RecruitingPathologic ProcessesDiabetes MellitusGlucose Metabolism Disorders
Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) over 12 weeks using a modified platform trial design.
Sponsor: C5 Biomedical
You may qualify if…
- ✓ 1. At least 18 years of age or older.
- ✓ 2. Must have diagnosis of type 1 or 2 Diabetes mellitus.
- ✓ 3. At enrollment, subject must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with the imaging device.
- ✓ 4. Must have a target ulcer that has been present for a minimum of 4 weeks and maximum of 52 weeks of standard of care, prior to screening visit.
- ✓ 5. Target ulcer located on the foot with at least 50% of the ulcer below the malleolus.
- ✓ 6. Target ulcer that is 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. Subject's 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. ABI between 0.7 and \<= 1.3
You may not qualify if…
- ✕ 1. Subject is known to have a life expectancy of \< 6 months.
- ✕ 2. Subject's target ulcer is not secondary to diabetes.
- ✕ 3. Target ulcer is infected or there is cellulitis in the surrounding skin.
- ✕ 4. Target ulcer exposes tendon or bone.
- ✕ 5. Evidence of osteomyelitis complicating the target ulcer.
- ✕ 6. Infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
- ✕ 7. The 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. Subject is taking hydroxyurea.
Where it's recruiting
Louisiana
Metairie
Source: ClinicalTrials.gov · NCT06674980 · last updated 2024-12-27