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
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male or female 18 years of age and older 2. 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. 1. 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. 2. 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. 3. Intrauterine device 4. Vasectomized Partner (for at least 6 months) 5. 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). 3. Negative pregnancy test for all subjects of childbearing potential 4. Subjects having a non-healing venous leg ulcer or diabetic foot ulcer of >4 weeks duration. 5. No visible signs of healing objectively, less than 50% reduction in wound size in the last 4 weeks 6. Subjects' wound size is minimum of 2 cm2 and maximum of 24cm2 7. If the subject has more than one eligible wound the largest wound will be selected (the index wound) 8. Subject is able and willing to follow the protocol requirements 9. Subject has signed informed consent.
Exclusion Criteria
- Inability to adhere to the study protocol or study visit schedule 2. Pregnancy 3. Child-bearing potential without appropriate contraception 4. Lactation 5. Treatment of the wound with engineered tissue or other scaffold materials within 30 days preceding the first treatment visit. 6. 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) 7. The subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety 8. Known contraindications to the use of either IP1 or IP2 9. The index ulcer shows clinical signs and symptoms of wound infection needing treatment with local or systemic antimicrobials or antibiotics.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention 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.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental IP1: Membrane Wrap - Hydro |
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.) |
|
|
Experimental IP2: Microlyte® |
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.) |
|
|
No Intervention Standard of Care |
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.) |
|
Recruiting Locations
North Park Podiatry
San Diego, California 92104
San Diego, California 92104
Solutions Medical Research
Coral Gables, Florida 33134
Coral Gables, Florida 33134
NAR Medical and Research
Miami, Florida 33135
Miami, Florida 33135
Nova Medical Services - Research Division LLC
Miami, Florida 33176
Miami, Florida 33176
Indiana University Health Methodist Hospital
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
St. Louis Foot and Ankle, LLC
St Louis, Missouri 63128
St Louis, Missouri 63128
Hope Vascular and Podiatry
Houston, Texas 77054
Houston, Texas 77054
More Details
- Status
- Recruiting
- Sponsor
- Capsicure, LLC
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.