Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorApplied Biologics, LLC
About this trial
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 criteria
Qualifiers
Subjects must be at least 18 years of age or older,
Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
At randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement.
The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
Disqualifiers
The subject must consent to using the prescribed off-loading method for the duration of the study.
The subject must agree to attend the weekly study visits required by the protocol.
The subject must be willing and able to participate in the informed consent process.
A subject known to have a life expectancy of < 6 months is excluded.
Trial design
Treatments tested in this trial
- SLAM + SOC
- SOC
Treatment groups
124 Participants
are divided into 2 treatment groupsSponsors and collaborators
Applied Biologics, LLC
Lead sponsor
SerenaGroup, Inc.
Collaborator
Source ClinicalTrials.gov