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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Ulcer
- Sponsor
- Factor Therapeutics Ltd.
- Enrollment
- 156
- Locations
- 16
- Primary Endpoint
- The percentage reduction in the study ulcer area in each treatment group over the 12-week Treatment Phase.
- Last Updated
- 7 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •At least 18 years old.
- •Ankle-Brachial Pressure Index (ABI) ≥0.
- •(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:
- •1(a) 2.5 cm2 to not-more-than 5 cm2 and not-less-than 6 months or;
- •1(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).
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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 Outcomes
- Change in Quality-of-Life metrics Patient Benefit Index - wound version PBI-W(Up to 24-weeks)
- The proportion of patients with 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)
- Time to complete study ulcer closure 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)