A multicenter prospective modified platform trial evaluating several cellular, acellular, and matrix like products and standard of care versus matched standard of care controls in the management of nonhealing pressure ulcers.
The potential subject must be at least 18 years of age or older.
The potential subject must agree to attend the weekly study visits required by the protocol.
The potential subject must be willing and able to participate in the informed consent process.
The potential subject must have a full-thickness pressure ulcer NPIAP stage 3 or stage 4 without exposed tendon or bone of greater than or equal to one month in duration located on the trunk (sacral, trochanteric, or ischial).
The potential subject is known to have a life expectancy of < 3 months.
The potential subject's target ulcer is not a pressure ulcer.
The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
The target ulcer exposes tendon or bone.
Parallel
Activate™ Matrix + SOC
Other interventionParticipants will receive weekly applications of Activate™ Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
AmnioDefend™ FT Matrix + SOC
Other interventionParticipants will receive weekly applications of AmnioDefend™ FT Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
Palisade™ DM Matrix + SOC
Other interventionParticipants will receive weekly applications of Palisade™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
Sentry™ SL Matrix + SOC
Other interventionParticipants will receive weekly applications of Sentry™ SL Matrix and Standard of Care until ulcer closure, or a maximum of 20 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 20 weeks, whichever occurs first.
Between Arm Difference for Complete Closure
Determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing pressure ulcers with multiple CAMPs plus SOC versus matched SOC controls (mSOC) over 20 weeks using a modified platform trial design.
Time to Closure
Determine the between-arm difference in the time to closure over 20 weeks for CAMP plus SOC versus mSOC.
Percentage Area Reduction
Determine the between-arm difference in the percent area reduction (PAR) at weekly intervals the CAMP plus SOC arms versus mSOC.
Pain Scale Reduction
Determine the between-arm difference in pain for patients that present with a Visual Analog Scale score of greater than 4. The scale is a rage of 0-10, 0 being no pain and 10 being worst pain imaginable.
Adverse Events
Evaluate the between-arm difference in the frequency and nature of adverse events in subjects receiving CAMP plus SOC versus mSOC.
Evaluate Quality of Life
Evaluate the between-arm difference in the quality of life for subjects receiving CAMP plus SOC compared to SOC only using the Forgotten Wound Score (FWS) at treatment visits 1, 4, 8, 12, 16, and 20.
Compliance with Off-loading
To determine compliance with off-loading and the effect on wound closure.
Ulcers to Close in Patients over 65
To determine the proportion of ulcers that close in patients 65 years or older for CAMP plus SOC versus mSOC.
Rate of Reoccurrence
Selected sites only: to demonstrate durability of closure (rate of recurrence) of subjects with a closed ulcer.
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Sequence LifeScience, Inc.
Lead sponsor
Serena Group
Collaborator
