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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. ;


Study Design


Related Conditions & MeSH terms


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

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