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

NCT07290673 | Not Yet Recruiting

• 1 other identifier: SB-25-1
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Foot Ulcer (DFU)

Keywords

Diabetes; Diabetic Foot; Allograft; Scaffold; Wound Healing; Advanced Wound Care; Comparative Effectiveness; Lower Extremity Ulcer; Time to heal; Treatment; Diabetes Complication; Skin Ulcer; Neuropathy; Peripheral artery disease; Ischemia; Wagner Grade

Outcome Measures

Primary Outcomes (1)

• Incidence of Complete Wound Closure

  The percentage of wounds completely healed. Complete healing will be defined as 100% epithelialization without drainage and need for dressing or wound size ≤ 0.1cm\^2 as determined by the site investigator and validated by a blinded review board.

  12-weeks following study screening phase

Secondary Outcomes (4)

• Time to wound closure

  12-weeks following study screening phase

• Percent reduction in wound area

  12-weeks following study screening phase

• Adverse Events

  12-weeks following study screening phase

• Wound Quality of life (Wound-QoL) questionnaire

  12-weeks following study screening phase

Other Outcomes (1)

• Proportion of ulcers that completely heal in patients 65 years or older

  12-weeks following study screening phase

Study Arms (2)

FoundationDRS Solo

EXPERIMENTAL

FoundationDRS Solo is a porous, degradable composite scaffold composed of chitosan and chondroitin sulfate

Other: FoundationDRS Solo; Other: Standard of Care

Standard of Care

ACTIVE COMPARATOR

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.

Other: Standard of Care

Interventions

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

FoundationDRS Solo; Standard of Care

FoundationDRS Solo OTHER

FoundationDRS Solo is a porous, degradable composite scaffold composed of chitosan and chondroitin sulfate

Also known as: Foundation DRS

FoundationDRS Solo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Samaritan Biologics: lead
• Emergent Clinical Consulting, LLC: collaborator

Study Sites (1)

Alma Medical and Research Services

Hollywood, Florida, 33021, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Leg Ulcer; Diabetes Complications; Skin Ulcer; Peripheral Arterial Disease; Ischemia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Jeremy J Mercuri, PhD

CONTACT

484-883-2033; jmercuri@samaritanbiologics.com

Jerry Chang, BS

CONTACT

352-256-2707; jchang@samaritanbiologics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study will be a multicenter, prospective, randomized design in which one treatment group will be compared to one control group.

Study Record Dates

• First Submitted: October 30, 2025
• First Posted: December 18, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)