A Two-Part, Randomized Study of Dermacyte® Amniotic Wound Care Matrix

Status Not yet recruiting

Clinical Trial Summary

Clinical Trial Description

This is a multi-center, prospective, two-part, controlled study to determine the percentage of participants with complete ulcer closure of a target DFU at Week 12 following treatment with Dermacyte Matrix or standard of care (SOC). Part 1 of the study will enroll 20 participants to determine the percentage of participants with a complete ulcer closure following treatment with Dermacyte Matrix at Week 12. In Part 2 of the study approximately 65 participants will be randomized 1:1 to receive Dermacyte Matrix or SOC for 12 weeks. The final sample size for Part 2 may be adjusted based on the effect size observed in Part 1 of the study. For the purposes of this study, SOC therapy will consist of debridement of nonviable tissue, saline-moistened non-occlusive dressing, weight off-loading to decrease pressure on extremity, aggressive treatment of infection and arterial revascularization if indicated. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06444906
Study type	Interventional
Source	Merakris Therapeutics
Contact	Travis C Jarrell, MS
Phone	301-905-6702
Email	tcjarrell@milestoneregualtory.com
Status	Not yet recruiting
Phase	N/A
Start date	September 1, 2024
Completion date	May 31, 2025

View Details

See also
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