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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
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.
Kobe University Hospital
Kobe, Hyōgo, Japan
RECRUITINGSaitame Medical University Hospital
Iruma-gun, Saitama, Japan
RECRUITINGJuntendo University Hospital
Bunkyō-Ku, Tokyo, Japan
RECRUITINGEfficacy Endpoint: Healing of Ulcers at 4 Weeks, 8 Weeks, and 12 Weeks
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.
Time frame: 4 weeks, 8 weeks, and 12 weeks after initial application
Safety Endpoint: Incidence of Adverse Events
Incidence rate of adverse events in DHACM-treated patients during 12 weeks of treatment and 6 months of follow-up.
Time frame: 9 months after initial application
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Kyorin University Hospital
Mitaka-shi, Tokyo, Japan
RECRUITINGTokyo Medical University Hospital
Shinjuku-Ku, Tokyo, Japan
RECRUITING