<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/NCT02973893</url>
  </required_header>
  <id_info>
    <org_study_id>VF00102</org_study_id>
    <nct_id>NCT02973893</nct_id>
  </id_info>
  <brief_title>Study of VF001-DP in Patients With Chronic Venous Leg Ulcers</brief_title>
  <official_title>A Prospective, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial Comparing Two Doses of VF001-DP to Placebo as an Adjunct to Standard Care in Patients With Chronic Venous Leg Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Factor Therapeutics Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Parexel</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>ARANZ Medical</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Almac Clinical Services LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Factor Therapeutics Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if VF001-DP improves wound healing in chronic&#xD;
      venous leg ulcers compared to standard care only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: The objective of this study is to demonstrate the effectiveness and safety of&#xD;
      VF001-DP as an adjunct to standard care (SC) in the treatment of chronic venous leg ulcers&#xD;
      (VLUs) compared to Placebo with SC over the course of the 12-week Treatment Phase.&#xD;
&#xD;
      Design: This study is a multi-center, randomized, double-blind, placebo-controlled&#xD;
      dose-response study designed to evaluate VF-001-DP as an adjunct to SC, versus Placebo and SC&#xD;
      in the treatment of chronic VLUs. The SC therapy for VLUs is a moisture retentive ulcer&#xD;
      dressing and multi-layer compression therapy. Mepitel® and Coban2® have been chosen to be&#xD;
      used as SC in this trial.&#xD;
&#xD;
      The study will have three (3) phases: Screening (2 weeks), Treatment Phase (12 weeks) and&#xD;
      Follow-Up (12 weeks).&#xD;
&#xD;
      Only patients whose study ulcer does not exhibit more than 30% change (increase or decrease)&#xD;
      in ulcer size post-debridement between Screening Phase Visit (S1) and Treatment Phase Visit&#xD;
      (T1) and who continue to meet eligibility criteria at T1 will be randomized to receive either&#xD;
      the Active Treatment group (VF001-DP low or high dose plus SC) or the Control Treatment group&#xD;
      (Placebo plus SC) in a ratio of 1:1:1.&#xD;
&#xD;
      Treatment: Eligible patients will be assigned to one of the following treatment groups:&#xD;
&#xD;
        -  Placebo and SC&#xD;
&#xD;
        -  VF001-DP (14 micrograms per treatment) and SC (low dose [LD])&#xD;
&#xD;
        -  VF001-DP (140 micrograms per treatment) and SC (high dose [HD]).&#xD;
&#xD;
      The investigational product (IP), i.e., VF001-DP and placebo, will be supplied in 1 mL&#xD;
      syringes each containing 0.5 mL of either VF001-DP or Placebo.&#xD;
&#xD;
      The IP contains parts of normal vitronectin and Insulin-like growth factor 1 (IGF-I) combined&#xD;
      in a single protein (vitronectin, amino acids 1-64 of the human sequence and IGF-I amino&#xD;
      acids 1-70 of the human sequence), 14 μg or 140 μg protein in 0.5 mL of Phosphate Buffered&#xD;
      Saline, pH 7.2. VF001-DP is manufactured utilizing an expression vector system in yeast to&#xD;
      Good Manufacturing Practice (GMP) and is not made with and does not include any products of&#xD;
      human or animal origin.&#xD;
&#xD;
      Number of Patients: It is planned to recruit 168 patients (56 per treatment group) at 26&#xD;
      centres in USA for this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Anticipated">February 2019</completion_date>
  <primary_completion_date type="Anticipated">November 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage reduction in the study ulcer area in each treatment group over the 12-week Treatment Phase.</measure>
    <time_frame>12-weeks</time_frame>
    <description>Patient's ulcers healing rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients with complete study ulcer closure within the 12-week Treatment Phase</measure>
    <time_frame>12-weeks</time_frame>
    <description>How many patient's ulcers healed?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to complete study ulcer closure within the 12-week Treatment Phase</measure>
    <time_frame>12-weeks</time_frame>
    <description>Time to Ulcer Healing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first instance of no study ulcer pain (i.e., pain score less than 5 mm on Visual Analog Scale [VAS]) within the 12-week Treatment Phase</measure>
    <time_frame>12-weeks</time_frame>
    <description>Measure of pain reduction to no pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to clinically meaningful study ulcer pain reduction (33% reduction on VAS) within the 12-week Treatment Phase</measure>
    <time_frame>12-weeks</time_frame>
    <description>Measure of meaningful pain reduction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality-of-Life metrics Euro Quality-of-Life Questionnaire EQ-5D-5L</measure>
    <time_frame>Up to 24-weeks</time_frame>
    <description>Quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality-of-Life metrics Patient Benefit Index - wound version PBI-W</measure>
    <time_frame>Up to 24-weeks</time_frame>
    <description>Quality of life - specific to chronic wounds</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The incidence of adverse events (AEs), including overall AEs, AEs related to the IP and study-ulcer-associated AEs.</measure>
    <time_frame>Up to 24-weeks</time_frame>
    <description>Safety</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">156</enrollment>
  <condition>Ulcer</condition>
  <condition>Leg Ulcer</condition>
  <condition>Varicose Ulcer</condition>
  <condition>Pathologic Processes</condition>
  <condition>Skin Ulcer</condition>
  <condition>Skin Diseases</condition>
  <condition>Vascular Diseases</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Placebo plus Standard Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo plus Standard Care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VF001-DP LD plus Standard Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VF001-DP (14 micrograms per treatment) and Standard Care (low dose [LD])</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VF001-DP HD plus Standard Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VF001-DP (140 micrograms per treatment) and Standard Care (high dose [HD])</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo plus Standard Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>VF001-DP LD</intervention_name>
    <description>VF001-DP contains parts of normal vitronectin and Insulin-like growth factor 1 (IGF-I) combined in a single protein.</description>
    <arm_group_label>VF001-DP LD plus Standard Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>VF001-DP HD</intervention_name>
    <description>VF001-DP contains parts of normal vitronectin and Insulin-like growth factor 1 (IGF-I) combined in a single protein.</description>
    <arm_group_label>VF001-DP HD plus Standard Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. At least 18 years old.&#xD;
&#xD;
          2. Ankle-Brachial Pressure Index (ABI) ≥0.80. (Calculations will be made using&#xD;
             measurements from both posterior tibial and dorsalis pedis arteries as well as both&#xD;
             arms).&#xD;
&#xD;
          3. Presence of VLUs extending through the full thickness of the skin but not down to&#xD;
             muscle, tendon or bone. In the case of more than one ulcer, the largest ulcer&#xD;
             (compliant with study criteria) will be chosen as the study ulcer and treated in the&#xD;
             study. Other ulcerations, if present on the same leg must be at least 2 cm apart from&#xD;
             the study ulcer.&#xD;
&#xD;
          4. Venous disease confirmed by Doppler ultrasonography to demonstrate reflux of &gt;0.5&#xD;
             seconds in saphenous (great or small), calf perforators or the deep venous system.&#xD;
             Patients with prior venous surgery (i.e., varicose vein stripping, endovenous&#xD;
             ablation) may be included if they still demonstrate significant reflux in a remaining&#xD;
             venous segment and the ulcer continues to suffer poor healing because of venous&#xD;
             hypertension.&#xD;
&#xD;
          5. Ulcer which has been present and treated with standard care (moisture retentive ulcer&#xD;
             dressings and compression bandaging not limited to Mepitel® and Coban2®) for at least&#xD;
             one month prior to the initial Screening Visit.&#xD;
&#xD;
          6. Moderate severity ulcer at the T1 visit (post-debridement) complying with the&#xD;
             following requirements of the Margolis Predictive Score Baseline Wound Area and Wound&#xD;
             Duration:&#xD;
&#xD;
               1. 1(a) 2.5 cm2 to not-more-than 5 cm2 and not-less-than 6 months or;&#xD;
&#xD;
               2. 1(b) Not-less-than 5 cm2 to not-more-than 15 cm2 and not-more-than 6 months&#xD;
&#xD;
          7. Ulcer with a clean, granulating base free of adherent slough at the T1 visit&#xD;
             (post-debridement).&#xD;
&#xD;
          8. Female patients of childbearing potential, willing to use acceptable methods of&#xD;
             contraception (birth control pills, barriers, or sexual abstinence). A urine pregnancy&#xD;
             test must be performed, and negative at the T1 visit.&#xD;
&#xD;
          9. Patient able to understand the study procedures and willing to participate in the&#xD;
             clinical study and able to comply with study visit schedule.&#xD;
&#xD;
         10. Provide signed informed consent.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Ulcer(s) deemed by the Investigator to be caused by a medical condition other than&#xD;
             venous insufficiency. These may include, but are not limited to: fungal ulcerations,&#xD;
             malignant ulcerations, diabetic (neuropathic) ulcerations, and ulcerations due to&#xD;
             arterial insufficiency.&#xD;
&#xD;
          2. Increase or decrease by &gt;30% in the study ulcer surface area at the T1 visit&#xD;
             post-debridement as compared to the S1 visit study ulcer surface area&#xD;
             post-debridement.&#xD;
&#xD;
          3. Ulcer exhibits clinical signs and symptoms of infection at S1to T1 in which case&#xD;
             infection should be treated and the patient may after treatment be re-assessed for&#xD;
             eligibility to enter into the study.&#xD;
&#xD;
          4. Known allergy to any of the protocol-stipulated treatment procedures, or non-tolerance&#xD;
             of multi-layer compression therapy.&#xD;
&#xD;
          5. Ulcer which has undergone continuing high level of compression therapy for ≥12 months&#xD;
&#xD;
          6. Ulcer, which in the opinion of the Investigator is suspicious for cancer.&#xD;
&#xD;
          7. A history of more than 2 weeks' treatment with immunosuppressants (including systemic&#xD;
             corticosteroids), cytotoxic chemotherapy, or application of topical steroids to the&#xD;
             ulcer surface within one month prior to initial screening, or treatments with such&#xD;
             medications during the screening period, or anticipated requirement of such&#xD;
             medications during the course of the study.&#xD;
&#xD;
          8. IGF-1 treatment or treatment with a product containing IGF-1.&#xD;
&#xD;
          9. Treatment with Pentoxifylline (Trental®) within 30-days of S1 visit.&#xD;
&#xD;
         10. Treatment with any investigational drug(s) or therapeutic device(s) within 30 days&#xD;
             preceding screening (i.e., S1); or anticipated (patient or physician anticipates) use&#xD;
             of any of these therapies during the course of the study.&#xD;
&#xD;
         11. Malignant disease not in remission for 5 years or more, other than basal cell&#xD;
             carcinoma, squamous cell carcinoma of the skin or cervical carcinoma in situ, that&#xD;
             have been successfully treated without evidence of recurrence or metastases.&#xD;
&#xD;
         12. History of radiation at the ulcer site.&#xD;
&#xD;
         13. As determined by medical history, presence of one or more medical conditions including&#xD;
             renal, hepatic, hematologic, active auto-immune or immune diseases that, in the&#xD;
             opinion of the Investigator, would make the patient an inappropriate candidate for&#xD;
             this ulcer healing study.&#xD;
&#xD;
         14. Known history of having Acquired Immunodeficiency Syndrome (AIDS) or with a history of&#xD;
             known infection with Human Immunodeficiency Virus (HIV).&#xD;
&#xD;
         15. Previous participation in any VF001-DP study within the past 6 months.&#xD;
&#xD;
         16. Ulcer has been previously treated with tissue engineered materials (e.g., Apligraf® or&#xD;
             Dermagraft®) or other scaffold materials (e.g., Oasis®, Matristem®) within the last 30&#xD;
             days prior to S1.&#xD;
&#xD;
         17. Ulcer which in the opinion of the Investigator might require negative pressure ulcer&#xD;
             therapy or hyperbaric oxygen during the course of the study.&#xD;
&#xD;
         18. New York Heart Association Class III and IV congestive heart failure, as defined by&#xD;
             the following criteria:&#xD;
&#xD;
               1. Class III: Symptoms with moderate exertion&#xD;
&#xD;
               2. Class IV: Symptoms at rest&#xD;
&#xD;
         19. Uncontrolled diabetes mellitus, defined as Hemoglobin A1C &gt;10% confirmed by the&#xD;
             Investigator.&#xD;
&#xD;
         20. Ulcer on the dorsum of the foot or with more than 50% of the ulcer below the malleolus&#xD;
             is excluded.&#xD;
&#xD;
         21. Known history of acromegaly.&#xD;
&#xD;
         22. Any other medical or psychological condition (including relevant laboratory&#xD;
             abnormalities at screening) that, in the opinion of the Investigator, may suggest a&#xD;
             new and/or insufficiently understood disease, may present an unreasonable risk to the&#xD;
             study patient as a result of his/her participation in this clinical trial, may make&#xD;
             patient's participation unreliable, or may interfere with study assessments. The&#xD;
             specific justification for patients excluded under this criterion will be noted in&#xD;
             study documents (chart notes, CRFs, etc).&#xD;
&#xD;
         23. Women unwilling to use adequate birth control, if of reproductive potential and&#xD;
             sexually active. Adequate birth control is defined as agreement to consistently&#xD;
             practice an effective and accepted method of contraception throughout the duration of&#xD;
             the study.&#xD;
&#xD;
         24. Pregnancy or breast-feeding.&#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>William Marston, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNC-Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ILD Research Center</name>
      <address>
        <city>Carlsbad</city>
        <state>California</state>
        <zip>92130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Limb Preservation Platform, Inc.</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93721</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance Research Centers</name>
      <address>
        <city>Laguna Hills</city>
        <state>California</state>
        <zip>24012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foot and Ankle Clinic</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Research</name>
      <address>
        <city>Martinez</city>
        <state>California</state>
        <zip>94553</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sacramento Foot Ankle Cente</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95628</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bay Area Foot Care</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bay Area Foot Care</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NorthBay Center for Wound Care</name>
      <address>
        <city>Vacaville</city>
        <state>California</state>
        <zip>95687</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Doctor Research Network (Dr Hanft)</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Dade Medical Research Center (Dr Oliva)</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spotlight Research Centre</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barry University School of Podiatric Medicine</name>
      <address>
        <city>North Miami Beach</city>
        <state>Florida</state>
        <zip>33169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Foot and Ankle Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina - Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Advanced Wound Care PC</name>
      <address>
        <city>Wyomissing</city>
        <state>Pennsylvania</state>
        <zip>19610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Puerto Rico</country>
  </removed_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>November 7, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>September 24, 2018</last_update_submitted>
  <last_update_submitted_qc>September 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Venous Leg Ulcer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Varicose Ulcer</mesh_term>
    <mesh_term>Leg Ulcer</mesh_term>
    <mesh_term>Skin Diseases</mesh_term>
    <mesh_term>Skin Ulcer</mesh_term>
    <mesh_term>Ulcer</mesh_term>
    <mesh_term>Pathologic Processes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT02973893
org study id: VF00102
nct id: NCT02973893
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to determine if VF001-DP improves wound healing in chronic
      venous leg ulcers compared to standard care only.
Objective: The objective of this study is to demonstrate the effectiveness and safety of
      VF001-DP as an adjunct to standard care (SC) in the treatment of chronic venous leg ulcers
      (VLUs) compared to Placebo with SC over the course of the 12-week Treatment Phase.

      Design: This study is a multi-center, randomized, double-blind, placebo-controlled
      dose-response study designed to evaluate VF-001-DP as an adjunct to SC, versus Placebo and SC
      in the treatment of chronic VLUs. The SC therapy for VLUs is a moisture retentive ulcer
      dressing and multi-layer compression therapy. Mepitel® and Coban2® have been chosen to be
      used as SC in this trial.

      The study will have three (3) phases: Screening (2 weeks), Treatment Phase (12 weeks) and
      Follow-Up (12 weeks).

      Only patients whose study ulcer does not exhibit more than 30% change (increase or decrease)
      in ulcer size post-debridement between Screening Phase Visit (S1) and Treatment Phase Visit
      (T1) and who continue to meet eligibility criteria at T1 will be randomized to receive either
      the Active Treatment group (VF001-DP low or high dose plus SC) or the Control Treatment group
      (Placebo plus SC) in a ratio of 1:1:1.

      Treatment: Eligible patients will be assigned to one of the following treatment groups:

        -  Placebo and SC

        -  VF001-DP (14 micrograms per treatment) and SC (low dose [LD])

        -  VF001-DP (140 micrograms per treatment) and SC (high dose [HD]).

      The investigational product (IP), i.e., VF001-DP and placebo, will be supplied in 1 mL
      syringes each containing 0.5 mL of either VF001-DP or Placebo.

      The IP contains parts of normal vitronectin and Insulin-like growth factor 1 (IGF-I) combined
      in a single protein (vitronectin, amino acids 1-64 of the human sequence and IGF-I amino
      acids 1-70 of the human sequence), 14 μg or 140 μg protein in 0.5 mL of Phosphate Buffered
      Saline, pH 7.2. VF001-DP is manufactured utilizing an expression vector system in yeast to
      Good Manufacturing Practice (GMP) and is not made with and does not include any products of
      human or animal origin.

      Number of Patients: It is planned to recruit 168 patients (56 per treatment group) at 26
      centres in USA for this study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The percentage reduction in the study ulcer area in each treatment group over the 12-week Treatment Phase.
time frame: 12-weeks
description: Patient's ulcers healing rate
measure: The proportion of patients with complete study ulcer closure within the 12-week Treatment Phase
time frame: 12-weeks
description: How many patient's ulcers healed?
measure: Time to complete study ulcer closure within the 12-week Treatment Phase
time frame: 12-weeks
description: Time to Ulcer Healing
measure: Time to first instance of no study ulcer pain (i.e., pain score less than 5 mm on Visual Analog Scale [VAS]) within the 12-week Treatment Phase
time frame: 12-weeks
description: Measure of pain reduction to no pain
measure: Time to clinically meaningful study ulcer pain reduction (33% reduction on VAS) within the 12-week Treatment Phase
time frame: 12-weeks
description: Measure of meaningful pain reduction
measure: Change in Quality-of-Life metrics Euro Quality-of-Life Questionnaire EQ-5D-5L
time frame: Up to 24-weeks
description: Quality of life
measure: Change in Quality-of-Life metrics Patient Benefit Index - wound version PBI-W
time frame: Up to 24-weeks
description: Quality of life - specific to chronic wounds
measure: The incidence of adverse events (AEs), including overall AEs, AEs related to the IP and study-ulcer-associated AEs.
time frame: Up to 24-weeks
description: Safety
arm group label: Placebo plus Standard Care
arm group type: Placebo Comparator
description: Placebo plus Standard Care
arm group label: VF001-DP LD plus Standard Care
arm group type: Experimental
description: VF001-DP (14 micrograms per treatment) and Standard Care (low dose [LD])
arm group label: VF001-DP HD plus Standard Care
arm group type: Experimental
description: VF001-DP (140 micrograms per treatment) and Standard Care (high dose [HD])
intervention type: Biological
intervention name: Placebo
description: Placebo
arm group label: Placebo plus Standard Care
intervention type: Biological
intervention name: VF001-DP LD
description: VF001-DP contains parts of normal vitronectin and Insulin-like growth factor 1 (IGF-I) combined in a single protein.
arm group label: VF001-DP LD plus Standard Care
intervention type: Biological
intervention name: VF001-DP HD
description: VF001-DP contains parts of normal vitronectin and Insulin-like growth factor 1 (IGF-I) combined in a single protein.
arm group label: VF001-DP HD plus Standard Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: William Marston, MD
role: Principal Investigator
affiliation: UNC-Chapel Hill
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country: United States
country: Puerto Rico
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Vascular Diseases
mesh term: Varicose Ulcer
mesh term: Leg Ulcer
mesh term: Skin Diseases
mesh term: Skin Ulcer
mesh term: Ulcer
mesh term: Pathologic Processes
sharing ipd: Yes