StimLabs® Announces IRB Approval for CAMPSTIM: The Largest Prospective Placental Tissue Allograft Trial for Diabetic Foot Ulcers

• First diabetic foot ulcer (DFU) study in the US utilizing a modified platform trial design to demonstrate the efficacy of multiple products in a single clinical trial.
• First to incorporate continuous glucose monitoring in a cellular, acellular, matrix-like product (CAMP) DFU study

ROSWELL, Ga., June 4, 2024 /PRNewswire/ -- StimLabs, a leading regenerative medicine company, announced Institutional Review Board (IRB) authorization to begin the CAMPSTIM clinical trial, a multi-center randomized controlled trial to demonstrate the real-world benefits of StimLabs' placental-based tissue products in treating patients with hard-to-heal diabetic foot ulcers (DFUs).

"This trial is the first US master trial design in non-healing DFU studies to demonstrate the efficacy of multiple products in a single trial, the first DFU trial to utilize 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 for the trial. He added, "This platform, and 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 the United States, DFUs occur in 1.6M patients with diabetes annually¹. These ulcers commonly recur and often lead to severe complications such as skin and soft tissue infections, osteomyelitis, amputation, sepsis, and death. The longer a DFU remains open, the greater the risk of complication.² Despite advances in treatment, less than 50% of DFUs are healed at 12 weeks.³ Additionally, greater than 90% of DFUs with less than a 50% area reduction at 4 weeks of standard of care (SOC) do not go on to heal.⁴ These alarmingly poor healing rates highlight the need for effective CAMPs, also known as skin substitutes, in patients suffering from DFUs.

"In collaboration with SerenaGroup, we have carefully designed a comprehensive and standardized trial utilizing advanced technologies to ensure the highest quality results," said John Daniel, Founder and CEO of StimLabs. The CAMPSTIM trial features a protocol that will drive consistency across sites through the inclusion of digital devices to provide wound measurements and bacterial load and the incorporation of continuous glucose monitoring for every patient. Furthermore, 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 fibre dressing, Exufiber® in highly exudating wounds.

CAMPSTIM will evaluate at least four separate StimLabs CAMPs (Enverse®, Revita®, Relese® and Cogenex®) with SOC compared to SOC alone, in treating patients with non-healing DFUs. The study utilizes a unique modified platform trial design, adapted from clinical trials developed during the pandemic to test multiple interventions within a single trial.  It is the first such design used for DFUs in the US. As the largest planned prospective clinical study to date on placental tissue allografts, CAMPSTIM will enroll approximately 272 patients across multiple sites in the US.

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 of wound area reduction, number of adverse events, and changes in pain and quality of life.

"This highly vulnerable patient population will benefit greatly from the best technologies to support their wound care. Through this novel trial, we look forward to showcasing the power of our unique placental tissue allograft portfolio," said John 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 intermediate layer.  This is made possible using the patented Clearify® technology, which preserves the integrity of the membrane by ensuring it remains intact during processing.  By never delaminating the tissue, StimLabs grafts result in complete, full-thickness products which retain the essential structural proteins and growth factors that play a crucial role in wound resolution. 

About StimLabs
StimLabs LLC's mission is to advance the state of regenerative medicine, with a current focus in wound care and surgical applications. Comprised of industry leaders, StimLabs is dedicated to offering patients the best possible care while recognizing the urgency of providing solutions in areas with unmet needs. StimLabs has a comprehensive product portfolio addressing various clinical applications and has established a strong intellectual property catalog. Committed to delivering superior products, StimLabs is a trusted partner to physicians and patients alike. https://stimlabs.com.

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

Media Contact:
StimLabs
[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 3February2024.

3.  Fife CE, Eckert KA, Carter MJ. Publicly Reported Wound Healing Rates: The Fantasy and the Reality. Adv Wound Care (New Rochelle). 2018 Mar 1;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 by 12 Weeks. (2010). Wound Management & 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