Wound, FootCAMPR-IINCT07701590
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
A study testing Microlyte® and IP 1: Membrane Wrap - Hydro in people with Wound, Foot and Diabetic Foot Ulcer (DFU), run by Capsicure, LLC at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound, Foot, Diabetic Foot Ulcer (DFU), Venus Leg Ulcer
- What is being tested?
- Microlyte® and IP 1: Membrane Wrap - Hydro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 7 sitesUnited States
- Study dates
- 22 Jun 2026to 20 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 14Show fewer
- 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.
Who cannot join
- 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)
Show all 9Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Solutions Medical Research
Coral Gables, Florida, 33134
Liliana Lorenzo, 305-425-1238, lorenzo@solutionsmedicalresearch.com
Francisco Jose Oliva
- Recruiting
Hope Vascular and Podiatry
Houston, Texas, 77054
Jeena RoshanRaj, 346-541-6421, jroshanraj@hcic.io
Brian Lepow
- Recruiting
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202
Bryce Hockman, 317-278-2715, bbhockma@iu.edu
Mithun Sinha
- Recruiting
NAR Medical and Research
Miami, Florida, 33135
Lianne Batista, 786-803-8986, lbatista@narmedicalresearchgroup.com
Julio Arronte
- Recruiting
Nova Medical Services - Research Division LLC
Miami, Florida, 33176
Valmys Ortiz, 786-715-9183, Valmys.Ortiz@novamedicalcare.com
Sandor Romero
- Recruiting
North Park Podiatry
San Diego, California, 92104
Marbella Lara, 619-283-2097, marbella.npp1@gmail.com
Trent Brookshier
- Recruiting
St. Louis Foot and Ankle, LLC
St Louis, Missouri, 63128
Bonnie Weiss, 314-596-9670, blsweiss.practicemanager@gmail.com
Raymond Abdo
About this study
Official title: 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
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
Read the detailed description
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 hardto-heal DFUs and VLUs Hybrid prospective platform 2 arm, comparative, randomized multicenter study with a CSM matched retrospective control group Study type Interventional comparative study Study product • IP 1: Membrane Wrap - Hydro™ • IP2: Microlyte® Matrix CSM matched cohort Standard of care: Debridement, maintenance of proper moisture balance, reduction in bacterial burden, offloading and multilayer compression. Prospective patient population Patients with nonhealing venous leg ulcerations or diabetic foot ulcers of at least 4-weeks duration that have failed to show 50% PAR with SOC therapies Control population Patients receiving SOC therapies for hard-to-heal VLUs and/or DFUs Retrospective data to be extracted retrospectively from the US Wound Registry: Demographic information Geographic location Number of wounds Frequency and number of wound care appointments Treatments received Number of infections Amputations Hospitalization Time to complete wound closure PROMs (if available) Study purpose To gather prospective real-world evidence (RWE) in both diabetic foot ulcers and venous leg ulcers increasing the understanding of treatment performance in everyday clinical settings, capturing insights from a more diverse patient population than traditional clinical trials. This information is CAMPR-II Version 1.1 15 April 2026 7 vital for evaluating the effectiveness of innovative wound care strategies in practical, real-life scenarios Primary objective To demonstrate the clinical effectiveness of IP1 and IP2 as an adjunct to standard of care in supporting complete wound closure compared to standard of care alone in venous leg ulcers and diabetic foot ulcers across the continuum of care.
- Conditions
- Wound, Foot, Diabetic Foot Ulcer (DFU), Venus Leg Ulcer
- Being tested
- Microlyte®, IP 1: Membrane Wrap - Hydro
- Keywords
- DFU, VLU, Venus Leg Ulcer, Diabetic Foot Ulcer
- Medical subject headings
- Foot Injuries, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microlyte®Device
Also called IP 2: Microlyte®
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,
IP 1: Membrane Wrap - HydroDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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.) Receives: 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.) Receives: 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.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Weeks
Secondary outcomes (1)
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.
Measured: Week 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start22 Jun 2026
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound, FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capsicure, LLC
- Sponsor type
- Research network
- Collaborators
- BioLab Holdings
- Responsible party
- Sponsor
- Investigators
- Windy Cole, DPM, Study director, Capsicure, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701590
- Sponsor's protocol ID
- CAMPR-II RWE
- Acronym
- CAMPR-II
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Neither the complete nor any part of the results of the study carried out under this protocol, nor any of the information provided by the sponsor for the purposes of performing the study, will be published or passed on to any third party without the consent of the study sponsor. Any investigator involved with this study is obligated to provide the sponsor with complete test results and all data derived from the study.