Clinical trials

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Condition / disease
Location
Status: Not yet recruiting

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

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.

Participants needed: 124
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Samaritan BiologicsUpdated: Mar 9, 2026Locations: 1
Eligibility criteria

1. Subjects must be at least 18 years of age or older. [+11]

The index ulcer has been offloaded with protocol defined offloading device for a... [+16]

Status: Recruiting

Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers.

The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients. The main question that this study aims to answer is: Does the use of perinatal tissue allografts 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 1) applications of perinatal tissue allografts 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.

Participants needed: 170
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Samaritan BiologicsUpdated: May 13, 2025Locations: 1
Eligibility criteria

Subjects must be at least 18 years of age or older. [+10]

Target ulcers located on the plantar aspect of the foot must be offloaded for at... [+21]