TEL AVIV, Israel and JACKSONVILLE, Fla., Sept. 03, 2024 (GLOBE NEWSWIRE) -- RedDress®, developers of the ActiGraft® Pro system, a personalized and autologous wound care solution created from a patient’s own whole blood, today announced that ActiGraft Pro demonstrated exceptional efficacy in facilitating healing for chronic neuropathic foot ulcers in a recent, multinational randomized controlled trial.
The study, “A Multicenter, Prospective, Randomized, Controlled Trial Comparing the Safety and Efficiency of Autologous Whole Blood Clot to Standard of Care in Patients with Chronic Diabetic Foot Ulcers,” was published in the September 2024 issue of Journal of Wound Care. The study compared ActiGraft Pro against the best practice standard of care for treating chronic neuropathic diabetic foot ulcers. ActiGraft Pro showed significant superiority, with 2.73 greater odds of reaching complete wound closure (per the FDA definition) by week 12 in the treatment group compared to the control.
The ActiGraft Pro treatment resulted in a 51% healing rate compared to 18% in the control group. It also showed a shorter time to heal and greater durability of wound closure. In the follow-up phase, 71% of healed wounds in the ActiGraft Pro group remained closed compared to 55% in the control group.
“Diabetic foot ulcers not only affect the patient’s quality of life, but they are also often deadly,” said Alon Kushnir, CEO and Co-Founder of RedDress. “This study clearly shows that ActiGraft Pro improves healing rates for one of the most difficult wounds to treat successfully. We believe this further solidifies autologous blood-derived products as the future of wound care, with ActiGraft Pro the leading solution in the category.”
Each patient was treated weekly with either ActiGraft Pro plus debridement and offloading, or by the best practice standard of care that includes debridement, alginate or hydrogel dressing, and offloading. Complete healing was defined as 100% closure with no drainage, and patient treatment methodology was blinded to the study’s central, independent wound assessor. The study included 119 patients at 13 sites in the US, three sites in South Africa and one site in Turkey.
“The ActiGraft trial was conducted with the utmost rigor, adhering to the highest standards of trial design and execution,” said the trial’s Lead Principal Investigator Robert J. Snyder, DPM, MSc, MBA, CWSP, FFPM RCPS(Glasgow), Professor and Director of Clinical Research, Barry University School of Podiatric Medicine. “The rigorous run-in period and adherence to best practice standards in the control arm ensured a robust comparison between the whole blood clot and standard care. The findings confirmed the superior efficacy of the whole blood clot in treating difficult-to-heal diabetic foot ulcers compared to standard treatments, reflecting its immense value in wound care.”
Diabetic foot ulcers (DFUs) pose a significant social and economic burden in the US and globally, with Medicare incurring nearly $4 billion in DFU-related costs in 2019.1 The mortality rate among DFU patients is twice as high as that of diabetic patients without DFUs.2
The ActiGraft Pro system is an autologous, point-of-care wound management solution created from a patient’s whole blood. Once applied, the blood clot serves as a protective covering and optimizes the body’s own healing potential. ActiGraft Pro is designed to jump-start wound healing and to meet the needs of today’s high-volume practices and centers, offering practitioners a wound healing solution that delivers a quick and easy procedure. Applied directly to the wound surface, the ActiGraft Pro blood clot is created at the patient’s bedside in under five minutes by mixing fresh whole blood with proprietary coagulation powder. ActiGraft Pro contains whole blood cells including white cells, red cells, plasma, platelets, and fibrin, in the optimal concentration required in the wound healing process. Once applied, ActiGraft Pro reignites the healing cascade, serving as a protective covering that supports wound healing processes which occur naturally in the body.
While reimbursement for ActiGraft Pro currently applies only to chronic wounds in diabetic patients via national coverage determination 270.3, ActiGraft Pro is indicated for a wide variety of chronic wounds including but not limited to: Diabetic and Neuropathic Ulcers, Venous Ulcers, Traumatic Wounds, Post-Surgical Wounds, Skin Tears and Surgical Wounds.
Since RedDress received FDA clearance and a CE Mark in 2020, ActiGraft has helped over almost 7,000 patients across the spectrum of healthcare facilities in the United States and 30 other countries.
Disclaimer: The information provided shall not be constructed as a statement, promise, or guarantee that reimbursement will be received. Reimbursement requirements are subject to change at any time. Check with your local payer regularly.
About RedDress®
RedDress is the leading provider of personalized and autologous wound management solutions created from a patient’s own blood. The company’s suite of ActiGraft® products are transforming wound care, treating a wide variety of chronic wounds including diabetic and neuropathic ulcers, venous ulcers, pressure injuries, traumatic wounds, post-surgical wounds, skin tears, surgical wounds and more. RedDress is a privately held, Israel-based company with a U.S. subsidiary, RedDress Inc., located in Jacksonville, Florida. Founded in 2009 with the goal of developing more effective, natural, and economically viable treatments for chronic wounds, RedDress is dedicated to using its whole-blood technology to find solutions to other human ailments. www.reddressmedical.com.
- Carter MJ, DaVanzo J, Haught R et al. Chronic wound prevalence and the associated cost of treatment in Medicare beneficiaries: changes between 2014 and 2019. J Med Econ 2023; 26(1):894–901. https://doi.org/ 10.1080/13696998.2023.2232256.
- Hirpa D, Bekela T, Abdissa D. Prevalence of diabetic foot ulcer and its associated factors among diabetes patients on follow up at public hospitals in West Shewa Zone, Oromia, Ethiopia. Int J Afr Nurs Sci 2023; 19:100578. https://doi.org/10.1016/j.ijans.2023.100578.
