Newly published data from a multicenter randomized controlled trial in diabetic foot ulcers confirms ActiGraftPRO provides greater odds of reaching complete wound closure by week 12 compared to standard of care.1
ActiGraftPRO heals 2.83 times faster than standard of care
Study Overview
The study, “A Multi Center, Prospective, Randomized, Controlled Trial, Comparing the Safety and Efficacy of ActiGraftPRO to Standard of Care in Patients with Chronic Neuropathic Diabetic Foot Ulcers,” (NCT04185558) included 119 patients at 16 sites across the world. Results were recently published in the Journal of Wound Care.
Rigorous Methodology
The ActiGraftPRO clinical trial was conducted with utmost rigor, adhering to the highest standards of trial design and execution.
An independent remote blinded assessor reviewed all images for healing and measurement accuracy by tracing validation.
The Future of Wound Care for Hard-to-Heal Diabetic
Foot Ulcers (DFUs)
ActiGraftPRO is an autologous blood clot, point wound management solution created from your patient’s whole blood. Once applied, the blood clot serves as a protective wound covering and optimizes the body’s own healing potential.
Superior healing outcomes
ActiGraftPRO had a 41% healing rate in the intention-to-treat (ITT) population vs. 15% in standard of care (SoC).
ActiGraftPRO healed 51% of DFUs in the per-protocol (PP) population vs. 18% in standard of care.
Complete Wound Closure (ITT) Population
Complete Wound Closure (PP) Population
Wound closure rate intention-to-treat (ITT) population and per-protocol (PP) population.
Kaplan-Meier plot ITT population (a), Kaplan-Meier plot, PP population (b). Lines are shown for treatment (ActiGraftPRO) and standard of care (control) after adjusting for contribution of other significant variables.
Greater durability of wound closure
71% of wounds remained healed following ActiGraftPRO vs. 55% in control after 12 weeks.
Shorter time to heal
Patient with type 2 diabetes, congestive heart failure and other conditions presented with a hard-to-heal DFU of 14 months (a). The wound closed 11 weeks after ActiGraftPRO weekly application (b).
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Reference 1. Snyder R, Nouvong A, Ulloa J, et al. Efficacy and safety of autologous whole blood clot in diabetic foot ulcers: a randomised controlled trial. Journal of Wound Care. 2024; Published Online: 30 Aug 2024. https://doi.org/10.12968/jowc.2024.0195