FoundationDRS Solo for Foot Ulcer

Overseen By Jerry Chang, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Samaritan Biologics

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

The potential subject must be willing and able to participate in the informed consent process.

My ulcer or limb had infections before, but they are now fully treated and under control.

Negative pregnancy test for females of childbearing potential. Females of childbearing potential must be willing to use acceptable methods of contraception starting at Screening and continuing through the duration of their study participation.

Exclusion Criteria

I do not have any major uncontrolled medical conditions like heart, kidney, liver, or lung disease.

The potential subject has a score of less than 17 and is considered malnourished according to the Mini Nutritional Assessment (MNA).

My diabetes is poorly controlled, with an HbA1c of 12.0 or higher.

What Are the Treatments Tested in This Trial?

Interventions

• FoundationDRS Solo

How Is the Trial Designed?

Group I: FoundationDRS Solo Experimental Treatment 2 Interventions

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

Group II: Standard of Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Samaritan Biologics

Lead Sponsor

Trials

2

Recruited

170+

Emergent Clinical Consulting, LLC

Industry Sponsor

Trials

6

Recruited

2,900+