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

NARecruitingINTERVENTIONAL
Enrollment

170

Participants

Timeline

Start Date

August 27, 2024

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2026

Conditions
Diabetic Foot UlcerDiabetic FootFoot Ulcer Due to Type 2 Diabetes MellitusFoot Ulcer, DiabeticFoot 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

Trial Locations (1)

15146

RECRUITING

SerenaGroup - Monroeville, Monroeville

All Listed Sponsors
collaborator

SerenaGroup, Inc.

NETWORK

lead

MiMedx Group, Inc.

INDUSTRY