Study for Nonhealing Diabetic Foot Ulcers

This study is looking at new ways to help nonhealing diabetic foot ulcers (sores on the feet that don't heal well) close. It compares two products, EPIEFFECT and EPIXPRESS, which are both made from human amnion/chorion membrane (a type of tissue), along with standard care, against standard care alone. Standard care includes cleaning, removing dead tissue, keeping the wound moist, and taking pressure off the foot. You might be able to join if you are at least 18 years old, have type 1 or 2 diabetes, and have a foot ulcer that has been present for 4 to 52 weeks and is between 0.7 and 5.0 square centimeters in size. The main goal is to see what percentage of ulcers close within 1 to 12 weeks. The current recruitment status is unclear.

Study design
This study will compare two different treatments plus standard care against standard care alone. It plans to include 170 participants.
What's involved
Participants will receive weekly treatment with either standard care alone or standard care plus EPIEFFECT or EPIXPRESS until their ulcer closes, or for a maximum of 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for wound closure is measured between 1 and 12 weeks.

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NCT06600724

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

Recruiting
NAAges 18+InterventionalTreatment
MiMedx Group, Inc.
~170 participants
Updated 2024-09-19 on ClinicalTrials.gov
What's tested:Standard of CareEPIEFFECTEPIXPRESS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of target ulcers achieving wound closure
Measured over 1 - 12 weeks
Diabetic Foot Ulcer
Diabetic Foot
Foot Ulcer Due to Type 2 Diabetes Mellitus
Foot Ulcer, Diabetic
Foot Ulcer
1 sites across 1 states
Pennsylvania1
  • Thomas Serena, MD · PRINCIPAL_INVESTIGATOR · SerenaGroup, Inc.
  • Dennis McMahon, MD · STUDY_DIRECTOR · MiMedx Group, Inc.

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  • Percentage of target ulcers achieving wound closure1 - 12 weeks

    The percentage of target ulcers achieving complete wound closure in 12 weeks.