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

NCT06444906 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2024-06-10

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcer

Interventions

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.

Sponsors & Collaborators

  • Merakris Therapeutics

    lead INDUSTRY

Principal Investigators

  • Sean O'Connell, PhD · Consultant

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2025-05-31
Completion
2025-05-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06444906 on ClinicalTrials.gov