The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) over 12 weeks using a modified platform trial design.
The C5CAMP trial is a multicenter, prospective, randomized controlled clinical trial to evaluate subjects that meet medical necessity criteria for cellular, acellular, and matrix-like products (CAMPs). The study utilizes a prospective modified platform design to evaluate two separate CAMPs, AM/Single and AM/Double in a single trial. The initial plan is to evaluate two CAMPs; however, the modified platform design permits the inclusion of additional CAMPs. This study will evaluate the clinical utility of multiple CAMPs in the closure of diabetic foot ulcers and venous leg ulcers in subjects in comparison to Standard of Care treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
177
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 12 weeks, whichever occurs first.
Participants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
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 12 weeks, whichever occurs first.
Participants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Poirot Podiatry
Metairie, Louisiana, United States
RECRUITINGDetermine the percentage of subjects achieving complete closure of target ulcer over 12 weeks.
The proportion of subjects achieving complete wound closure of target ulcer.
Time frame: 1-12 weeks
Time to closure for target ulcer.
Length of time in days to closure will be determined for each treatment group and compared to SOC alone.
Time frame: 1-12 weeks
Percent Area Reduction (PAR)
Percent Area Reduction (PAR) will be calculated from Treatment Visit (TV)-1 to TV-13 measured weekly with digital photographic planimetry, using imaging device, and physical examination.
Time frame: 1-12 weeks
Adverse Events
Determine number of adverse events
Time frame: 1-12 weeks
Change in pain in target ulcer
Change in pain in target ulcer assessed using the Pain, Enjoyment of Life and General Activity (PEG) scale
Time frame: 1-12 weeks
Determine improvement in quality of life
Quality of life assessed using the Wound Quality of Life (wQOL) at TV-1, TV-4, TV-8, TV-12 / Final Visit
Time frame: 1-12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.