This is a multicenter, prospective, randomized controlled modified multi-platform (matriarch) trial evaluating several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus standard of care alone in the management of nonhealing diabetic foot and venous leg ulcers.
The purpose of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers and venous leg ulcers with multiple CAMPs plus SOC versus SOC alone over 12 weeks using a modified dual platform (Matriarch) trial design. \*The initial plan is to evaluate five CAMPs per wound type; however, the modified platform design permits the inclusion of additional CAMPs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
324
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Participants will receive weekly applications of AmnioCore and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Participants will receive weekly applications of Amnio Quad-Core and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Cutting Edge Research
Circleville, Ohio, United States
RECRUITINGDetermine the between-arm difference
To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers and venous leg ulcers with multiple CAMPs plus SOC versus SOC alone over 12 weeks using a modified dual platform (Matriarch) trial design.
Time frame: 1-12 Weeks
Time to closure
To determine the between-arm difference in the time to closure over 12 weeks for CAMP plus SOC versus SOC alone.
Time frame: 1-12 Weeks
Percent Area Reduction
To determine the between-arm difference in the percent area reduction (PAR) at weekly intervals the CAMP plus SOC arms versus SOC alone.
Time frame: 1-12 weeks
Change in pain in target ulcer
To determine the between-arm difference in pain for patients that present with a VAS score of greater than 4.
Time frame: 1-12 Weeks
Adverse Events
To evaluate the between-arm difference in the frequency and nature of adverse events in subjects receiving CAMP plus SOC versus SOC alone.
Time frame: 1-14 weeks
Determine improvement in Quality of Life - FWS and determine improvement in Quality of Life - wQOL
To evaluate the between-arm difference in the quality of life for subjects receiving CAMP plus SOC compared to SOC alone using the Forgotten Wound Score (FWS) and standard Wound Quality of Life (wQOL) questionnaires at treatment visits 1, 4, 8, and 12.
Time frame: 1-12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and compression) until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Participants will receive weekly applications of Amnio Tri-Core and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Participants will receive weekly applications of AmnioCore Pro and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Participants will receive weekly applications of Amniocore Pro + and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.