CAMPR-II RWE TRIAL: 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 Hard to Heal DFUs and VLUs

NCT07701590 | Recruiting FDA Device

• 1 other identifier: CAMPR-II RWE
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Wound, Foot; Diabetic Foot Ulcer (DFU); Venus Leg Ulcer

Keywords

DFU; VLU; Venus Leg Ulcer; Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• 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.

  12 Weeks

Secondary Outcomes (1)

• Wound Percent Area Reduction

  Week 4, 8, and 12

Study Arms (3)

IP1: Membrane Wrap - Hydro

EXPERIMENTAL

The study will employ a platform umbrella design in which two studies will be run: one for diabetic foot ulcers and one for venous leg ulcers. Each study will have two intervention groups and one common SOC group. Subjects will be randomized to one of two interventions: IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap Subjects in the control group will be drawn from deidentified data sourced from the US Wound Registry. The US Wound Registry (USWR) is recognized by CMS as a Qualified Clinical Data Registry (QCDR). The matching of intervention to control groups will use coarsened exact matching (CSM) in which key variables are used to match: e.g., age, sex, baseline wound area, baseline wound age. The desired control subject pool should be three times larger than the prospective group (at least 147 in wound type.)

Device: IP 1: Membrane Wrap - Hydro

IP2: Microlyte®

EXPERIMENTAL

This study will employ a platform umbrella design in which two studies will be run: one for diabetic foot ulcers and one for venous leg ulcers. Each study will have two intervention groups and one common SOC group. Subjects will be randomized to one of two interventions: IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap Subjects in the control group will be drawn from deidentified data sourced from the US Wound Registry. The US Wound Registry (USWR) is recognized by CMS as a Qualified Clinical Data Registry (QCDR). The matching of intervention to control groups will use coarsened exact matching (CSM) in which key variables are used to match: e.g., age, sex, baseline wound area, baseline wound age. The desired control subject pool should be three times larger than the prospective group (at least 147 in wound type.)

Device: Microlyte®

Standard of Care

NO INTERVENTION

This study will employ a platform umbrella design in which two studies will be run: one for diabetic foot ulcers and one for venous leg ulcers. Each study will have two intervention groups and one common SOC group. Subjects will be randomized to one of two interventions: IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap Subjects in the control group will be drawn from deidentified data sourced from the US Wound Registry. The US Wound Registry (USWR) is recognized by CMS as a Qualified Clinical Data Registry (QCDR). The matching of intervention to control groups will use coarsened exact matching (CSM) in which key variables are used to match: e.g., age, sex, baseline wound area, baseline wound age. The desired control subject pool should be three times larger than the prospective group (at least 147 in wound type.)

Interventions

Microlyte® DEVICE

IP 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,

Also known as: IP 2: Microlyte®

IP2: Microlyte®

IP 1: Membrane Wrap - Hydro DEVICE

IP 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.

IP1: Membrane Wrap - Hydro

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Intrauterine device
• Vasectomized Partner (for at least 6 months)
• Double-barrier method (condoms and clerical cap with spermicidal jellies or cream or condoms and diaphragm with spermicidal jellies or cream or condoms and contraceptive foam).
• Negative pregnancy test for all subjects of childbearing potential
• Subjects having a non-healing venous leg ulcer or diabetic foot ulcer of \>4 weeks duration.
• No visible signs of healing objectively, less than 50% reduction in wound size in the last 4 weeks
• Subjects' wound size is minimum of 2 cm2 and maximum of 24cm2
• If the subject has more than one eligible wound the largest wound will be selected (the index wound)
• Subject is able and willing to follow the protocol requirements
• Subject has signed informed consent.

You may not qualify if:

• Inability to adhere to the study protocol or study visit schedule
• Pregnancy
• Child-bearing potential without appropriate contraception
• Lactation
• Treatment of the wound with engineered tissue or other scaffold materials within 30 days preceding the first treatment visit.
• Visible signs of improvement in the four weeks before randomisation (defined objectively as a 50% reduction in surface area in the four weeks before enrolment)
• The subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety
• Known contraindications to the use of either IP1 or IP2
• The index ulcer shows clinical signs and symptoms of wound infection needing treatment with local or systemic antimicrobials or antibiotics.

Sponsors & Collaborators

• Capsicure, LLC: lead
• BioLab Holdings: collaborator

Study Sites (7)

North Park Podiatry

San Diego, California, 92104, United States

RECRUITING

Solutions Medical Research

Coral Gables, Florida, 33134, United States

RECRUITING

NAR Medical and Research

Miami, Florida, 33135, United States

RECRUITING

Nova Medical Services - Research Division LLC

Miami, Florida, 33176, United States

RECRUITING

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

St. Louis Foot and Ankle, LLC

St Louis, Missouri, 63128, United States

RECRUITING

Hope Vascular and Podiatry

Houston, Texas, 77054, United States

RECRUITING

MeSH Terms

Conditions

Foot Injuries; Diabetic Foot

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Windy Cole, DPM

  Capsicure, LLC

  STUDY DIRECTOR

Central Study Contacts

Marissa Docter, RN, BSN, MD

CONTACT

512-571-2966; mdocter@capsicure.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: This study will employ a platform umbrella design in which two studies will be run: one for diabetic foot ulcers and one for venous leg ulcers. Each study will have two intervention groups and one common SOC group. Subjects will be randomized to one of two interventions: IP 1: Membrane Wrap - Hydro™ IP2: Microlyte® Matrix Subjects in the control group will be drawn from deidentified data sourced from the US Wound Registry. The US Wound Registry (USWR) is recognized by CMS as a Qualified Clinical Data Registry (QCDR). The matching of intervention to control groups will use coarsened exact matching (CSM) in which key variables are used to match: e.g., age, sex, baseline wound area, baseline wound age. The desired control subject pool should be three times larger than the prospective group (at least 165 in wound type.

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: June 22, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)