NCT06444906

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

A Two-Part, Randomized Study of Dermacyte® Amniotic Wound Care Matrix for the Treatment of Diabetic Foot Ulcers (DFU)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Merakris Therapeutics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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 SOC.

Detailed 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.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	Dermacyte Matrix	The appropriate square centimeters of Dermacyte Matrix is applied directly to the target DFU that is free of debris and necrotic tissue. The Dermacyte Matrix will be applied at weekly intervals or for up to 10 applications.
OTHER	Standard of Care (SOC)	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 at weekly intervals or for up to 10 applications.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2024-06-06
• Last updated: 2024-06-10

Regulatory

• FDA-regulated device study