Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds

Diabetic Foot Ulcer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06236750
• Other study ID #: EFJP001
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2023
• Est. completion date: January 2027

Study information

• Verified date: January 2024
• Source: MiMedx Group, Inc.
• Contact: Chief Medical Officer
• Phone: 770-651-9100
• Email: CTInquiries[@]mimedx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

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.

Locations

Country	Name	City	State
Japan	Juntendo University Hospital	Bunkyo-Ku	Tokyo
Japan	Saitame Medical University Hospital	Iruma-gun	Saitama
Japan	Kobe University Hospital	Kobe-shi	Hyogo
Japan	Kyorin University Hospital	Mitaka-shi	Tokyo
Japan	Tokyo Medical University Hospital	Shinjuku-Ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
MiMedx Group, Inc.	CMIC Co, Ltd. Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	4 weeks, 8 weeks, and 12 weeks after initial application
Other	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.	12 weeks after initial application
Other	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.	6 months after wound closure
Other	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.	9 months after initial application
Primary	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.	4 weeks, 8 weeks, and 12 weeks after initial application
Primary	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.	9 months after initial application