Regenerative medicine company StimLabs said that it has enrolled the first patient in the CAMPSTIM trial for hard-to-heal diabetic foot ulcers (DFUs).
CAMPSTIM is a multi-centre randomised controlled trial. It is designed to assess the clinical outcomes of StimLabs’ placental-based tissue products in combination with standard care (SOC) versus SOC alone for patients with hard-to-heal DFUs.
The trial’s initial participant was enrolled at the Tulsa Wound Center by Dr. Lam Le.
According to StimLabs, the trial features a modified platform clinical trial design, representing the first use of such a methodology for DFUs in the US. It will evaluate at least four different StimLabs products, namely Cogenex, Revita, Enverse, and Release.
All the four products are said to offer unique cellular, acellular, and matrix-like properties.
CAMPSTIM aims to enroll around 272 patients at various sites across the US. The primary endpoint is the percentage of target ulcers that achieve complete closure within 12 weeks.
Secondary endpoints include the time to wound closure, the percentage reduction in wound area, the number of adverse events, and changes in pain and quality of life scores.
StimLabs founder and CEO John Daniel said: “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.
“The uniqueness of the CAMPSTIM trial design is recognised by the medical community, and we are pleased to work with other leaders in wound care, such as Mölnlycke Health Care.”
To support the trial, StimLabs has partnered with Mölnlycke Health Care, which will serve as the exclusive provider of wound dressings for CAMPSTIM.
This partnership ensures the standardised use of Mepilex Border Flex dressings and the addition of Exufiber for treating highly exudative wounds, providing patients with consistent treatment protocols and advanced dressing options, said StimLabs.
Mölnlycke Health Care wound care EVP Anders Andersson said: “We are excited to participate in this novel trial and that these patients will benefit from Mölnlycke’s dressings.
“As a company dedicated to pioneering radical innovation, we are happy to support the validation of an approach taking standard of care to the next level with skin substitutes which will improve clinical outcomes and benefit patients.”
