The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal diabetic foot ulcers over 12 weeks using a modified platform trial design.
The CAMPSTIM trial is a prospective, multicenter, randomized, controlled clinical trial to evaluate four separate CAMPs (Cellular, Acellular, Matrix-like Products), Revita®, Relese®, Cogenex®, and Enverse®. The study utilizes a unique modified platform trial to evaluate multiple cellular and/or tissue-based products (CTPs) in a single trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
272
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 Revita and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Relese and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
SerenaGroup Omaha Research Center
Omaha, Nebraska, United States
RECRUITINGWound Care of Tulsa
Tulsa, Oklahoma, United States
RECRUITINGSerenaGroup Research South
Jefferson Hills, Pennsylvania, United States
The percentage of target ulcers achieving complete wound closure
Determine the percent of target ulcers achieving complete wound closure at 12 weeks. In addition, a qualified third-party clinician will independently confirm wound closure.
Time frame: 1-12 weeks
Time to closure for the target ulcer
Time to closure will be determined for each treatment group and compared to SOC.
Time frame: 1-12 weeks
Percent area reduction
Percent Area Reduction (PAR) will be calculated from Treatment Visit (TV)-1 to Treatment Visit (TV)-13.
Time frame: 1-12 weeks
Adverse events
Incidence of adverse events will be evaluated weekly from TV-1 to the healing confirmation visit (HCV).
Time frame: 1-14 weeks
Change in pain in target ulcer
Change in target ulcer pain assessed using the Pain, Enjoyment of Life and General Activity (PEG) scale (0 to 10 where higher score indicates more severe pain and pain-related interference with life and activities) at TV-1, TV-4, TV-7, TV-10, and TV-13.
Time frame: 1-14 weeks
Determine improvement in Quality of Life - wQOL
Quality of Life assessed using the Wound Quality of Life (wQOL) checklist at TV-1, TV- 4, TV-7, TV- 10, and TV-13.
Time frame: 12 weeks
Determine improvement in Quality of Life - FWS
Quality of Life assessed using the Forgotten Wound Score (FWS) at TV-1, TV- 4, TV-7, TV- 10, and TV-13.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participants will receive weekly applications of Cogenex and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Enverse and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, United States
NOT_YET_RECRUITINGSerenaGroup Monroeville
Monroeville, Pennsylvania, United States
RECRUITINGTime frame: 12 weeks