The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.
The potential subject must be at least 18 years of age or older.
The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.
At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 15.0 cm2 measured post debridement with the imaging device length times width.
The potential subject must have a target ulcer that has been present for a minimum of 4 weeks of standard of care, prior to the initial screening visit.
The potential subject must have a target ulcer located on the 50% below the malleolus and not on the dorsal toes.
The ulcer must be offloaded for at least 14 days prior to enrollment.
The potential subject must consent to using the prescribed offloading method for the duration of the study.
The potential subject must agree to attend the weekly study visits required by the protocol.
Parallel
Activate™ Matrix
Other interventionParticipants will receive weekly applications of Activate™ Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
AmnioDefend™ FT Matrix
Other interventionParticipants will receive weekly applications of AmnioDefend™ FT Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Palisade™ DM Matrix
Other interventionParticipants will receive weekly applications of Palisade™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Enclose™ TL Matrix
Other interventionParticipants will receive weekly applications of Enclose™ TL Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Sentry™ SL Matrix
Other interventionParticipants will receive weekly applications of Sentry™ SL Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Shelter™ DM Matrix + SOC
Other interventionParticipants will receive weekly applications of Shelter™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
6
Treatment groupsSee each treatment group below.
Between-arm difference in subjects achieving complete closure
To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.
Time to closure
To determine the between-arm difference in the time to closure over 12 weeks for CAMP plus SOC versus matched control subjects.
Percentage area reduction rate
To determine the between-arm difference in percent area reduction (PAR) at weekly intervals for CAMP plus SOC versus matched control subjects.
Adverse Events
To determine the between-arm difference in the frequency and nature of adverse events in subjects receiving CAMP plus SOC versus matched control subjects.
Determine quality of life
To determine the between-arm difference in quality of life for subjects receiving CAMP plus SOC versus matched control subjects using the Forgotten Wound Score (FWS). The FWS is scored on a scale of 0-4. 0 being never and 4 being mostly.
Click on the lead sponsor to view all of their trials.
Sequence LifeScience, Inc.
Lead sponsor
Serena Group
Collaborator
