Dehydrated Human Amnion Membrane and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAxolotl Biologix
About this trial
The purpose of this study is to evaluate the efficacy of dehydrated human amnion membrane (dhAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).
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 1.0 cm2 and a maximum surface area of 5.0 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 offloading 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
- Standard of Care
- Axolotl DualGraft + SOC
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Axolotl Biologix
Lead sponsor
SerenaGroup, Inc.
Collaborator
Source ClinicalTrials.gov