Clinical Trials in Japan / NCT06236750
Recruiting
Not applicable
Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds
NCT06236750 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Diabetic Foot UlcerVenous Leg Ulcer
Investigational drug(s) / intervention(s)
EPIFIX
EPIFIX: EPIFIX® is an allograft derived from dehydrated human amnion/chorion membrane. EPIFIX is a medical device in Japan (Generic name: Material using human amniotic membrane for promotion of tissue healing) for use on intractable ulcers that are non-responsive to existing therapies for the purpose of promoting wound healing.
Study 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
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.
Primary outcome measure(s)
- Efficacy Endpoint: Healing of Ulcers at 4 Weeks, 8 Weeks, and 12 Weeks — 4 weeks, 8 weeks, and 12 weeks after initial application
The percentage of patients to achieve wound closure at 4 weeks, 8 weeks, and 12 weeks after initial DHACM application, as a measure of healing rate. - Safety Endpoint: Incidence of Adverse Events — 9 months after initial application
Incidence rate of adverse events in DHACM-treated patients during 12 weeks of treatment and 6 months of follow-up.
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Kobe University Hospital | Kobe | Hyōgo | Recruiting |
| Saitame Medical University Hospital | Iruma-gun | Saitama | Recruiting |
| Juntendo University Hospital | Bunkyō-Ku | Tokyo | Recruiting |
| Kyorin University Hospital | Mitaka-shi | Tokyo | Recruiting |
| Tokyo Medical University Hospital | Shinjuku-Ku | Tokyo | Recruiting |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06236750 on ClinicalTrials.gov ↗ ← All trials in Japan