 or older.&#xD;
  &#xD;
            2. Subject is willing to sign informed consent and participate in all procedures with&#xD;
               follow up evaluations as necessary to complete the study.&#xD;
  &#xD;
            3. Study ulcer is diabetic in origin, located on the foot or below the malleolus with&#xD;
               ulcer extending through the dermis but not into tendon, muscle or bone (UT Grade 1A).&#xD;
  &#xD;
            4. Study ulcer size is a minimum of 2 cm2 and maximum 25 cm2 after the run-in period.&#xD;
  &#xD;
            5. Study ulcer has been present for a minimum of 4 weeks before enrollment and less than&#xD;
               1 year old, with documented failure of prior treatment to heal the wound.&#xD;
  &#xD;
            6. Study ulcer has been offloaded for at least 14 days prior to randomization.&#xD;
  &#xD;
            7. A two-week run-in period will precede enrollment in the trial to document the indolent&#xD;
               nature of the subjects selected; healing rate is not to be &gt; 40% during this period.&#xD;
  &#xD;
            8. Subject does not exhibit clinical signs / symptoms of infection upon gross observation&#xD;
               or have been diagnosed with an active infection at time of screening.&#xD;
  &#xD;
            9. Subject has adequate control of diabetes demonstrated by Hemoglobin A1c &lt; 12% within&#xD;
               90 days of screening.&#xD;
  &#xD;
           10. Subject has adequate circulation to the affected extremity, as demonstrated by one of&#xD;
               the following within the past 60 days of the first screening visit:&#xD;
  &#xD;
                 -  Dorsal transcutaneous oxygen measurements (TCOM) ≥ 30mmHg.&#xD;
  &#xD;
                 -  Ankle-Brachial Index with results of ≥ 0.8 and ≤ 1.5 or had past intervention.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Study ulcer wound surface is area greater than 25 cm2.&#xD;
  &#xD;
            2. Study ulcer has &gt; 40% wound healing during the 14 days screening period.&#xD;
  &#xD;
            3. Subject has a known history of poor compliance with medical treatments.&#xD;
  &#xD;
            4. Subject is presently participating in another clinical trial.&#xD;
  &#xD;
            5. Subject has a known or suspected local malignancy to the Study diabetic ulcer, or&#xD;
               systemic malignancy.&#xD;
  &#xD;
            6. Subject has been diagnosed with autoimmune connective tissues diseases.&#xD;
  &#xD;
            7. Subject has received graft material or topical growth factors on the study ulcer&#xD;
               within the previous 30 days.&#xD;
  &#xD;
            8. Subject has received application of topical steroids on the study ulcer surface within&#xD;
               the previous 30 days.&#xD;
  &#xD;
            9. Subject is pregnant or breast feeding.&#xD;
  &#xD;
           10. Subject is on dialysis.&#xD;
  &#xD;
           11. Subject is taking medications that are considered immune system modulators or&#xD;
               cytotoxic chemotherapies.&#xD;
  &#xD;
           12. Subject cannot be on systemic antibiotics prior to randomization, however, during the&#xD;
               treatment phase infection management may include systemic antibiotics if in&#xD;
               conjunction with debridement.&#xD;
  &#xD;
           13. Subject has a known allergy to ingredients/components of AC5.&#xD;
  &#xD;
           14. Subject has osteomyelitis, and/or bony prominences present in the wound.&#xD;
  &#xD;
           15. Subject has ulcer probing to bone and tendon. (UT Grade II or III A-D).&#xD;
  &#xD;
           16. Subject is unable to comply with planned study procedures and treatments.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Brock Liden, DPM</last_name>
      <role>Principal Investigator</role>
      <affiliation>WAFL, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Evelyn Quintin</last_name>
      <phone>6174312308</phone>
      <email>equintin@archtherapeutics.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Terry Norchi, MD</last_name>
      <phone>800-937-9030</phone>
      <email>tnorchi@archtherapeutics.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Dr. Christopher Gauland</name>
        <address>
          <city>Greenville</city>
          <state>North Carolina</state>
          <zip>27834</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Christopher Gauland</last_name>
        <email>chris@ecfanc.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Dr. Brock Liden</name>
        <address>
          <city>Circleville</city>
          <state>Ohio</state>
          <zip>44113</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Brock Liden</last_name>
        <email>dpmresearch@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Warriner RA, Snyder RJ, Cardinal MH. Differentiating diabetic foot ulcers that are unlikely to heal by 12 weeks following achieving 50% percent area reduction at 4 weeks. Int Wound J. 2011 Dec;8(6):632-7. doi: 10.1111/j.1742-481X.2011.00860.x. Epub 2011 Sep 23.</citation>
      <PMID>21951763</PMID>
    </reference>
    <reference>
      <citation>Rahmani G, Prats J, Norchi T, Kates S, McInerney V, Woods J, Kelly J. First Safety and Performance Evaluation of T45K, a Self-Assembling Peptide Barrier Hemostatic Device, After Skin Lesion Excision. Dermatol Surg. 2018 Jul;44(7):939-948. doi: 10.1097/DSS.0000000000001468.</citation>
      <PMID>29381543</PMID>
    </reference>
    <reference>
      <citation>Koutsopoulos S. Self-assembling peptide nanofiber hydrogels in tissue engineering and regenerative medicine: Progress, design guidelines, and applications. J Biomed Mater Res A. 2016 Apr;104(4):1002-16. doi: 10.1002/jbm.a.35638. Epub 2016 Jan 25.</citation>
      <PMID>26707893</PMID>
    </reference>
    <reference>
      <citation>Kapp D, Pfendler L, D'Oro L, Wolcott R. Early clinical performance of an adaptive self-assembling barrier scaffold in nonhealing chronic wounds: a review of six cases. Wounds. 2022 Jan;33(1):20-30. doi: 10.25270/wnds/2022.2030.</citation>
      <PMID>35108216</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>DFU</keyword>
    <keyword>self-assembling peptide</keyword>
    <keyword>chronic wounds</keyword>
    <keyword>Synthetic matrix</keyword>
    <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>
      <mesh_term>Ulcer</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06028386
  org study id: CP-1003
  nct id: NCT06028386
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The purpose of this clinical evaluation is to collect and compare outcomes data from patients
        with UT 1A diabetic foot ulcers treated with 510K FDA cleared, commercially available
        self-assembling peptide, AC5®Advanced Wound System, as compared to an advanced standard of
        care. Patient outcomes will be compared at the end of the study.
  This study is a prospective, multi-center randomized controlled study designed to collect
        patient outcomes data for the treatment of diabetic foot ulcers. (DFU) All subjects will
        receive standard of care procedures (SOC) such as wound cleaning, appropriate sharp
        debridement, and appropriate offloading of the DFU (e.g., offloading Camboot or post op shoe
        with offloading/wound care insole).
  
        Subjects will be randomized and receive treatments to either of the following arms:
  
        Arm 1 - Subject will receive SOC that will include AC5® Advanced Wound System as an active
        synthetic cellular tissue product, covered with a non-adherent dressing plus an appropriate
        outer dressing to maintain moisture balance, then wrapped with stretch gauze and
        self-adherent wrap. AC5 will be applied weekly and outer dressings will be redressed, if
        necessary, using the allowed secondary dressings.
  
        Arm 2 - Subject will receive SOC that will include Fibracol Plus collagen dressing as an
        active dressing. This will be followed with an appropriate outer dressing to maintain
        moisture balance, then wrapped with stretch gauze and self-adherent wrap as needed. Fibracol
        Plus will be applied 3 x a week and any outer dressings will be redressed, if necessary,
        using the allowed dressings.
  
        The study involves two phases: Screening and Treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Percentage of wounds closed
  time frame: before or at 12 weeks
  description: 100% epithelialization
  measure: Change in wound area size
  time frame: from randomization through to end of study (at 12 weeks) for non-closed wounds
  description: Assess the percent change in wound area
  measure: Days to complete wound closure
  time frame: before or at 12 weeks
  description: median and mean
  measure: Number of units used to achieve wound closure
  time frame: before or at 12 weeks
  description: number of units used
  measure: Changes in quality of life
  time frame: before or at 12 weeks
  description: Pain, odor, itch intensity and activities of daily living are assessed before any ulcer manipulations. Subject will fill out the quality of life form which utilizes a numeric scale from 0 (minimum) to indicate no pain, no odor, no itch, normal activities of daily living -10 (maximum) to indicate worst possible pain, extremely strong odor, worst possible itch and not able to perform activities of daily living.
  arm group label: Arm 1-AC5® Advanced Wound System
  arm group type: Active Comparator
  description: The intervention in this arm is the application of a synthetic self assembling peptide matrix (AC5) to UT Grade 1A diabetic foot ulcers
  arm group label: Arm2- Fibracol Plus Collagen dressing
  arm group type: Placebo Comparator
  description: The intervention in this arm is the application of collagen dressings to UT Grade 1A diabetic foot ulcers
  intervention type: Device
  intervention name: AC5® Advanced Wound System
  description: This group will receive AC5® Advanced Wound system, a synthetic self-assembling peptide matrix to the wound and covered with non-adherent dressing followed with appropriate outer dressing to maintain moisture balance. AC5 is applied weekly and outer dressing will be redressed as necessary.
  arm group label: Arm 1-AC5® Advanced Wound System
  intervention type: Device
  intervention name: Fibracol Plus Collagen Dressing
  description: This group will receive Fibracol Plus collagen dressing to the wound and covered with appropriate out dressing. Treatment will be done 3x a week.
  arm group label: Arm2- Fibracol Plus Collagen dressing
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Brock Liden, DPM
  role: Principal Investigator
  affiliation: WAFL, Inc.
  last name: Evelyn Quintin
  phone: 6174312308
  email: equintin@archtherapeutics.com
  last name: Terry Norchi, MD
  phone: 800-937-9030
  email: tnorchi@archtherapeutics.com
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  citation: Warriner RA, Snyder RJ, Cardinal MH. Differentiating diabetic foot ulcers that are unlikely to heal by 12 weeks following achieving 50% percent area reduction at 4 weeks. Int Wound J. 2011 Dec;8(6):632-7. doi: 10.1111/j.1742-481X.2011.00860.x. Epub 2011 Sep 23.
  PMID: 21951763
  citation: Rahmani G, Prats J, Norchi T, Kates S, McInerney V, Woods J, Kelly J. First Safety and Performance Evaluation of T45K, a Self-Assembling Peptide Barrier Hemostatic Device, After Skin Lesion Excision. Dermatol Surg. 2018 Jul;44(7):939-948. doi: 10.1097/DSS.0000000000001468.
  PMID: 29381543
  citation: Koutsopoulos S. Self-assembling peptide nanofiber hydrogels in tissue engineering and regenerative medicine: Progress, design guidelines, and applications. J Biomed Mater Res A. 2016 Apr;104(4):1002-16. doi: 10.1002/jbm.a.35638. Epub 2016 Jan 25.
  PMID: 26707893
  citation: Kapp D, Pfendler L, D'Oro L, Wolcott R. Early clinical performance of an adaptive self-assembling barrier scaffold in nonhealing chronic wounds: a review of six cases. Wounds. 2022 Jan;33(1):20-30. doi: 10.25270/wnds/2022.2030.
  PMID: 35108216
  responsible party type: Sponsor
  mesh term: Diabetic Foot
  mesh term: Foot Ulcer
  mesh term: Ulcer
  mesh term: Wounds and Injuries
  sharing ipd: No