RecruitingDiabetic Foot UlcerDFUDiabetic Foot Ulcer (DFU)
Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.
Sponsor: Sequence LifeScience, Inc.
You may qualify if…
- ✓ The potential subject must be at least 18 years of age or older.
- ✓ The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.
- ✓ At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 15.0 cm2 measured post debridement with the imaging device length times width.
- ✓ The potential subject must have a target ulcer that has been present for a minimum of 4 weeks of standard of care, prior to the initial screening visit.
- ✓ The potential subject must have a target ulcer located on the foot with at least 50% of the ulcer below the malleolus.
- ✓ The potential subject must have a 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.
- ✓ The potential 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…
- ✕ The potential subject is known to have a life expectancy of \< 6 months.
- ✕ The potential subject's target ulcer is not secondary to diabetes.
- ✕ The target ulcer is infected or there is cellulitis in the surrounding skin.
- ✕ The target ulcer exposes tendon or bone.
- ✕ There is evidence of osteomyelitis complicating the target ulcer.
- ✕ 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).
- ✕ The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
- ✕ The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
Where it's recruiting
Pennsylvania
Monroeville
Source: ClinicalTrials.gov · NCT07086443 · last updated 2026-05-19