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New treatment option for Diabetic Foot Ulcer
Official title Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds
ClinicalTrials.gov ID: NCT06236750
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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...
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Kobe, Hyōgo, Japan
- Iruma-gun, Saitama, Japan
- Bunkyō-Ku, Tokyo, Japan
- Mitaka-shi, Tokyo, Japan
- Shinjuku-Ku, Tokyo, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kobe, Hyōgo, Japan; Iruma-gun, Saitama, Japan; Bunkyō-Ku, Tokyo, Japan; Mitaka-shi, Tokyo, Japan; Shinjuku-Ku, Tokyo, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.