<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/NCT03037970</url>
  </required_header>
  <id_info>
    <org_study_id>Lynch 02-01</org_study_id>
    <nct_id>NCT03037970</nct_id>
  </id_info>
  <brief_title>Evaluation of ABSOLVE in Diabetic Foot Ulcers</brief_title>
  <acronym>ABSOLVE</acronym>
  <official_title>A Prospective Randomized Controlled Blinded Study to Evaluate the Safety and Efficacy of rhPDGF-BB Saturated Collagen Wound Dressings on Diabetic Foot Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lynch Biologics LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medelis Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centro Medico Militar</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lynch Biologics LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      ABSOLVE Biologic Wound Matrix is a combination of recombinant human platelet-derived growth&#xD;
      factor BB homodimer (rhPDGF-BB) and a bovine type I collagen wound dressing matrix. ABSOLVE&#xD;
      is under development for the treatment of chronic and acute wounds. This study investigates&#xD;
      the safety and efficacy of ABSOLVE in chronic diabetic foot ulcers (DFUs).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with diabetes are at risk for developing serious health problems that may affect the&#xD;
      feet, eyes, kidneys, skin and heart. Foot ulcerations are of great significance to the lives&#xD;
      of millions of diabetic patients, representing one of the most common and serious&#xD;
      complications in these patients. Up to 25% of diabetics will develop a diabetic foot ulcer&#xD;
      (DFU) at some point in their lifetime. The prevalence of DFUs among diabetics is 4% to 10%.&#xD;
      More than half of all foot ulcers will become infected requiring hospitalization and 1 in 5&#xD;
      will require amputation. Foot ulcers account for 85,000 non-trauma related lower limb&#xD;
      amputations annually in the USA. Every 20 seconds, somewhere in the world, a limb is lost as&#xD;
      a consequence of diabetes. Moreover, 85% of leg amputations are preceded by DFUs and more&#xD;
      than 60% of non-traumatic lower extremity amputations (LEA) performed in the United States&#xD;
      each year occurs secondary to complications of diabetes mellitus. After a major amputation,&#xD;
      50% of patients will have another limb amputated within two years. Mortality rates subsequent&#xD;
      to amputation are alarmingly high - up to 40% at 1 year and 80% at 5 years. Patients with a&#xD;
      history of a DFU have a 40% greater mortality rate compared to patients with diabetes alone.&#xD;
      Improved treatments for DFUs are clearly a matter of great significance.&#xD;
&#xD;
      In this study, the investigation will be focused on the safety and efficacy of ABSOLVE in&#xD;
      treating diabetic foot ulcers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">January 30, 2017</start_date>
  <completion_date type="Anticipated">October 15, 2017</completion_date>
  <primary_completion_date type="Anticipated">August 15, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is a randomized, blinded, two-arm, clinical study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>One component of the study drug will be blinded as the study employs a placebo-controlled arm. More specifically, vials containing rhPDGF or saline will be the same Type I, sodium borosilicate vials with rubber stopper, and plastic cap. Each vial will contain 3 ml of clear liquid. The vials will have blinded labels. Type I collagen wound dressings, on the other hand, will all be the same and are not part of the blinding.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)</measure>
    <time_frame>Week 0 - 24</time_frame>
    <description>Determine safety and tolerability of ABSOLVE on patients having a poorly healing diabetic foot ulcer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Successful wound healing for at least two consecutive measurements. (Efficacy)</measure>
    <time_frame>Week 12</time_frame>
    <description>Successfully healed wound must remain closed for at least two consecutive measurements, one of which will be at the 12-week examination.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wound Size</measure>
    <time_frame>Week 0 - 24</time_frame>
    <description>The percent change in wound size (closure) over time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound Closure</measure>
    <time_frame>Week 0 - 24</time_frame>
    <description>Percent incidence of complete wound closure over time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>Week 0 - 24</time_frame>
    <description>Reduction in complications.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Diabetic Foot Ulcers</condition>
  <arm_group>
    <arm_group_label>ABSOLVE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Type I collagen sheet soaked in a solution containing rhPDGF-BB.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Collagen sheet soaked with saline solution.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RhPDGF-BB</intervention_name>
    <description>One 2x4x.3cm of collagen wound matrix is saturated with 2.0 ml of the rhPDGF-BB solution.</description>
    <arm_group_label>ABSOLVE</arm_group_label>
    <other_name>ABSOLVE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Collagen Wound Dressing wetted with buffer.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults 30 to 75 years of age&#xD;
&#xD;
          -  A diagnosis of Type 1 or 2 diabetes with HbAlc between 6 and 12%, an adequate blood&#xD;
             supply defined as TcpO2 &gt; 30 mmHg or an ankle brachial index (ABI) ≥ 0.7 on the foot&#xD;
             with the target ulcer&#xD;
&#xD;
          -  A DFU 2 cm2-14 cm2 that extends into the subcutaneous tissues or beyond (≤Wagner Grade&#xD;
             2)&#xD;
&#xD;
          -  A DFU of at least 6 weeks duration and under care of the study investigator for at&#xD;
             least 2 weeks following standard wound debridement with less than 30% healing&#xD;
&#xD;
          -  Body Mass Index (BMI) of 18.5 to 40 kg/m2&#xD;
&#xD;
          -  Co-morbidities are under control and non-life threatening as determined by the&#xD;
             Investigator based on medical history, physical examination, vital signs, 12-lead ECG,&#xD;
             and clinical laboratory tests&#xD;
&#xD;
          -  A negative pregnancy test at Screening&#xD;
&#xD;
          -  Both males and WCBP agree to use acceptable contraceptive methods while on study&#xD;
&#xD;
          -  Able to comprehend and sign an ICF.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of clinically significant findings on screening evaluations (clinical,&#xD;
             laboratory, and ECG) which, in the opinion of the Investigator would pose a safety&#xD;
             risk or interfere with interpretation of safety data&#xD;
&#xD;
          -  Current or recent history of significant bacterial, fungal, viral, or mycobacterial&#xD;
             infection&#xD;
&#xD;
          -  History of malignancy, with the exception of cured basal cell or squamous cell&#xD;
             carcinoma of the skin&#xD;
&#xD;
          -  History of myocardial infarction, congestive heart failure, or stroke&#xD;
&#xD;
          -  History of psychotic disorder&#xD;
&#xD;
          -  History of alcoholism or drug addiction&#xD;
&#xD;
          -  Positive drug screen at Screening&#xD;
&#xD;
          -  Current treatment or treatment within 30 days prior to first dose of study products&#xD;
             with another investigational drug or current enrollment in another clinical trial&#xD;
&#xD;
          -  Known history of HIV, hepatitis B, or hepatitis C&#xD;
&#xD;
          -  Known hypersensitivity to any of the product's components&#xD;
&#xD;
          -  Subjects who are unable or unlikely to comply with the protocol&#xD;
&#xD;
          -  Pregnant or lactating.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luis Gonzalez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centro Medico Militar, Guatemala</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sam Lynch, DMSc, DMD</last_name>
    <phone>615-218-1624</phone>
    <email>sam.lynch@lynchbiologics.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Damon Michaels</last_name>
    <phone>615-724-4001</phone>
    <email>damon.michaels@medelis.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centro Medico Militar</name>
      <address>
        <city>Guatemala City</city>
        <zip>010116</zip>
        <country>Guatemala</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Guatemala</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>January 30, 2017</last_update_submitted>
  <last_update_submitted_qc>January 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2017</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>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Becaplermin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03037970
org study id: Lynch 02-01
nct id: NCT03037970
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
ABSOLVE Biologic Wound Matrix is a combination of recombinant human platelet-derived growth
      factor BB homodimer (rhPDGF-BB) and a bovine type I collagen wound dressing matrix. ABSOLVE
      is under development for the treatment of chronic and acute wounds. This study investigates
      the safety and efficacy of ABSOLVE in chronic diabetic foot ulcers (DFUs).
Patients with diabetes are at risk for developing serious health problems that may affect the
      feet, eyes, kidneys, skin and heart. Foot ulcerations are of great significance to the lives
      of millions of diabetic patients, representing one of the most common and serious
      complications in these patients. Up to 25% of diabetics will develop a diabetic foot ulcer
      (DFU) at some point in their lifetime. The prevalence of DFUs among diabetics is 4% to 10%.
      More than half of all foot ulcers will become infected requiring hospitalization and 1 in 5
      will require amputation. Foot ulcers account for 85,000 non-trauma related lower limb
      amputations annually in the USA. Every 20 seconds, somewhere in the world, a limb is lost as
      a consequence of diabetes. Moreover, 85% of leg amputations are preceded by DFUs and more
      than 60% of non-traumatic lower extremity amputations (LEA) performed in the United States
      each year occurs secondary to complications of diabetes mellitus. After a major amputation,
      50% of patients will have another limb amputated within two years. Mortality rates subsequent
      to amputation are alarmingly high - up to 40% at 1 year and 80% at 5 years. Patients with a
      history of a DFU have a 40% greater mortality rate compared to patients with diabetes alone.
      Improved treatments for DFUs are clearly a matter of great significance.

      In this study, the investigation will be focused on the safety and efficacy of ABSOLVE in
      treating diabetic foot ulcers.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a randomized, blinded, two-arm, clinical study
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: One component of the study drug will be blinded as the study employs a placebo-controlled arm. More specifically, vials containing rhPDGF or saline will be the same Type I, sodium borosilicate vials with rubber stopper, and plastic cap. Each vial will contain 3 ml of clear liquid. The vials will have blinded labels. Type I collagen wound dressings, on the other hand, will all be the same and are not part of the blinding.
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
time frame: Week 0 - 24
description: Determine safety and tolerability of ABSOLVE on patients having a poorly healing diabetic foot ulcer.
measure: Successful wound healing for at least two consecutive measurements. (Efficacy)
time frame: Week 12
description: Successfully healed wound must remain closed for at least two consecutive measurements, one of which will be at the 12-week examination.
measure: Wound Size
time frame: Week 0 - 24
description: The percent change in wound size (closure) over time.
measure: Wound Closure
time frame: Week 0 - 24
description: Percent incidence of complete wound closure over time.
measure: Complication rate
time frame: Week 0 - 24
description: Reduction in complications.
arm group label: ABSOLVE
arm group type: Experimental
description: Type I collagen sheet soaked in a solution containing rhPDGF-BB.
arm group label: Placebo
arm group type: Placebo Comparator
description: Collagen sheet soaked with saline solution.
intervention type: Drug
intervention name: RhPDGF-BB
description: One 2x4x.3cm of collagen wound matrix is saturated with 2.0 ml of the rhPDGF-BB solution.
arm group label: ABSOLVE
other name: ABSOLVE
intervention type: Other
intervention name: Placebo
description: Collagen Wound Dressing wetted with buffer.
arm group label: Placebo
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: No
last name: Luis Gonzalez, MD
role: Principal Investigator
affiliation: Centro Medico Militar, Guatemala
last name: Sam Lynch, DMSc, DMD
phone: 615-218-1624
email: sam.lynch@lynchbiologics.com
last name: Damon Michaels
phone: 615-724-4001
email: damon.michaels@medelis.com
facility: 
status: Recruiting
country: Guatemala
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer
mesh term: Becaplermin
sharing ipd: Undecided