RecruitingDiabetic FootFoot UlcerUlcer Foot
A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
A multicenter, prospective, controlled clinical trial evaluating the efficacy of a single layer placental-based allograft and standard of care in the management of nonhealing diabetic foot ulcers.
Sponsor: Applied Biologics, LLC
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.
- ✓ If the potential subject has two or more ulcers, the target ulcer must be the same ulcer treated in the CAMPX study.
- ✓ The potential subject must consent to using the prescribed offloading method for the duration of the study.
- ✓ The potential subject must agree to attend the weekly study visits required by the protocol.
- ✓ The potential subject must be willing and able to participate in the informed consent process.
- ✓ The potential subject must have participated in the CAMPX trial in the SOC only arm and NOT achieved complete closure by the 12-week endpoint.
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.
- ✕ There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
- ✕ 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.
Where it's recruiting
Florida
Hollywood
Source: ClinicalTrials.gov · NCT07159282 · last updated 2026-02-11