, /PRNewswire/ -- StimLabs , a leading regenerative medicine company, announced enrollment of the first patient in CAMPSTIM, a multi-center randomized controlled trial to demonstrate the clinical outcomes of StimLabs' placental-based tissue products with standard of care (SOC) compared to SOC alone, in patients with hard-to-heal diabetic foot ulcers (DFUs). This first patient was enrolled at Tulsa Wound Center by Dr. Lam Le.
CAMPSTIM employs a novel, modified platform clinical trial design, marking the first application of such a methodology for DFUs in the US. Evaluating at least four separate StimLabs cellular, acellular, and matrix-like products (CAMPs) – , Revita , Enverse , and Relese - the study is managed by the highly experienced SerenaGroup , led by , MD, FACS, FACHM, MAPWCA. 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 scores. "This trial will validate the benefits of our technologies in supporting patients' wound resolution when added to standard of care, and enrollment points to the continued progress of the study," said , Founder and CEO of StimLabs.
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