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Largest Prospective Trial of Placental Tissue Allograft for Diabetic Foot Ulcers

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  • Fifirst diabetic foot ulcer (DFU) study in the United States using a modified platform trial design to demonstrate the effectiveness of multiple products in a single clinical trial.
  • First to Integrate Continuous Glucose Monitoring in a DFU Study of Cellular, Acellular, and Matrix Products (CAMP)

ROSWELL, Ga., June 4, 2024 /PRNewswire/ — StimLabs, a leading regenerative medicine company, announced Institutional Review Board (IRB) approval to begin the CAMPSTIM clinical trial, a multicenter randomized controlled trial aimed at demonstrating real-world benefits of tissue products based on placenta from StimLabs. in the treatment of patients with difficult-to-heal diabetic foot ulcers (DFUs).

“This trial is the first primary trial design in the United States in non-healing DFU studies to demonstrate the effectiveness of multiple products in a single trial, the first DFU trial to use continuous glucose monitoring and the largest prospective DFU trial involving placental-based CAMPs,” said. Thomas E. Serena, MD, FACS, FACHM, MAPWCA, founder and medical director of SerenaGroup® and principal investigator of the trial. He added: “This platform, along with similar master trial designs, represent the future of clinical research in the industry. SerenaGroup is excited to manage this innovative study with the StimLabs team, who have consistently demonstrated innovation in wound care.

In United StatesDFUs occur in 1.6M diabetic patients every year1. These ulcers recur frequently and often lead to serious complications such as skin and soft tissue infections, osteomyelitis, amputation, sepsis, and death. The longer a DFU remains open, the greater the risk of complications.2 Despite advances in treatment, less than 50% of UUPs are cured at 12 weeks.3 Additionally, more than 90% of DFUs with less than 50% area reduction after 4 weeks of standard care (SOC) do not heal.4 These alarming cure rates highlight the need for effective CAMPs, also known as skin substitutes, in patients suffering from DFU.

“Together with SerenaGroup, we have carefully designed a comprehensive, standardized assay using advanced technologies to ensure the highest quality results,” said Jean-Daniel, founder and CEO of StimLabs. The CAMPSTIM trial includes a protocol that will ensure consistency across sites through the inclusion of digital devices to provide wound and bacterial load measurements and the incorporation of continuous blood glucose monitoring for each patient. Additionally, it standardizes the use of Mölnlycke Health Care’s market-leading dressing, Mepilex® Border Flex, as well as the additional use of Mölnlycke’s gelling fiber dressing, Exufiber® in heavily exuding wounds.

CAMPSTIM will evaluate at least four distinct StimLabs CAMPs (Enverse®, Revita®, Relese® and Cogenex®) with SOC versus SOC alone, in the treatment of patients with non-healing DFU. The study uses a unique modified platform trial design, adapted from clinical trials developed during the pandemic to test multiple interventions within a single trial. This is the first such design used for DFUs in the United States. As the largest planned prospective clinical study of placental tissue allografts to date, CAMPSTIM will enroll approximately 272 patients at multiple sites in the United States.

The primary endpoint of the study will be the percentage of target ulcers achieving complete wound closure in 12 weeks. Secondary endpoints include time to closure, percentage reduction in wound area, number of adverse events, and changes in pain and quality of life.

“This highly vulnerable patient population will greatly benefit from the best technologies to support their wound care. Through this new trial, we look forward to demonstrating the power of our unique portfolio of placental tissue allografts,” said Jean-Daniel.

Unlike many placental allografts on the market, the StimLabs product configurations used in this study retain all three layers of the native placental membrane: the amnion, chorion, and middle layer. This is made possible thanks to patented Clearify® technology, which preserves the integrity of the membrane ensuring that it remains intact during processing. By never delaminating tissue, StimLabs grafts result in complete, full-thickness products that retain essential structural proteins and growth factors that play a crucial role in wound resolution.

About StimLabs
StimLabs LLC’s mission is to advance regenerative medicine, currently focusing on wound care and surgical applications. Comprised of industry leaders, StimLabs is dedicated to providing patients with the best possible care while recognizing the urgency of providing solutions in areas of unmet need. StimLabs has a comprehensive product portfolio addressing various clinical applications and has established a strong catalog of intellectual property. Committed to providing superior quality products, StimLabs is a trusted partner for both doctors and patients. https://stimlabs.com.

About Mölnlycke
Mölnlycke Health Care is a world-leading MedTech company specializing in innovative solutions for wound care and surgical procedures. Mölnlycke products and solutions are used daily by hospitals, healthcare providers and patients in more than 100 countries around the world. Founded in 1849, Mölnlycke is owned by Investor AB and is headquartered in Sweden. www.molnlycke.com

Media Contact:
Stimulation laboratories
(email protected)
(470) 616-0958

1. Voelker R. What are diabetic foot ulcers? JAMA. 2023;330(23):2314. doi:10.1001/jama.2023.17291

2. National Diabetes Foot Care Audit: https://digital.nhs.uk/data-and-information/clinical-audits-and-registries/national-diabetes-foot-care-audit. Accessed February 3, 2024.

3. Fife CE, Eckert KA, Carter MJ. Publicly reported wound healing rates: fantasy and reality. Advanced wound care (Nouvelle Rochelle). 2018 1st of March;7(3):77-94. doi: 10.1089/wound.2017.0743. PMID: 29644145; PMCID: PMC5833884.

4. A post-hoc analysis of reduction in diabetic foot ulcer size at 4 weeks as a predictor of healing at 12 weeks. (2010). Wound Management and Prevention, 56(3). https://www.hmpgloballearningnetwork.com/site/wmp/content/a-post-hoc-analysis-reduction-diabetic-foot-ulcer-size-4-weeks-a-predictor-healing-12-weeks

SOURCE StimLabs