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
Key facts
- Who runs it
- Capsicure, LLC
- Where
- Coral Gables, Houston, Indianapolis, Miami, San Diego, and St Louis, United StatesSee the 7 sites
- Trial code
- Status
- Recruiting
- People taking part
- 147 people, planned
- Started
- 22 Jun 2026
- Expected to end
- 20 Dec 2026
- Type of study
- Interventional, 3 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Microlyte®
- IP 1: Membrane Wrap - Hydro
- Record updated
- 14 July 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- The index ulcer shows clinical signs and symptoms of wound infection needing treatment with local or systemic antimicrobials or antibiotics
- 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
- Known contraindications to the use of either IP1 or IP2
Where in United States
- Solutions Medical ResearchCoral Gables, United StatesContact: Liliana LorenzoTaking people
- HOPE Vascular and PodiatryHouston, United StatesContact: Jeena RoshanRajTaking people
- Indiana University Health Methodist HospitalIndianapolis, United StatesContact: Bryce HockmanTaking people
- NAR Medical and ResearchMiami, United StatesContact: Lianne BatistaTaking people
- Nova Medical Services - Research Division LLCMiami, United StatesContact: Valmys OrtizTaking people
- North Park PodiatrySan Diego, United StatesContact: Marbella LaraTaking people
- St. Louis Foot and Ankle, LLCSt Louis, United StatesContact: Bonnie WeissTaking people
About the trial
What the trial wants to find out
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
The 3 groups in the trial
- IP1: Membrane Wrap - HydroTreatment being tested
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.)
Treatment: IP 1: Membrane Wrap - Hydro
- IP2: Microlyte®Treatment being tested
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.)
Treatment: Microlyte®
- Standard of CareNo study treatment, for comparison
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.)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 14 July 2026