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.
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.
Eligibility
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:
1. Areas of active infection or latent infection.
2. Patients with disorders that would cause an intolerable risk of postoperative
complications.
3. Ulcers that cannot be sufficiently debrided.
4. Ulcers that, after debridement, have blood flow disorders where wound bed necrosis
progresses at an early stage.
5. Wound surfaces with multiple ulcer surfaces and exposed bone, and no blood flow in the
wound bed.
6. Patients with hypersensitivity to the aminoglycoside antibiotics used during
manufacturing.