Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EPIFIX.
- Who it may be relevant to
- Registry conditions: Diabetic Foot Ulcer, Venous Leg Ulcer. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Post-Marketing Surveillance to Observe the Safety and Efficacy of Dehydrated Human Amnion/Chorion Membrane (DHACM) Wound Graft in the Management of Non-Ischemic Chronic Wounds
Overview
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.
Detailed description
The study will enroll 75 subjects diagnosed with intractable diabetic foot ulcers or venous leg ulcers at 5 plastic surgery sites in Japan. Subjects will be treated with weekly applications of EPIFIX for up to 12 weeks, followed by 6 months of follow-up.
Interventions
- Device 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.
Primary outcome measures
- Efficacy Endpoint: Healing of Ulcers at 4 Weeks, 8 Weeks, and 12 Weeks [Time frame: 4 weeks, 8 weeks, and 12 weeks after initial application]
- Safety Endpoint: Incidence of Adverse Events [Time frame: 9 months after initial application]
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
- Areas of active infection or latent infection.
- Patients with disorders that would cause an intolerable risk of postoperative complications.
- Ulcers that cannot be sufficiently debrided.
- Ulcers that, after debridement, have blood flow disorders where wound bed necrosis progresses at an early stage.
- Wound surfaces with multiple ulcer surfaces and exposed bone, and no blood flow in the wound bed.
- Patients with hypersensitivity to the aminoglycoside antibiotics used during manufacturing.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 5 centers
- Kobe University Hospital — Kobe
- Saitame Medical University Hospital — Iruma-gun
- Juntendo University Hospital — Bunkyō-Ku
- Kyorin University Hospital — Mitaka-shi
- Tokyo Medical University Hospital — Shinjuku-Ku
Identifiers
NCT: NCT06236750 · EFJP001