Revolutionary breakthrough? New trial by StimLabs could change future of diabetic wound care

StimLabs, a pioneer in regenerative medicine, has initiated the CAMPSTIM trial, a groundbreaking multi-center randomized controlled trial aimed at assessing the effectiveness of its innovative placental-based tissue products in treating diabetic foot ulcers (DFUs). This trial, marking a significant advancement in DFU treatment methodologies, enrolled its first patient at Tulsa Wound Center, under the supervision of Dr. Lam Le.

CAMPSTIM, managed by the SerenaGroup under the leadership of Thomas E. Serena, MD, FACS, FACHM, MAPWCA, employs a novel, modified platform clinical trial design—a first for DFU treatments in the U.S. This approach allows for the evaluation of multiple StimLabs products, including Cogenex, Revita, Enverse, and Relese.

As the largest prospective clinical study on placental tissue allografts planned to date, CAMPSTIM aims to enroll approximately 272 patients across various U.S. locations. The primary endpoint is the percentage of target ulcers achieving complete closure within 12 weeks, with secondary endpoints focusing on time to closure, wound area reduction, adverse events, and improvements in pain and quality of life.

StimLabs’ CAMPSTIM trial is setting new standards in diabetic foot ulcer treatment with innovative tissue products

StimLabs has partnered with Mölnlycke Health Care, a leader in wound care solutions, to standardize the trial’s wound care protocol. Mölnlycke will provide its advanced Mepilex Border Flex dressings and, for highly exudating wounds, Exufiber dressings. This collaboration ensures that all patients receive consistent and optimal wound care throughout the study.

Diabetes affects over 38 million Americans, with 1-4% developing DFUs annually. These ulcers can lead to severe complications, including infections, amputation, and even death. The CAMPSTIM trial aims to validate the efficacy of StimLabs’ placental-based products in conjunction with standard wound care, potentially setting a new benchmark in DFU treatment.

John Daniel, Founder and CEO of StimLabs, expressed optimism about the trial’s potential, noting, “This trial will validate the benefits of our technologies in supporting patients’ wound resolution when added to standard of care.” Anders Andersson, EVP of Wound Care at Mölnlycke, also highlighted the significance of this partnership, emphasizing their commitment to enhancing patient outcomes through innovative care practices.

The success of the CAMPSTIM trial could lead to significant improvements in the treatment protocols for DFUs, offering hope and better health outcomes for millions of diabetes patients across the U.S. The medical community eagerly anticipates the results, hoping for positive outcomes that could transform the standard of care in diabetic wound management.