Evaluating the Efficacy of FoundationDRS Solo in Addition to Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers

Starting soon · Not applicable

Conditions studied: Diabetic Foot Ulcer (DFU)

In brief

The goal of this clinical trial is to learn if using FoundationDRS Solo improves healing of chronic, non-healing foot ulcers in diabetic patients. The main question that this study aims to answer is: Does FoundationDRS Solo, when used in conjunction with standard of care wound management techniques, result in a higher percentage of target ulcers achieving complete closure (i.e. healing) as compared to ulcers being treated with standard of care alone after 12 weeks of treatment. One ulcer on each participant's foot will receive weekly applications of 1) FoundationDRS Solo and standard of care wound management or 2) standard of care wound management alone. Pictures of the ulcer and measurements of its size will be measured every week to track its healing progress over a total treatment period of 12 weeks. Additionally, the participants will be asked to fill out a questionnaire about the wound impacts their life and their quality of life.

Key facts

Study ID

NCT07290673

Run by

Samaritan Biologics

People needed

124

Starts

2026-04-01

Expected to finish

2027-12-31

Last updated by the study team

2026-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Subjects must be at least 18 years of age or older.
• Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus requiring treatment with oral medications and/or insulin replacement therapy.
• At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement prior to randomization at treatment visit 1 (TV1).
• The target ulcer must have been present for a minimum of 4 weeks and is unresponsive (defined by less than 50% wound area reduction) to standard wound care.
• The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
• 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 either malleoli.
• 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:
• ABI between 0.7 and ≤ 1.3;
• TBI ≥ 0.6;
• TCOM ≥ 40 mmHg;
• PVR: biphasic;
• skin perfusion pressure (SPP) ≥ 30 mmHg.
• If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
• The index ulcer has been offloaded with protocol defined offloading device for at least 14 days prior to randomization (i.e. Screening through TV1/Randomization).
• 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.
• Index ulcer and/or index ulcer limb may have had prior infection(s), but must be adequately treated and controlled as defined by IDSA Guidelines Grade level 1 (Appendix L).
• The index ulcer has a clean base and is free from necrotic debris at time of placement of product / treatment.
• Negative pregnancy test for females of childbearing potential (e.g., not post-menopausal for at least one yar or surgically sterile). Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) starting at Screening and continuing through the duration of their study participation.

You may not qualify if…

• The target ulcer has been present for more than 52 weeks.
• The ulcer includes exposed tendon or bone.
• 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 has cellulitis in the surrounding skin.
• There is evidence of osteomyelitis complicating the target ulcer.
• The potential subject has 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.
• The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
• The potential subject has a previous partial amputation on the affected foot that resulted in a deformity impeding proper offloading of the target ulcer.
• A potential subject must be excluded if either of the following conditions are met:
• Condition A (Overall 4-week reduction)
• The surface are of the target ulcer has decreased by more than 50% over the 4 weeks prior to Treatment Visit 1, which includes:
• The historical run-in period, and
• The 2-week Screening Phase.
• OR
• Condition B (Sequential reductions across both phases)
• Both of the following are true:
• During the historical run-in period (the 2-weeks prior to the Screening Visit):
• The target ulcer surface area decreases by more than 25%.
• During the active 2-week Screening Phase (from Screening Visit 1 [SV1] to Treatment Visit 1 [TV1]):
• The target ulcer surface area decreases by an additional 25% or more.
• The surface area of the potential subject's target ulcer has reduced in size by more than 50% in the 4 weeks prior to Treatment Visit 1 (i.e. 2-week historical run-in and 2-week screening phase).
• The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
• The potential subject has an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer.

Where it is running

• Alma Medical and Research Services — Hollywood, Florida, United States

Full record on ClinicalTrials.gov

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