Clinical trial NCT06236750: Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds
Official title: A Post-Marketing Surveillance to Observe the Safety and Efficacy of Dehydrated Human Amnion/Chorion Membrane (DHACM) Wound Graft in the Management of Non-Ischemic Chronic Wounds
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Venous Leg Ulcer
Lead sponsor: MiMedx Group, Inc.
Sponsor class: INDUSTRY
Collaborators: name: CMIC Co, Ltd. Japan
First posted: 2024-02-01
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy Endpoint: Healing of Ulcers at 4 Weeks, 8 Weeks, and 12 Weeks
timeFrame: 4 weeks, 8 weeks, and 12 weeks after initial application
measure: Safety Endpoint: Incidence of Adverse Events
timeFrame: 9 months after initial application
Secondary outcomes:
Other outcomes:
measure: Efficacy Endpoint: Reduction in Wound Size at 4 Weeks, 8 Weeks, and 12 Weeks
timeFrame: 4 weeks, 8 weeks, and 12 weeks after initial application
measure: Efficacy Endpoint: Time to Complete Wound Healing during 12 Weeks of Application
timeFrame: 12 weeks after initial application
measure: Efficacy Endpoint: Wound Recurrence for 6 months after Wound Closure
timeFrame: 6 months after wound closure
measure: Safety Endpoint: Incidence of Device Deficiencies
timeFrame: 9 months after initial application
Locations:
city: Kobe-shi
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Iruma-gun
country: Japan
facility: Saitame Medical University Hospital
state: Saitama
city: Bunkyō-Ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Mitaka-shi
country: Japan
facility: Kyorin University Hospital
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
Study officials:
affiliation: MiMedx Group, Inc.
name: David Mason, MD
role: STUDY_DIRECTOR
References: