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

NCT06600724 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2024-09-19

No results posted yet for this study

Summary

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).

Conditions

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

Interventions

OTHER

Standard of Care

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.

OTHER

EPIEFFECT

Participants will receive weekly applications of EPIEFFECT and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first

OTHER

EPIXPRESS

Participants will receive weekly applications of EPIXPRESS and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first

Sponsors & Collaborators

  • SerenaGroup, Inc.

    collaborator NETWORK

  • MiMedx Group, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Serena, MD · SerenaGroup, Inc.

  • Dennis McMahon, MD · MiMedx Group, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-27
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06600724 on ClinicalTrials.gov