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

Part of paid clinical trials in Hollywood, Florida.

Sponsor
Samaritan Biologics
Study ID
NCT07290673
Status
Not Yet Recruiting

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Conditions

  • Diabetic Foot Ulcer (DFU)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FoundationDRS Solo — OTHER
    FoundationDRS Solo is a porous, degradable composite scaffold composed of chitosan and chondroitin sulfate
  • Standard of Care — OTHER
    Standard of care (SOC) will include cleansing of the index wound with sterile normal saline solution, followed by sharp debridement to remove necrotic tissue, application of appropriate dressings and wound off-loading

Study Details

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 Dates

Start date
Apr 1, 2026
Status verified
Jan 2026
Primary completion
Oct 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
124 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: FoundationDRS Solo
    FoundationDRS Solo is a porous, degradable composite scaffold composed of chitosan and chondroitin sulfate
  • Active Comparator: Standard of Care
    Standard of care (SOC) will include cleansing of the index wound with sterile normal saline solution, followed by sharp debridement to remove necrotic tissue, application of appropriate dressings and wound off-loading.

Primary Outcome Measure

Incidence of Complete Wound Closure [ Time Frame: 12-weeks following study screening phase ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Alma Medical and Research ServicesHollywoodFlorida33021
Yadira Manso
[email protected]
305-631-5975

Find similar trials in Hollywood, FL

By research site
Alma Medical and Research Services· Hollywood, FL

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