The study is a multicenter, prospective, controlled modified multi-platform trial assessing the efficacy of human placental membrane products and standard of care in the management of nonhealing diabetic foot ulcers and venous leg ulcers.
This study follows a rescue design: patients in the SOC arm who fail to heal during the BIOCAMP Prospective Modified Dual Platform Multicenter Randomized Controlled Clinical Trial will enter the Rescue trial and receive one of the study products. Patients enrolled in this trial must still meet medical necessity criteria for cellular, acellular, matrix-like, products (CAMPs) recently published by the Medicare Administrative Contractor's (MAC) in their local coverage determinations (LCD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Participants will receive weekly applications of Tri-Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Membrane Wrap-Lite™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Membrane Wrap-Hydro™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Tri-Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Membrane Wrap-Lite™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Membrane Wrap-Hydro™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Center for Foot and Ankle Disorders
Philidelphia, Pennsylvania, United States
RECRUITINGPercentage of Wound Closure
The percentage of target ulcers achieving complete wound closure in 12 weeks.
Time frame: 1-12 Weeks
Time to Closure
Time to closure for the target ulcer.
Time frame: 1-12 weeks
Percentage Area Reduction
Percentage wound area reduction from TV-1 to TV-13 measured weekly with digital photographic planimetry, using imaging device, and physical examination.
Time frame: 1-12 weeks
Adverse Events
The number of product- or procedure- related adverse events.
Time frame: 1-12 Weeks
Determine improvement in Quality of Life
To determine the between-arm difference in the quality of life for subjects receiving HPM plus SOC compared to SOC alone using the Forgotten Wound Score (FWS) questionnaire. Forgotten wound scores situations on a scale of "never" to "mostly."
Time frame: 1-12 weeks
Determine improvement in Quality of Life
To determine the between-arm difference in the quality of life for subjects receiving HPM plus SOC compared to SOC alone using the Wound Quality of Life (wQOL) questionnaire. Scores on a scare from "Not at all" to "Very much."
Time frame: 1-12 weeks
Pain in patients who present with VAS greater than 4
To determine the between-arm difference in pain for patients that present with a Visual Analog Sale (VAS) score of greater than 4. The VAS has a scale of 0-10. 0 Meaning no pain and 10 being the worst pain
Time frame: 1-12 Weeks
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