Diabetic Foot Ulcer, Venous Leg Ulcer
Conditions
Brief summary
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.
Detailed 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.
Interventions
DEVICEEPIFIX
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.
Sponsors
CMIC Co, Ltd. Japan
MiMedx Group, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint: Incidence of Adverse Events | 9 months after initial application | Incidence rate of adverse events in DHACM-treated patients during 12 weeks of treatment and 6 months of follow-up. |
| Efficacy Endpoint: Healing of Ulcers at 4 Weeks, 8 Weeks, and 12 Weeks | 4 weeks, 8 weeks, and 12 weeks after initial application | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Endpoint: Reduction in Wound Size at 4 Weeks, 8 Weeks, and 12 Weeks | 4 weeks, 8 weeks, and 12 weeks after initial application | 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. |
| Efficacy Endpoint: Time to Complete Wound Healing during 12 Weeks of Application | 12 weeks after initial application | The amount of time after initial DHACM application to achieve complete epithelialization of the wound. |
| Efficacy Endpoint: Wound Recurrence for 6 months after Wound Closure | 6 months after wound closure | The recurrence rate of healed ulcers will be monitored for 6 months after wound closure is achieved. |
| Safety Endpoint: Incidence of Device Deficiencies | 9 months after initial application | Incidence rate of device deficiencies, severity, and details in DHACM-treated patients during 12 weeks of treatment and 6 months of follow-up. |
Countries
Japan
Contacts
Primary ContactChief Medical Officer
Outcome results
None listed