RecruitingDiabetic Foot Ulcer (DFU)Ulcer FootDiabetic Foot
Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs
Eligible age
18+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
See if you qualify for this study
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About this study
The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal diabetic foot ulcers over 12 weeks using a modified platform trial design.
Sponsor: StimLabs
You may qualify if…
- ✓ 1. At least 18 years of age or older.
- ✓ 2. Diagnosis of type 1 or 2 Diabetes mellitus.
- ✓ 3. At enrollment, target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 25.0 cm2 measured post debridement with the MolecuLight® Imaging Device.
- ✓ 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 full thickness without exposed 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
Source: ClinicalTrials.gov · NCT06449638 · last updated 2026-03-02