Modified Platform Trial Evaluating PpLHACM and SOC Versus SOC Alone in the Treatment of Nonhealing DFUs

Part of paid clinical trials in Monroeville, Pennsylvania.

Sponsor
MiMedx Group, Inc.
Study ID
NCT06600724
Status
Recruiting
Apply to this trial

Conditions

  • Diabetic Foot
  • Diabetic Foot Ulcer
  • Foot Ulcer
  • Foot Ulcer Due to Type 2 Diabetes Mellitus
  • Foot Ulcer, Diabetic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard of Care — OTHER
    Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
  • EPIEFFECT — OTHER
    Participants will receive weekly applications of EPIEFFECT and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first
  • EPIXPRESS — OTHER
    Participants will receive weekly applications of EPIXPRESS and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first

Study Details

This study will evaluate two human amnion/chorion membrane (ppLHACM) products and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).

Key Dates

Start date
Aug 27, 2024
Status verified
Sep 2024
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of Care
    Standard of care will be cleaning, debridement, ulcer moisture balance, and offloading.
  • Experimental: EPIEFFECT
    EPIEFFECT® is a PURION processed lyophilized human placental tissue allograft that includes the amnion layer, intermediate layer, and chorion layer of the amniotic membrane. The product is intended for use as a barrier to provide a protective environment in acute and chronic wounds.
  • Experimental: EPIXPRESS
    EPIXPRESS™ is a PURION processed lyophilized human placental tissue allograft that includes the amnion layer, intermediate layer, and chorion layer of the amniotic membrane. The product is intended for use as a barrier to provide a protective environment in acute and chronic wounds. EPIXPRESS is fenestrated to help facilitate fluid movement and can be used on wounds that produce copious amounts of exudate.

Primary Outcome Measure

Percentage of target ulcers achieving wound closure [ Time Frame: 1 - 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
SerenaGroup - MonroevilleMonroevillePennsylvania15146
Laura Serena
[email protected]
412-212-0123

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By research site
SerenaGroup - Monroeville· Monroeville, PA

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