Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06600724

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

Led by MiMedx Group, Inc. · Updated on 2024-09-19

170

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

Sponsors

M

MiMedx Group, Inc.

Lead Sponsor

S

SerenaGroup, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years of age or older.
  • Diagnosis of type 1 or 2 Diabetes mellitus.
  • Target ulcer surface area between 0.7 cm² and 5.0 cm² after cleaning.
  • Ulcer present for at least 4 weeks and no more than 52 weeks under standard care before screening.
  • Ulcer located on the foot with at least half below the malleolus.
  • Ulcer classified as Wagner grade 1 or 2, involving dermis or subcutaneous tissue, possibly muscle below the medial malleolus, but no exposed tendon or bone.
  • Adequate blood flow in affected limb confirmed by specific vascular tests within 3 months.
  • If multiple ulcers, target ulcer must be largest and ulcers separated by at least 2 cm.
  • Plantar ulcers must be offloaded for at least 14 days before enrollment.
  • Consent to use prescribed offloading method throughout the study.
  • Agree to attend weekly study visits as required.
  • Willing and able to participate in informed consent process.
Not Eligible

You will not qualify if you...

  • Life expectancy less than 6 months.
  • Ulcer not caused by diabetes.
  • Infected target ulcer or cellulitis in surrounding skin.
  • Ulcer exposing tendon or bone.
  • Osteomyelitis complicating the ulcer.
  • Active infection requiring systemic antibiotics.
  • Use of immunosuppressants, cytotoxic chemotherapy, or medications interfering with wound healing.
  • Use of hydroxyurea.
  • Use of topical steroids on ulcer within one month before screening.
  • Previous partial amputation causing deformity that affects offloading.
  • Glycated hemoglobin (HbA1c) ≥ 12% within 3 months before screening.
  • Ulcer size reduced by more than 20% in the 2 weeks before screening or during the 2-week screening phase.
  • Acute or inactive Charcot foot affecting offloading.
  • Pregnant women or planning pregnancy within 6 months.
  • End stage renal disease requiring dialysis.
  • Participation in another clinical trial with investigational product within 30 days.
  • Medical or psychological conditions interfering with assessments.
  • Treatment with hyperbaric oxygen therapy or similar products within 30 days before screening.
  • Malnutrition score below 17 on Mini Nutritional Assessment.
  • Wounds with active or latent infection.
  • Disorders increasing risk of post-operative complications.
  • Sensitivity to aminoglycoside antibiotics.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

SerenaGroup - Monroeville

Monroeville, Pennsylvania, United States, 15146

Actively Recruiting

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Research Team

B

Brittany Bonafide

CONTACT

T

Thomas Serena, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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