NCT06236750 Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds
| NCT ID | NCT06236750 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MiMedx Group, Inc. |
| Condition | Diabetic Foot Ulcer |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2023-08-04 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 75 participants in total. It began in 2023-08-04 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this survey is to observe the efficacy and safety of EPIFIX® dehydrated human amnion/chorion membrane (DHACM) for the treatment of intractable diabetic foot ulcers or venous leg ulcers.
Eligibility Criteria
Inclusion Criteria: Patients with intractable diabetic foot ulcers or venous leg ulcers that have not decreased in surface area by at least 50% after 4 weeks of conventional therapies, such as radical wound management (removal of necrotic tissue, infection control, wound cleansing, etc.), glycemic control for diabetic foot ulcers, compression therapy for venous stasis ulcers and moist therapy using wound dressing materials. Exclusion Criteria: 1. Areas of active infection or latent infection. 2. Patients with disorders that would cause an intolerable risk of postoperative complications. 3. Ulcers that cannot be sufficiently debrided. 4. Ulcers that, after debridement, have blood flow disorders where wound bed necrosis progresses at an early stage. 5. Wound surfaces with multiple ulcer surfaces and exposed bone, and no blood flow in the wound bed. 6. Patients with hypersensitivity to the aminoglycoside antibiotics used during manufacturing.
Contact & Investigator
David Mason, MD
STUDY DIRECTOR
MiMedx Group, Inc.
Frequently Asked Questions
Who can join the NCT06236750 clinical trial?
This trial is open to participants of all sexes, studying Diabetic Foot Ulcer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06236750 currently recruiting?
Yes, NCT06236750 is actively recruiting participants. Contact the research team at CTInquiries@mimedx.com for enrollment information.
Where is the NCT06236750 trial being conducted?
This trial is being conducted at Kobe, Japan, Iruma-gun, Japan, Bunkyō-Ku, Japan, Mitaka-shi, Japan and 1 additional location.
Who is sponsoring the NCT06236750 clinical trial?
NCT06236750 is sponsored by MiMedx Group, Inc.. The principal investigator is David Mason, MD at MiMedx Group, Inc.. The trial plans to enroll 75 participants.