Amnion Grafts for Foot Ulcers
(CAMP RWE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine how two types of amnion grafts (a type of tissue wrap) aid in healing stubborn foot or leg ulcers. Participants will receive either a single-layer wrap (BioLab Membrane Wrap Lite) or a tri-layer wrap (BioLab Tri-Membrane Wrap) to assess which is more effective. The trial targets individuals with diabetic foot ulcers or venous leg ulcers that have shown minimal healing over four weeks and measure between 2 cm² and 25 cm². Participants should have had these ulcers for over four weeks with little visible healing. As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance healing options for chronic ulcers.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if your wound is infected and requires antibiotics, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that amnion grafts, such as the BioLab Membrane Wrap Lite and the BioLab Tri-Membrane Wrap, are undergoing safety testing for treating foot and leg ulcers. These treatments use layers of human amniotic membrane, a natural tissue that protects the baby in the womb, to aid in wound healing.
Studies have found that these amnion-based products are generally well-tolerated for diabetic foot ulcers and venous leg ulcers. The research available has reported no major safety concerns. Some minor side effects, like mild irritation or redness at the application site, might occur but are uncommon.
Both the Membrane Wrap Lite and the Tri-Membrane Wrap are currently in trials to gather more information. These studies aim to confirm their safety and effectiveness. So far, evidence suggests they are safe for their intended use. However, as with any medical treatment, potential trial participants should discuss possible risks with their healthcare provider.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these amnion graft treatments for foot ulcers because they offer a novel approach by using biological materials to promote healing. Unlike traditional treatments that often rely on topical applications or surgical interventions, the BioLab Membrane Wrap Lite and BioLab Tri-Membrane Wrap employ advanced amniotic membranes, which are known for their regenerative properties. These membranes can enhance wound healing by providing essential growth factors and reducing inflammation. This unique mechanism could potentially accelerate recovery times and improve outcomes for patients with diabetic foot ulcers or venous leg ulcers compared to current standard care options.
What evidence suggests that this trial's treatments could be effective for foot ulcers?
Research has shown that amnion grafts, like the BioLab Membrane Wrap Lite and BioLab Tri-Membrane Wrap, studied in this trial, can aid in healing chronic wounds such as diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). Made from human placental membrane, these products have shown promise when used with standard care, improving healing outcomes. Studies indicate that these grafts may speed up healing and reduce wound size compared to standard treatment alone. Designed to repair tissue and reduce inflammation, these amnion-based products play a crucial role in healing stubborn wounds. Early results suggest these grafts could be a valuable option for individuals with hard-to-heal ulcers.14567
Who Is on the Research Team?
Windy Cole, DPM
Principal Investigator
Capsicure, LLC
Are You a Good Fit for This Trial?
This trial is for adults over 18 with non-healing venous leg ulcers or diabetic foot ulcers present for more than 4 weeks, showing less than half size reduction in the past month. The wound must be between 2 and 25 cm². Participants need to follow protocol and give informed consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the BioLab Membrane Wrap Lite or the BioLab Tri-Membrane Wrap as an adjunct to standard of care for wound healing
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BioLab Membrane Wrap Lite
- BioLab Tri-Membrane Wrap
Trial Overview
The CAMP RWE Trial is testing two types of amnion graft wraps: a single-layer (BioLab Membrane Wrap Lite) and a tri-layer (BioLab Tri-Membrane Wrap), against matched historical controls, to see which better heals chronic foot and leg ulcers.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
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.)
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.)
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.)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Capsicure, LLC
Lead Sponsor
BioLab Holdings
Industry Sponsor
Citations
Trial Assessing the Efficacy of Human Placental Membrane ...
The purpose of this study is to evaluate the efficacy of human placental membrane products and standard of care versus standard of care alone in the management ...
Diabetic Foot and Venous Leg Ulcers Treated With ...
The company stated that BIOCAMP is its most comprehensive clinical trial to date and is designed to capture real-world clinical outcomes and ...
3.
prnewswire.com
prnewswire.com/news-releases/biolab-holdings-inc-announces-multiple-clinical-trials-to-advance-chronic-wound-care-302598682.htmlBioLab Holdings Inc. Announces Multiple Clinical Trials to ...
BioLab is also conducting a real-world data collection trial evaluating human amniotic membrane(s) on diabetic foot ulcers, venous leg ulcers, ...
Trial Assessing the Efficacy of Human Placental Membrane ...
The purpose of this study is to evaluate the efficacy of human placental membrane products and standard of care versus standard of care alone in ...
5.
ctv.veeva.com
ctv.veeva.com/study/trial-assessing-the-efficacy-of-human-placental-membrane-products-and-standard-of-care-versus-standaTrial Assessing the Efficacy of Human Placental Membrane ...
The purpose of this study is to evaluate the efficacy of human placental membrane products and standard of care versus standard of care alone in ...
BioLab Holdings Inc. Announces Multiple Clinical Trials to ...
BioLab is also conducting a real-world data collection trial evaluating human amniotic membrane(s) on diabetic foot ulcers, venous leg ulcers, ...
7.
uhcprovider.com
uhcprovider.com/content/dam/provider/docs/public/policies/medicaid-comm-plan/skin-soft-tissue-substitutes-cs.pdfSkin and Soft Tissue Substitutes – Community Plan ...
Membrane Wrap-Lite (BioLab Sciences, Inc.) is a human amnion ... diabetic foot ulcers and venous leg ulcers. Foot Ankle Spec. 2011 ...
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