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RecruitingDiabetic Foot UlcerDiabetic FootFoot Ulcer Due to Type 2 Diabetes Mellitus

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

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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).

Sponsor: MiMedx Group, Inc.

You may qualify if…

  • ✓ 1. At least 18 years of age or older.
  • ✓ 2. Diagnosis of type 1 or 2 Diabetes mellitus.
  • ✓ 3. At randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm\^2 and a maximum surface area of 5.0 cm\^2 measured post debridement.
  • ✓ 4. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.
  • ✓ 5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
  • ✓ 6. The target ulcer must be Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.
  • ✓ 7. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
  • ✓ 1. Ankle-Brachial Index (ABI) between 0.7 and ≤ 1.3;

You may not qualify if…

  • ✕ 1. The potential subject is known to have a life expectancy of \< 6 months.
  • ✕ 2. The potential subject's target ulcer is not secondary to diabetes.
  • ✕ 3. The target ulcer is infected or there is cellulitis in the surrounding skin.
  • ✕ 4. The target ulcer exposes tendon or bone.
  • ✕ 5. There is evidence of osteomyelitis complicating the target ulcer.
  • ✕ 6. There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
  • ✕ 7. The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
  • ✕ 8. The potential subject is taking hydroxyurea.

Where it's recruiting

Pennsylvania

Monroeville

Source: ClinicalTrials.gov · NCT06600724 · last updated 2024-09-19

Modified Platform Trial Evaluating PpLHACM and SOC Versus SOC Alone in · TrialPath