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Study of VF001-DP in Patients With Chronic Venous Leg Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02973893
Recruitment Status : Unknown
Verified September 2018 by Factor Therapeutics Ltd..
Recruitment status was:  Active, not recruiting
First Posted : November 25, 2016
Last Update Posted : September 25, 2018
Sponsor:
Collaborators:
Parexel
ARANZ Medical
Almac Clinical Services LLC
Information provided by (Responsible Party):
Factor Therapeutics Ltd.

Brief Summary:
The purpose of this study is to determine if VF001-DP improves wound healing in chronic venous leg ulcers compared to standard care only.

Condition or disease Intervention/treatment Phase
Ulcer Leg Ulcer Varicose Ulcer Pathologic Processes Skin Ulcer Skin Diseases Vascular Diseases Cardiovascular Diseases Biological: Placebo Biological: VF001-DP LD Biological: VF001-DP HD Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo plus Standard Care
Placebo plus Standard Care
Biological: Placebo
Placebo

Experimental: VF001-DP LD plus Standard Care
VF001-DP (14 micrograms per treatment) and Standard Care (low dose [LD])
Biological: VF001-DP LD
VF001-DP contains parts of normal vitronectin and Insulin-like growth factor 1 (IGF-I) combined in a single protein.

Experimental: VF001-DP HD plus Standard Care
VF001-DP (140 micrograms per treatment) and Standard Care (high dose [HD])
Biological: VF001-DP HD
VF001-DP contains parts of normal vitronectin and Insulin-like growth factor 1 (IGF-I) combined in a single protein.




Primary Outcome Measures :
  1. The percentage reduction in the study ulcer area in each treatment group over the 12-week Treatment Phase. [ Time Frame: 12-weeks ]
    Patient's ulcers healing rate


Secondary Outcome Measures :
  1. The proportion of patients with complete study ulcer closure within the 12-week Treatment Phase [ Time Frame: 12-weeks ]
    How many patient's ulcers healed?

  2. Time to complete study ulcer closure within the 12-week Treatment Phase [ Time Frame: 12-weeks ]
    Time to Ulcer Healing

  3. 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 ]
    Measure of pain reduction to no pain

  4. Time to clinically meaningful study ulcer pain reduction (33% reduction on VAS) within the 12-week Treatment Phase [ Time Frame: 12-weeks ]
    Measure of meaningful pain reduction

  5. Change in Quality-of-Life metrics Euro Quality-of-Life Questionnaire EQ-5D-5L [ Time Frame: Up to 24-weeks ]
    Quality of life

  6. Change in Quality-of-Life metrics Patient Benefit Index - wound version PBI-W [ Time Frame: Up to 24-weeks ]
    Quality of life - specific to chronic wounds


Other Outcome Measures:
  1. 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 ]
    Safety



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. At least 18 years old.
  2. Ankle-Brachial Pressure Index (ABI) ≥0.80. (Calculations will be made using measurements from both posterior tibial and dorsalis pedis arteries as well as both arms).
  3. Presence of VLUs extending through the full thickness of the skin but not down to muscle, tendon or bone. In the case of more than one ulcer, the largest ulcer (compliant with study criteria) will be chosen as the study ulcer and treated in the study. Other ulcerations, if present on the same leg must be at least 2 cm apart from the study ulcer.
  4. Venous disease confirmed by Doppler ultrasonography to demonstrate reflux of >0.5 seconds in saphenous (great or small), calf perforators or the deep venous system. Patients with prior venous surgery (i.e., varicose vein stripping, endovenous ablation) may be included if they still demonstrate significant reflux in a remaining venous segment and the ulcer continues to suffer poor healing because of venous hypertension.
  5. Ulcer which has been present and treated with standard care (moisture retentive ulcer dressings and compression bandaging not limited to Mepitel® and Coban2®) for at least one month prior to the initial Screening Visit.
  6. Moderate severity ulcer at the T1 visit (post-debridement) complying with the following requirements of the Margolis Predictive Score Baseline Wound Area and Wound Duration:

    1. 1(a) 2.5 cm2 to not-more-than 5 cm2 and not-less-than 6 months or;
    2. 1(b) Not-less-than 5 cm2 to not-more-than 15 cm2 and not-more-than 6 months
  7. Ulcer with a clean, granulating base free of adherent slough at the T1 visit (post-debridement).
  8. Female patients of childbearing potential, willing to use acceptable methods of contraception (birth control pills, barriers, or sexual abstinence). A urine pregnancy test must be performed, and negative at the T1 visit.
  9. Patient able to understand the study procedures and willing to participate in the clinical study and able to comply with study visit schedule.
  10. Provide signed informed consent.

Exclusion Criteria

  1. Ulcer(s) deemed by the Investigator to be caused by a medical condition other than venous insufficiency. These may include, but are not limited to: fungal ulcerations, malignant ulcerations, diabetic (neuropathic) ulcerations, and ulcerations due to arterial insufficiency.
  2. Increase or decrease by >30% in the study ulcer surface area at the T1 visit post-debridement as compared to the S1 visit study ulcer surface area post-debridement.
  3. Ulcer exhibits clinical signs and symptoms of infection at S1to T1 in which case infection should be treated and the patient may after treatment be re-assessed for eligibility to enter into the study.
  4. Known allergy to any of the protocol-stipulated treatment procedures, or non-tolerance of multi-layer compression therapy.
  5. Ulcer which has undergone continuing high level of compression therapy for ≥12 months
  6. Ulcer, which in the opinion of the Investigator is suspicious for cancer.
  7. A history of more than 2 weeks' treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to initial screening, or treatments with such medications during the screening period, or anticipated requirement of such medications during the course of the study.
  8. IGF-1 treatment or treatment with a product containing IGF-1.
  9. Treatment with Pentoxifylline (Trental®) within 30-days of S1 visit.
  10. Treatment with any investigational drug(s) or therapeutic device(s) within 30 days preceding screening (i.e., S1); or anticipated (patient or physician anticipates) use of any of these therapies during the course of the study.
  11. Malignant disease not in remission for 5 years or more, other than basal cell carcinoma, squamous cell carcinoma of the skin or cervical carcinoma in situ, that have been successfully treated without evidence of recurrence or metastases.
  12. History of radiation at the ulcer site.
  13. As determined by medical history, presence of one or more medical conditions including renal, hepatic, hematologic, active auto-immune or immune diseases that, in the opinion of the Investigator, would make the patient an inappropriate candidate for this ulcer healing study.
  14. Known history of having Acquired Immunodeficiency Syndrome (AIDS) or with a history of known infection with Human Immunodeficiency Virus (HIV).
  15. Previous participation in any VF001-DP study within the past 6 months.
  16. Ulcer has been previously treated with tissue engineered materials (e.g., Apligraf® or Dermagraft®) or other scaffold materials (e.g., Oasis®, Matristem®) within the last 30 days prior to S1.
  17. Ulcer which in the opinion of the Investigator might require negative pressure ulcer therapy or hyperbaric oxygen during the course of the study.
  18. New York Heart Association Class III and IV congestive heart failure, as defined by the following criteria:

    1. Class III: Symptoms with moderate exertion
    2. Class IV: Symptoms at rest
  19. Uncontrolled diabetes mellitus, defined as Hemoglobin A1C >10% confirmed by the Investigator.
  20. Ulcer on the dorsum of the foot or with more than 50% of the ulcer below the malleolus is excluded.
  21. Known history of acromegaly.
  22. Any other medical or psychological condition (including relevant laboratory abnormalities at screening) that, in the opinion of the Investigator, may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study patient as a result of his/her participation in this clinical trial, may make patient's participation unreliable, or may interfere with study assessments. The specific justification for patients excluded under this criterion will be noted in study documents (chart notes, CRFs, etc).
  23. Women unwilling to use adequate birth control, if of reproductive potential and sexually active. Adequate birth control is defined as agreement to consistently practice an effective and accepted method of contraception throughout the duration of the study.
  24. Pregnancy or breast-feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973893


Locations
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United States, California
ILD Research Center
Carlsbad, California, United States, 92130
Limb Preservation Platform, Inc.
Fresno, California, United States, 93721
Alliance Research Centers
Laguna Hills, California, United States, 24012
Foot and Ankle Clinic
Los Angeles, California, United States, 90057
Center for Clinical Research
Martinez, California, United States, 94553
Sacramento Foot Ankle Cente
Sacramento, California, United States, 95628
Bay Area Foot Care
San Francisco, California, United States, 94115
Bay Area Foot Care
San Francisco, California, United States, 94705
NorthBay Center for Wound Care
Vacaville, California, United States, 95687
United States, Florida
University of Miami Hospital
Miami, Florida, United States, 33136
Doctor Research Network (Dr Hanft)
Miami, Florida, United States, 33143
Miami Dade Medical Research Center (Dr Oliva)
Miami, Florida, United States, 33176
Spotlight Research Centre
Miami, Florida, United States, 33176
Barry University School of Podiatric Medicine
North Miami Beach, Florida, United States, 33169
United States, Nevada
Advanced Foot and Ankle Center
Las Vegas, Nevada, United States, 89119
United States, North Carolina
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
Center for Advanced Wound Care PC
Wyomissing, Pennsylvania, United States, 19610
Sponsors and Collaborators
Factor Therapeutics Ltd.
Parexel
ARANZ Medical
Almac Clinical Services LLC
Investigators
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Principal Investigator: William Marston, MD UNC-Chapel Hill
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Responsible Party: Factor Therapeutics Ltd.
ClinicalTrials.gov Identifier: NCT02973893    
Other Study ID Numbers: VF00102
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Factor Therapeutics Ltd.:
Chronic Venous Leg Ulcer
Additional relevant MeSH terms:
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Cardiovascular Diseases
Vascular Diseases
Varicose Ulcer
Leg Ulcer
Skin Diseases
Skin Ulcer
Ulcer
Pathologic Processes
Varicose Veins