Dermacyte® Amniotic Wound Care Liquid for the Treatment of Non-Healing Venous Stasis Ulcers

Venous Leg Ulcer Clinical Trial

Official title: A Two Part, Randomized Study of Dermacyte® Amniotic Wound Care Liquid for the Treatment of Non-Healing Venous Stasis Ulcers

Status Recruiting

Clinical Trial Summary

DL-VSU-201 is a randomized, double-blind, placebo controlled study in subjects with a non-infected venous stasis ulcer (VSU) that has failed to demonstrate improvement after receiving at least 4 weeks of standard, conventional wound therapy to evaluate the efficacy and safety of Dermacyte® Amniotic Wound Care Liquid (Dermacyte® Liquid).

Clinical Trial Description

DL-VSU-201 is a multi-center, two-part study in patients with VSU (n=40). The run-in phase of the study (Part 1) will enroll 10 eligible subjects. In part 1, patients will be randomized 1:1 to receive active Dermacyte once weekly or once every two weeks with standard of care. The data from Part 1 will be reviewed to determine the administration frequency of the study product (once weekly or once every two weeks) in Part 2 of the Study.

In Part 2, approximately 30 subjects will be randomized 1:1 to receive Dermacyte Liquid or placebo (0.9% NaCl) with standard of care. Subjects will be followed for 12 weeks.

Subjects will receive localized subcutaneous injection of Dermacyte® Liquid or placebo into and/or around the wound bed during during clinic visits over a 12-week period and assessed for safety and efficacy measures at Screening, Baseline, and Weeks 4, 8, and 12. Percent reduction of the wound surface area will be formally collected at Baseline, Weeks 4, 8, and

12. To assess healing, the ulcer will be evaluated by assessing the change in the surface area (L X W) from Baseline. Overall change in VAS from Baseline to Week 12 will be evaluated and total wound closure will be evaluated at Week 12. ;

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer
• Venous Stasis Ulcer

• NCT number: NCT04647240
• Study type: Interventional
• Source: Merakris Therapeutics
• Contact: Chris Broderick
• Phone: 919-921-8105
• Email: info@merakris.com
• Status: Recruiting
• Phase: Phase 2
• Start date: February 26, 2022
• Completion date: March 31, 2025