<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/NCT01676272</url>
  </required_header>
  <id_info>
    <org_study_id>soluble 102</org_study_id>
    <nct_id>NCT01676272</nct_id>
  </id_info>
  <brief_title>Multi Center Site , Controlled Trial Comparing a Bioengineered Skin Substitute to a Human Skin Allograft</brief_title>
  <official_title>Proposal for a Multi- Center Site Randomized, Prospective Controlled Head-to-head Clinical Trial Comparing a Bioengineered Skin Substitute to a Human Skin Allograf</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Solsys Medical LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Solsys Medical LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite the widespread use of advanced biologics for the treatment of diabetic foot ulcers,&#xD;
      data comparing one type of modality to another are scarce. This investigation is a&#xD;
      prospective randomized study comparing a bioengineered skin substitute to a human skin&#xD;
      allograft.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary goal in treating a DFU is to obtain wound closure. Healing can be a lengthy and&#xD;
      painful process for ulcers of diabetic etiology. Healing is often further complicated in&#xD;
      subjects with diabetes by vascular compromise and peripheral ischemia, renal insufficiency&#xD;
      and diminution of inflammatory responses&#xD;
&#xD;
      The two products to be compared in this study are both commonly used for the treatment of&#xD;
      diabetic foot ulcers. DermaGraft is considered a medical device by the FDA, and was cleared&#xD;
      for the treatment of diabetic foot ulcers in 1997. It is a staple for the treatment of&#xD;
      diabetic foot ulcers, and is widely used throughout the United States. It is composed of an&#xD;
      absorbable substrate that has been seeded with living human fibroblasts. Once formed, the&#xD;
      graft is cryopreserved until it reaches the clinic, where it is defrosted and applied to the&#xD;
      wound surface.&#xD;
&#xD;
      TheraSkin is composed of a split thickness skin graft harvested within 24 hours post-mortem,&#xD;
      from an organ donor who has cleared the standard safety screenings. It is classified by the&#xD;
      FDA as a donated tissue. Once harvested, the graft is sanitized according to FDA&#xD;
      specifications, and cryopreserved, until it is delivered to the clinic for application to the&#xD;
      foot ulcer. It is also a widely used treatment for diabetic foot ulcers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proposal for a multi center site randomized, prospective controlled head-to-head clinical trial comparing a bioengineered skin substitute to a human skin allograft.</measure>
    <time_frame>2 years</time_frame>
    <description>Despite the widespread use of advanced biologics for the treatment of diabetic foot ulcers, data comparing one type of modality to another are scarce. This investigation is a prospective randomized study comparing a bioengineered skin substitute to a human skin allograft.</description>
  </primary_outcome>
  <enrollment type="Actual">23</enrollment>
  <condition>Diabetic Foot Ulcer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Study population includes Diabetic patients with type 1 or type 2 Diabetes with foot ulcers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:: Subjects are required to meet all of the following criteria for&#xD;
        enrollment into the study and subsequent randomization.&#xD;
&#xD;
          1. A signed and dated informed consent form has been obtained from the subject.&#xD;
&#xD;
          2. Subject is able and willing to comply with study procedures&#xD;
&#xD;
          3. Subject is male or female and is 18 years of age or older.&#xD;
&#xD;
          4. Subject, if female of childbearing potential, has a negative serum pregnancy test at&#xD;
             screening&#xD;
&#xD;
          5. Subject has type 1 or type 2 diabetes mellitus&#xD;
&#xD;
          6. Subject has glycosylated hemoglobin, HbA1c, less than or equal to 12%&#xD;
&#xD;
          7. Presence of at least one DFU that meets all of the following criteria:&#xD;
&#xD;
               1. Ulcer has been diagnosed as a full-thickness DFU and including those of the heel.&#xD;
&#xD;
               2. There is a minimum 2 cm margin between the qualifying study ulcer and any other&#xD;
                  ulcers on the specified foot, post-debridement)&#xD;
&#xD;
               3. Ulcer size (area) greater than 1 cm2 (post-debridement at time of randomization)&#xD;
                  not deeper than 5mm. deep. Ulcer size no larger than 10 cm2&#xD;
&#xD;
               4. Wagner grade 1 at initialization of the clinical trial&#xD;
&#xD;
               5. Duration of the study ulcer is at least 30 days at the time of the screening&#xD;
                  visit Note: If the subject has more than one qualifying DFU, the ulcer designated&#xD;
                  as the study ulcer will be at the discretion of the Investigator.&#xD;
&#xD;
          8. Subject has adequate vascular perfusion of the affected limb, as defined by at least&#xD;
             one of the following:&#xD;
&#xD;
               1. Ankle-Brachial Index (ABI) at least 0.65 (moderate arterial disease) and less&#xD;
                  than1.2&#xD;
&#xD;
               2. Toe pressure (plethysmography) &gt; 50 mm Hg&#xD;
&#xD;
               3. TcPO2 &gt; 40 mm Hg&#xD;
&#xD;
               4. Doppler ultrasound (biphasic or triphasic waveforms) consistent with adequate&#xD;
                  bloodflow to the affected extremity, as determined by the Investigator&#xD;
&#xD;
          9. Standard of Care practices of the Investigator and the site:&#xD;
&#xD;
        Subject or responsible caregiver is willing and able to maintain the required off-loading&#xD;
        (as applicable for the location of the ulcer) and applicable dressing changes.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:Subjects meeting any of the following criteria will be excluded from&#xD;
        enrollment and subsequent randomization.&#xD;
&#xD;
          1. Subject has suspected or confirmed signs/symptoms of gangrene or wound infection on&#xD;
             any part of the affected limb. (Subjects with wound infection at the screening visit&#xD;
             may be treated and re-screened for participation in the study after eradication of the&#xD;
             infection).&#xD;
&#xD;
          2. Subject has a history of hypersensitivity to bovine collagen and/or chondroitin, as&#xD;
             listed in the Dermagraft Directions for Use.&#xD;
&#xD;
          3. Subject has a history of hypersensitivity to any of the antibiotics or preservation&#xD;
             agents listed in the TheraSkin Instructions for Use.&#xD;
&#xD;
          4. Subject cannot be pregnant at the time of treatment.&#xD;
&#xD;
          5. Subject was previously treated under this clinical study protocol.&#xD;
&#xD;
          6. Subject has participated in another clinical trial involving a device or a&#xD;
             systemically administered investigational study drug/treatment within 30 days of&#xD;
             randomization visit.&#xD;
&#xD;
          7. Subject is currently receiving (i.e., within 30 days of randomization visit) or&#xD;
             scheduled to receive a medication or treatment which, in the opinion of the&#xD;
             Investigator, is known to interfere with or affect the rate and quality of wound&#xD;
             healing (e.g., systemic steroids, immunosuppressive therapy, autoimmune disease&#xD;
             therapy, cytostatic therapy within the 12 months prior to randomization, dialysis,&#xD;
             radiation therapy to the foot, vascular surgery, angioplasty or thrombolysis).&#xD;
&#xD;
          8. Subject has any of the following unstable conditions or circumstances that could&#xD;
             interfere with treatment regimen compliance:&#xD;
&#xD;
               1. Ability to perform required dressing changes&#xD;
&#xD;
               2. Ability to comply with treatment visit schedule&#xD;
&#xD;
               3. Mental incapacity&#xD;
&#xD;
               4. Current substance abuse&#xD;
&#xD;
          9. Subject has excessive lymphedema, which, in the opinion of the Investigator, could&#xD;
             interfere with wound healing.&#xD;
&#xD;
         10. Subject has unstable Charcot foot or Charcot with boney prominence that, in the&#xD;
             opinion of the Investigator, could inhibit wound healing.&#xD;
&#xD;
         11. Subject has ulcers secondary to a disease other than diabetes, e.g., vasculitis,&#xD;
             neoplasm's, or hematological disorders.&#xD;
&#xD;
         12. Subject has osteomyelitis with necrotic soft bone. (If the Investigator suspects the&#xD;
             presence of osteomyelitis, the diagnosis must be confirmed by plain film X-ray.)&#xD;
&#xD;
         13. Subject with Chopart amputation.&#xD;
&#xD;
         14. Subject has a history of bone cancer or metastatic disease on the affected limb,&#xD;
             radiation therapy to the foot or has had chemotherapy within the 12 months prior to&#xD;
             randomization.&#xD;
&#xD;
         15. Subject has been treated with wound dressings that include growth factors, engineered&#xD;
             tissues, or skin substitutes (e.g., Regranex®, Dermagraft®, Apligraf®,Theraskin®&#xD;
             GraftJacket®, OASIS®, Primatrix®, Matristem®,etc.) within 30 days of randomization.&#xD;
&#xD;
         16. Subject has been treated with hyperbaric oxygen within 5 days of screening.&#xD;
&#xD;
         17. Subject has a history of or any of the following current illnesses or conditions&#xD;
             (other than diabetes) that would compromise the safety of the subject, or the normal&#xD;
             wound healing process:&#xD;
&#xD;
               1. End-stage renal disease&#xD;
&#xD;
               2. Immunosuppression&#xD;
&#xD;
               3. Severe malnutrition&#xD;
&#xD;
               4. Liver disease&#xD;
&#xD;
               5. Aplastic anemia&#xD;
&#xD;
               6. Scleroderma&#xD;
&#xD;
               7. Acquired immune deficiency syndrome (AIDS) or HIV positive&#xD;
&#xD;
               8. Connective tissue disorder&#xD;
&#xD;
               9. Exacerbation of sickle cell anemia&#xD;
&#xD;
         18. Subject is an employee or relative of any member of the Investigational site or the&#xD;
             Sponsor.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nelson Keller, DPM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mary Immaculate Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington Hospital Wound Center</name>
      <address>
        <city>Washington</city>
        <state>Pennsylvania</state>
        <zip>15301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mary Immaculat Hospital Wound Care Center</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <zip>23602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>June 24, 2019</last_update_submitted>
  <last_update_submitted_qc>June 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2019</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>
  <!-- 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/NCT01676272
org study id: soluble 102
nct id: NCT01676272
lead sponsor: 
has dmc: No
Despite the widespread use of advanced biologics for the treatment of diabetic foot ulcers,
      data comparing one type of modality to another are scarce. This investigation is a
      prospective randomized study comparing a bioengineered skin substitute to a human skin
      allograft.
The primary goal in treating a DFU is to obtain wound closure. Healing can be a lengthy and
      painful process for ulcers of diabetic etiology. Healing is often further complicated in
      subjects with diabetes by vascular compromise and peripheral ischemia, renal insufficiency
      and diminution of inflammatory responses

      The two products to be compared in this study are both commonly used for the treatment of
      diabetic foot ulcers. DermaGraft is considered a medical device by the FDA, and was cleared
      for the treatment of diabetic foot ulcers in 1997. It is a staple for the treatment of
      diabetic foot ulcers, and is widely used throughout the United States. It is composed of an
      absorbable substrate that has been seeded with living human fibroblasts. Once formed, the
      graft is cryopreserved until it reaches the clinic, where it is defrosted and applied to the
      wound surface.

      TheraSkin is composed of a split thickness skin graft harvested within 24 hours post-mortem,
      from an organ donor who has cleared the standard safety screenings. It is classified by the
      FDA as a donated tissue. Once harvested, the graft is sanitized according to FDA
      specifications, and cryopreserved, until it is delivered to the clinic for application to the
      foot ulcer. It is also a widely used treatment for diabetic foot ulcers.
observational model: Cohort
time perspective: Prospective
measure: Proposal for a multi center site randomized, prospective controlled head-to-head clinical trial comparing a bioengineered skin substitute to a human skin allograft.
time frame: 2 years
description: Despite the widespread use of advanced biologics for the treatment of diabetic foot ulcers, data comparing one type of modality to another are scarce. This investigation is a prospective randomized study comparing a bioengineered skin substitute to a human skin allograft.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Nelson Keller, DPM
role: Principal Investigator
affiliation: Mary Immaculate Hospital
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer