Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds
← catalyst calendarNCT06236750 · readout ≤ 165 d
Sponsored by MiMedx Group, Inc. (industry) · MDXG — their whole pipeline →. With CMIC Co, Ltd. Japan.
Phase
Not applicable
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
75estimated
Sites
5
Country
Japan
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-08-04 | actual | When the study began enrolling |
| Primary completion | Jan 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jan 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2024-02-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2024-02-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Diabetic Foot Ulcer
- Venous Leg Ulcer
Intervention
- Device: EPIFIX — also filed as DHACM
Primary outcomes
what the primary-completion date above is the date OFEfficacy Endpoint: Healing of Ulcers at 4 Weeks, 8 Weeks, and 12 Weeks
measured 4 weeks, 8 weeks, and 12 weeks after initial application
Safety Endpoint: Incidence of Adverse Events
measured 9 months after initial application
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