Actively Recruiting
Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds
Led by MiMedx Group, Inc. · Updated on 2024-02-01
75
Participants Needed
5
Research Sites
178 weeks
Total Duration
On this page
Sponsors
M
MiMedx Group, Inc.
Lead Sponsor
C
CMIC Co, Ltd. Japan
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 wound cleaning, infection control, glycemic control, compression therapy, and moist dressings.
You will not qualify if you...
- Presence of active or latent infection in the ulcer area.
- Disorders causing intolerable risk of postoperative complications.
- Ulcers that cannot be sufficiently debrided.
- Ulcers with blood flow disorders leading to early wound bed necrosis after debridement.
- Wounds with multiple ulcer surfaces, exposed bone, and no blood flow in the wound bed.
- Hypersensitivity to aminoglycoside antibiotics used during manufacturing.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Kobe University Hospital
Kobe, Hyōgo, Japan, 650-0017
Actively Recruiting
2
Saitame Medical University Hospital
Iruma-gun, Saitama, Japan, 350-0495
Actively Recruiting
3
Juntendo University Hospital
Bunkyō-Ku, Tokyo, Japan, 113-8431
Actively Recruiting
4
Kyorin University Hospital
Mitaka-shi, Tokyo, Japan, 181-8611
Actively Recruiting
5
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo, Japan, 160-0023
Actively Recruiting
Research Team
C
Chief Medical Officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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