RecruitingNot ApplicableNCT06564831

Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care

A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers

Sponsor

Applied Biologics, LLC

Enrollment

124 participants

Start Date

Sep 20, 2024

Study Type

INTERVENTIONAL

Conditions

Diabetic Foot Ulcer Diabetic Foot Foot Ulcer Ulcer Foot DFU

Summary

A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care versus Standard of Care alone in the management of Nonhealing Diabetic Foot Ulcers

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying SLAM + SOC and SOC for people with dfu, diabetic foot, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERSLAM + SOC

Weekly Treatment visits for 12 weeks begin at day 0. SLAM applications with SOC until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHERSOC

Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.