An interventional study of EPIFIX in Diabetic Foot Ulcer and Venous Leg Ulcer, sponsored by MiMedx Group, Inc.. Recruiting at 5 sites in Japan. Per ClinicalTrials.gov, last updated 2024-02-01.
Sponsored by MiMedx Group, Inc. · Not applicable, Interventional, and Treatment
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.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 75 is above the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →MiMedx Group, Inc. is the lead sponsor of 35 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with intractable diabetic foot ulcer or venous leg ulcer that have not decreased in surface area by at least 50% after 4 weeks of conventional therapies.
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.
Also known as: DHACM
Efficacy 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
Efficacy Endpoint: Reduction in Wound Size at 4 Weeks, 8 Weeks, and 12 Weeks
Wound size will be measured at 4 weeks, 8 weeks, and 12 weeks after initial DHACM application, and the percent reduction of wound area will be calculated compared to baseline (week 0), as a measure of rate of wound closure.
Time frame: 4 weeks, 8 weeks, and 12 weeks after initial application
Efficacy Endpoint: Time to Complete Wound Healing during 12 Weeks of Application
The amount of time after initial DHACM application to achieve complete epithelialization of the wound.
Time frame: 12 weeks after initial application
Efficacy Endpoint: Wound Recurrence for 6 months after Wound Closure
The recurrence rate of healed ulcers will be monitored for 6 months after wound closure is achieved.
Time frame: 6 months after wound closure
Safety Endpoint: Incidence of Device Deficiencies
Incidence rate of device deficiencies, severity, and details 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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