Diabetic Foot Ulcer (DFU)CAMP RWENCT07046767
CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations
A study testing IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap and IP2: BioLab Tri-Membrane Wrap in people with Diabetic Foot Ulcer (DFU) and Venous Leg Ulcer, run by Capsicure, LLC at 7 sites in United States.
Trial summary
CAMP RWE Trial: A Multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a tri-layer amnion graft or a single layer amnion graft to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcer, Wound; Foot
- What is being tested?
- IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap and IP2: BioLab Tri-Membrane Wrap
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Oct 2025to 20 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 2. Subjects having a non-healing venous leg ulcer or diabetic foot ulcer of >4 weeks duration and 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 25cm2
- 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)
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- The subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety
- Known contraindications to the use of amniotic tissue grafts
- 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, liliana@solutionsmedicalresearch.com
Francisco Jose Oliva, DPM
- Recruiting
Hope Vascular and Podiatry
Houston, Texas, 77054
Mariana Burnier, 346-541-6421, mburnier@hcic.io
Brian Lepow, DPM
- Recruiting
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202
Bryce Hockman, 317-278-2715, bbhockma@iu.edu
Mithun Sinha, PhD
- Recruiting
Nova Medical Services - Research Division LLC
Miami, Florida, 33176
Valmys Ortiz, 786-715-9183, Valmys.Ortiz@novamedicalcare.com
Sandor Romero, MD
- Recruiting
FOMAT Medical Research
Oxnard, California, 93030
Luis Parra, 805-483-1185, lparra@fomatmedical.com
David Blitzer, MD
- Recruiting
St. Louis Foot and Ankle, LLC
St Louis, Missouri, 63128
Bonnie Scaggs, 314-596-9670, stlabdopodiatry@gmail.com
Raymond Abdo, DPM
- Recruiting
Jevlos Health, Inc
Syosset, New York, 11791
Christopher Infantino, 516-816-8160, Christopher.Infantino@jevloshealth.org
Mamta Parikh, MD
About this study
Official title: A Multicenter Hybrid Platform Trial Comparing the Effects of a Prospective Cohort Treated With a Tri- Layer Amnion Graft or a Single Layer Amnion Graft to a Coarsened Exact Matched Retrospective Control Cohort of Patients With Hard-to-heal DFUs and VLUs
CAMP RWE Trial: A Multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a tri-layer amnion graft or a single layer amnion graft 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 tri layer amnion graft or a single layer amnion graft to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs
Hybrid prospective platform 2 arm, comparative, randomized multicenter study with a CSM matched retrospective control group Interventional comparative study
- IP 1: BioLab Membrane Wrap Lite
- IP2: BioLab Tri-Membrane Wrap
Standard of care: Debridement, maintenance of proper moisture balance, reduction in bacterial burden, offloading and multilayer compression.
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 Patients receiving SOC therapies for hard-to-heal VLUs and/or DFUs
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 vital for evaluating the effectiveness of innovative wound care strategies in practical, real-life scenarios
To demonstrate the clinical effectiveness of IP1 and IP2 as an adjunct to standard of care in supporting wound healing compared to standard of care alone in venous leg ulcers and diabetic foot ulcers across the continuum of care.
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcer, Wound; Foot
- Being tested
- IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap, IP2: BioLab Tri-Membrane Wrap
- Keywords
- DCF, VLU, Diabetic Foot Ulcer, Venus Leg Ulcer
- Medical subject headings
- Diabetic Foot, Varicose Ulcer, Foot Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane WrapOther
BioLab Membrane Wrap LiteTM is a human tissue allograft derived from the amniotic membrane that provides structural tissue for use as a wound and protectant covering. Membrane Wrap LiteTM is a single-layer human tissue allograft, containing solely the amnion layer of Amniotic Membrane [Human Cellular and Tissue Based Product (HCT/P)] for transplantation regulated by the US Food and Drug Administration under 21 CFR Part 1271.
IP2: BioLab Tri-Membrane WrapOther
BioLab Tri-Membrane WrapTM is a human tissue allograft derived from the amniotic membrane that provides structural tissue for use as a wound and protectant covering. Tri-Membrane WrapTM is a triple-layered human tissue allograft, containing amnion-chorion-amnion layers [Human Cellular and Tissue Based Product (HCT/P)] for transplantation regulated by the US Food and Drug Administration under 21 CFR Part 1271.
| Study group | Role | What they receive |
|---|---|---|
| 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 165 in wound type.) |
| IP1: BioLab Membrane Wrap Lite | 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 165 in wound type.) Receives: Other: IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap |
| IP2: BioLab Tri-Membrane Wrap | 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 165 in wound type.) Receives: Other: IP2: BioLab Tri-Membrane Wrap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Closure
To demonstrate the clinical effectiveness of IP1 and IP2 as an adjunct to standard of care in supporting wound healing 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 closure 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: Weeks 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 posted1 Jul 2025
- Study start1 Oct 2025
- Primary completion20 Jul 2026 (estimated)
- Study completion20 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcer (DFU)Studies 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: 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 165 in wound type).
- Masking
- None (open label)
- Enrolment
- 165 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
- NCT07046767
- Sponsor's protocol ID
- CAMP RWE
- Acronym
- CAMP RWE
- Status last verified
- Oct 2025
- First submitted
- 23 Jun 2025
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Hybrid Platform Trial Comparing the Effects of a Prospective Cohort Treated With a Tri- Layer Amnion Graft or a Single Layer Amnion Graft to a Coarsened Exact Matched Retrospective Control Cohort of Patients With Hard-to-heal DFUs and VLUs
- ClinicalTrials.gov ID
- NCT07046767
- Acronym / sponsor ID
- CAMP RWE / CAMP RWE
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcer, Wound; Foot
- Keywords
- DCF, VLU, Diabetic Foot Ulcer, Venus Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Capsicure, LLCResearch network
- Collaborators
- BioLab Holdings
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 20 Jul 2026 (estimated)
- Study completion
- 20 Jul 2026 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CAMP RWE Trial: A Multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a tri-layer amnion graft or a single layer amnion graft to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs
Detailed description
A multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a tri layer amnion graft or a single layer amnion graft to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs
Hybrid prospective platform 2 arm, comparative, randomized multicenter study with a CSM matched retrospective control group Interventional comparative study
- IP 1: BioLab Membrane Wrap Lite
- IP2: BioLab Tri-Membrane Wrap
Standard of care: Debridement, maintenance of proper moisture balance, reduction in bacterial burden, offloading and multilayer compression.
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 Patients receiving SOC therapies for hard-to-heal VLUs and/or DFUs
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 vital for evaluating the effectiveness of innovative wound care strategies in practical, real-life scenarios
To demonstrate the clinical effectiveness of IP1 and IP2 as an adjunct to standard of care in supporting wound healing compared to standard of care alone in venous leg ulcers and diabetic foot ulcers across the continuum of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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: 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 165 in wound type).
| Arm | Type | Receives |
|---|---|---|
| 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 165 in wound type.) |
| IP1: BioLab Membrane Wrap Lite | Experimental | Other: IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane WrapThis 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 165 in wound type.) |
| IP2: BioLab Tri-Membrane Wrap | Experimental | Other: IP2: BioLab Tri-Membrane WrapThis 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 165 in wound type.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female 18 years of age and older
- 2. Subjects having a non-healing venous leg ulcer or diabetic foot ulcer of >4 weeks duration and 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 25cm2
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane WrapBioLab Membrane Wrap LiteTM is a human tissue allograft derived from the amniotic membrane that provides structural tissue for use as a wound and protectant covering. Membrane Wrap LiteTM is a single-layer human tissue allograft, containing solely the amnion layer of Amniotic Membrane [Human Cellular and Tissue Based Product (HCT/P)] for transplantation regulated by the US Food and Drug Administration under 21 CFR Part 1271. | Other | IP1: BioLab Membrane Wrap Lite |
| IP2: BioLab Tri-Membrane WrapBioLab Tri-Membrane WrapTM is a human tissue allograft derived from the amniotic membrane that provides structural tissue for use as a wound and protectant covering. Tri-Membrane WrapTM is a triple-layered human tissue allograft, containing amnion-chorion-amnion layers [Human Cellular and Tissue Based Product (HCT/P)] for transplantation regulated by the US Food and Drug Administration under 21 CFR Part 1271. | Other | IP2: BioLab Tri-Membrane Wrap |
Primary outcome
Wound Closure
Time frame: 12 Weeks
To demonstrate the clinical effectiveness of IP1 and IP2 as an adjunct to standard of care in supporting wound healing 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 closure by 12 weeks will be collected.
1 secondary outcome
Wound percent area reduction
Time frame: Weeks 4, 8, and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Windy Cole, DPM study director
Capsicure, LLC
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap and IP2: BioLab Tri-Membrane Wrap in people with Diabetic Foot Ulcer (DFU) and Venous Leg Ulcer, run by Capsicure, LLC at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marissa Docter, RN, BSN, MD (512-571-2966, mdocter@capsicure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Closure (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.