A Prospective Randomized, Double-Blind, Placebo-Controlled Trial Comparing VitroGro® ECM to Placebo in Patients With Venous Leg Ulcers
|Venous Leg Ulcer||Drug: VitroGro® ECM Drug: Dulbecco's Phosphate Buffered Saline||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Prospective, Multi-Center, Randomized, Double Blind, Placebo-Controlled Trial Comparing Vitrogro® ECM To Placebo As An Adjunct To Standard Care In Patients With Venous Leg Ulcers|
- Time to complete wound closure within Treatment Phase [ Time Frame: 8 weeks ]
The primary efficacy endpoint for the study is the time to complete wound closure, within the 8-week Treatment Phase, as assessed by the investigator. Complete wound closure is defined as 100% re-epithelialization with no presence of scab or drainage as assessed by the Investigator at PH0 and confirmed at PH2.
The date of complete healing is defined as the date of the first assessment of complete closure (100% re-epithelialization with no presence of scab or drainage) when complete wound closure is confirmed at a study visit 14 days (±3 days) later. For the purposes of this study, the initial assessment of complete closure will occur at PH0 and complete closure will be confirmed at PH2.
- Percentage (%) change from baseline in ulcer surface area at the end of the Treatment Phase, as measured by SilhoutteStarTM [ Time Frame: 8 weeks ]
- Incidence of complete healing within Treatment Phase, as determined by Investigator assessment [ Time Frame: 8 weeks ]
- Incidence of complete healing at each visit within the 8-week Treatment Phase, as determined by Investigator assessment [ Time Frame: 8 weeks ]
- Percentage (%) surface area reduction from baseline, at each visit within the 8-week Treatment Phase, as measured by SilhoutteStarTM [ Time Frame: 8 weeks ]
- Time to first instance of no pain (i.e., pain score less than 5mm on VAS) [ Time Frame: 12 weeks ]
- Time to first instance when the patient expectation was met as assessed by Patient Benefit Index [ Time Frame: 12 weeks ]
- Incidence of ulcer recurrence, at the site of the ulcer, during the Post-Healing Phase [ Time Frame: Up to 4 weeks post-treatment ]
- Change in Quality of Life metrics at study end. [ Time Frame: 12 weeks ]
|Study Start Date:||January 2017|
|Estimated Study Completion Date:||June 2019|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
Active Comparator: VitroGro®ECM
A topical application of synthetic extracellular matrix (ECM) protein formulation to the wound bed) plus Standard Care (moisture retentive dressing and multi-layer compression therapy).
|Drug: VitroGro® ECM|
Placebo Comparator: Dulbecco's Phosphate Buffered Saline
Dulbecco's Phosphate Buffered Saline plus Standard Care (moisture retentive dressing and multi-layer compression therapy).
|Drug: Dulbecco's Phosphate Buffered Saline|