Not Yet RecruitingNot Applicable

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

United States124 participantsStarted 2026-04-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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;

Exclusion criteria

What they're measuring

Incidence of Complete Wound Closure

Timeframe: 12-weeks following study screening phase

Trial details

NCT IDNCT07290673

SponsorSamaritan Biologics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-10-01

Contact for this trial

Jeremy J Mercuri, PhD

484-883-2033 jmercuri@samaritanbiologics.com

View on ClinicalTrials.gov More Diabetic Foot Ulcer (DFU) trials