CAMPR-II Trial: A multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a saline-hydrated allogeneic dual-layer amniotic membrane product or a synthetic, resorbable polymeric wound matrix to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs
Male or female 18 years of age and older
If a female is not currently pregnant or breastfeeding nor plans to become pregnant during the study and is either not of childbearing potential (defined as: postmenopausal [defined as amenorrhea for at least 1 year and serum follicle stimulating hormone (FSH) level >40 IU/L], or surgically sterile [bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or tubal ligation at least 6 months prior to IP administration]), or is practicing one or more of the following medically acceptable methods of birth control throughout the study.
Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives for a minimum of 1 full cycle (based on subject's usual menstrual cycle period) before Screening/Randomization Visit and must follow that product's package insert instructions including additional protection at times when hormonal contraceptive doses might be missed.
Total abstinence from sexual activities that can lead to pregnancy for at least 6 months prior to Screening/Randomization Visit. Abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle.
Inability to adhere to the study protocol or study visit schedule
Pregnancy
Child-bearing potential without appropriate contraception
Lactation
Parallel
Microlyte®
DeviceIP 2: Microlyte® is a sterile, single use absorbent polymeric wound matrix composed primarily of bioresorbable polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/in2. It absorbs wound fluid and forms a soft matrix that conforms to the wound surface and maintains a moist, wound-healing environment. The matrix contains silver only to prevent or minimize microbial growth within the matrix. Microlyte® Matrix is cleared by the U.S. Food and Drug Administration (FDA) under 510(k) \[K153756\] as a Class II device for the management of partial- and full-thickness wounds, including diabetic foot ulcers, venous stasis ulcers, pressure ulcers, surgical and traumatic wounds, and first- and second-degree burns and may be used over debrided and grafted partial-thickness wounds. It is fully synthetic and cleared as an antimicrobial barrier. The product is regulated under 21 CFR 878.4020 (dressing, wound,
IP 1: Membrane Wrap - Hydro
DeviceIP 1: Membrane Wrap - Hydro is a saline-hydrated allogeneic dual-layer amniotic membrane product that meets the criteria for regulation as a human cell, tissue, or cellular or tissue-based product (HCT/P) solely under section 361 of the Public Health Service (PHS) Act and 21 CFR part 1271. The amnion allograft is screened, processed, labeled, and distributed in a manner that prevents transmission of disease and is an allograft derived from donated human birth tissue. Membrane Wrap - Hydro amniotic membrane processing includes cleaning, rinsing, applying sterile mesh, folding to create a dual layer, drying then cutting, followed by hydration with sodium chloride solution 0.9%" and sterilization using irradiation. Membrane Wrap - Hydro™ is intended to serve "as a supportive barrier and provides protective coverage from the surrounding environment to acute and chronic wounds. Membrane Wrap-Hydro may be applied from the onset of the wound and for the duration of the wound.
Wound Reduction
To demonstrate the clinical effectiveness of IP1 and IP2 as an adjunct to standard of care in supporting wound reduction compared to standard of care alone in venous leg ulcers and diabetic foot ulcers across the continuum of care. Thus, the incidence of index ulcers obtaining complete wound reduction by 12 weeks will be collected.
Wound Percent Area Reduction
To demonstrate real world utilization and utility of two novel amniotic tissue grafts to support a variety of meaningful clinical outcomes in an at-risk patient population this study will collect wound percent area reduction at 4, 8, 12 weeks, change from baseline in quality of life, based on changes in index wound quality of life Wound-Q, and subject pain scores.
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Capsicure, LLC
Lead sponsor
BioLab Holdings
Collaborator
