Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds

Launched by MIMEDX GROUP, INC. · Jan 24, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the use of a treatment called EPIFIX®, which is made from dehydrated human amnion/chorion membrane (DHACM), for patients with stubborn wounds like diabetic foot ulcers and venous leg ulcers. The main goal is to see how well this treatment works and whether it is safe for people whose wounds have not improved significantly after trying standard treatments for at least four weeks.

To be eligible for this study, participants should have chronic wounds that haven’t shrunk by at least half with typical care methods, which include cleaning the wound and managing blood sugar levels for diabetic patients. However, individuals with current infections in their wounds, certain health conditions that could complicate recovery, or specific types of wounds may not be able to participate. If someone joins the trial, they can expect to receive the EPIFIX® treatment and will be monitored for how well their wound heals. Overall, this study aims to explore a new option for people struggling with difficult-to-heal wounds.

Gender

ALL

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.