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

NCT02973893 | Unknown Phase 2

• 1 other identifier: VF00102
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 17

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.

Conditions

Ulcer; Leg Ulcer; Varicose Ulcer; Pathologic Processes; Skin Ulcer; Skin Diseases; Vascular Diseases; Cardiovascular Diseases

Keywords

Chronic Venous Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• The percentage reduction in the study ulcer area in each treatment group over the 12-week Treatment Phase.

  Patient's ulcers healing rate

  12-weeks

Secondary Outcomes (6)

• The proportion of patients with complete study ulcer closure within the 12-week Treatment Phase

  12-weeks

• Time to complete study ulcer closure within the 12-week Treatment Phase

  12-weeks

• 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

  12-weeks

• Time to clinically meaningful study ulcer pain reduction (33% reduction on VAS) within the 12-week Treatment Phase

  12-weeks

• Change in Quality-of-Life metrics Euro Quality-of-Life Questionnaire EQ-5D-5L

  Up to 24-weeks

Other Outcomes (1)

• The incidence of adverse events (AEs), including overall AEs, AEs related to the IP and study-ulcer-associated AEs.

  Up to 24-weeks

Study Arms (3)

Placebo plus Standard Care

PLACEBO COMPARATOR

Placebo plus Standard Care

Biological: Placebo

VF001-DP LD plus Standard Care

EXPERIMENTAL

VF001-DP (14 micrograms per treatment) and Standard Care (low dose \[LD\])

Biological: VF001-DP LD

VF001-DP HD plus Standard Care

EXPERIMENTAL

VF001-DP (140 micrograms per treatment) and Standard Care (high dose \[HD\])

Biological: VF001-DP HD

Interventions

Placebo BIOLOGICAL

Placebo

Placebo plus Standard Care

VF001-DP LD BIOLOGICAL

VF001-DP contains parts of normal vitronectin and Insulin-like growth factor 1 (IGF-I) combined in a single protein.

VF001-DP LD plus Standard Care

VF001-DP HD BIOLOGICAL

VF001-DP contains parts of normal vitronectin and Insulin-like growth factor 1 (IGF-I) combined in a single protein.

VF001-DP HD plus Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old.
• 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).
• 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.
• 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.
• 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.
• 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:
• (a) 2.5 cm2 to not-more-than 5 cm2 and not-less-than 6 months or;
• (b) Not-less-than 5 cm2 to not-more-than 15 cm2 and not-more-than 6 months
• Ulcer with a clean, granulating base free of adherent slough at the T1 visit (post-debridement).
• 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.
• Patient able to understand the study procedures and willing to participate in the clinical study and able to comply with study visit schedule.
• Provide signed informed consent.

You may not qualify if:

• 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.
• 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.
• 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.
• Known allergy to any of the protocol-stipulated treatment procedures, or non-tolerance of multi-layer compression therapy.
• Ulcer which has undergone continuing high level of compression therapy for ≥12 months
• Ulcer, which in the opinion of the Investigator is suspicious for cancer.
• 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.
• IGF-1 treatment or treatment with a product containing IGF-1.
• Treatment with Pentoxifylline (Trental®) within 30-days of S1 visit.
• 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.
• 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.
• History of radiation at the ulcer site.
• 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.
• Known history of having Acquired Immunodeficiency Syndrome (AIDS) or with a history of known infection with Human Immunodeficiency Virus (HIV).
• Previous participation in any VF001-DP study within the past 6 months.

Sponsors & Collaborators

• Factor Therapeutics Ltd.: lead
• Parexel: collaborator
• ARANZ Medical: collaborator
• ALMAC Clinical Services: collaborator

Study Sites (17)

ILD Research Center

Carlsbad, California, 92130, United States

Location

Limb Preservation Platform, Inc.

Fresno, California, 93721, United States

Location

Alliance Research Centers

Laguna Hills, California, 24012, United States

Location

Foot and Ankle Clinic

Los Angeles, California, 90057, United States

Location

Center for Clinical Research

Martinez, California, 94553, United States

Location

Sacramento Foot Ankle Cente

Sacramento, California, 95628, United States

Location

Bay Area Foot Care

San Francisco, California, 94115, United States

Location

Bay Area Foot Care

San Francisco, California, 94705, United States

Location

NorthBay Center for Wound Care

Vacaville, California, 95687, United States

Location

University of Miami Hospital

Miami, Florida, 33136, United States

Location

Doctor Research Network (Dr Hanft)

Miami, Florida, 33143, United States

Location

Miami Dade Medical Research Center (Dr Oliva)

Miami, Florida, 33176, United States

Location

Spotlight Research Centre

Miami, Florida, 33176, United States

Location

Barry University School of Podiatric Medicine

North Miami Beach, Florida, 33169, United States

Location

Advanced Foot and Ankle Center

Las Vegas, Nevada, 89119, United States

Location

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Center for Advanced Wound Care PC

Wyomissing, Pennsylvania, 19610, United States

Location

MeSH Terms

Conditions

Ulcer; Leg Ulcer; Varicose Ulcer; Pathologic Processes; Skin Ulcer; Skin Diseases; Vascular Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Varicose Veins

Study Officials

• William Marston, MD

  UNC-Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 25, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: February 1, 2019
• Last Updated: September 25, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share

Locations

US (17)