Local and Sustained Release of Antibiotics in the Surgical Treatment of Diabetic Charcot Foot

Reselute, Durham NC

Investigators

Abstract

Charcot Osteoarthropathy (COA), a severe complication of diabetes mellitus, often leads to destructive bone and joint degeneration, significant deformity, and increased risk of amputation. Surgical interventions for COA and other hindlimb arthropathies are frequently complicated by infections such as osteomyelitis. Chronic osteomyelitis is challenging to treat because antibiotic-tolerant bacteria often persist, resulting in frequent infection recurrence, extended recovery periods, and higher healthcare costs. This project seeks to address these challenges by developing the Reselution™ Hindfoot Intramedullary Nail (ReselutionTM HFN). This combination product integrates robust structural support with sustained local antibiotic delivery to prevent infections while stabilizing fractures and fusions. The long-term goal of this research is to improve outcomes for diabetic patients suffering from orthopedic infections and reduce the morbidity associated with COA-related complications. The goals of this project are to (1) develop a prototype of a shelf-stable prefabricated antibiotic- loaded nail (2) develop a manufacturing process for the Reselution HFN (3) complete preclinical verification testing to ensure performance standards are met, and (4) verify the device’s safety and efficacy in a large animal model. The project employs a rigorous pre-clinical research and development strategy in preparation for regulatory submission. In vitro studies will evaluate the shelf life, release kinetics, and antimicrobial efficacy of the antibiotic core, while mechanical testing will ensure the implant meets load-bearing requirements for hindfoot fusion. An established ovine model of hindlimb fusion will be used to validate the device’s radiographic outcomes and histological safety. The Reselution HFN has the potential to redefine the standard of care for high-risk patients with hindlimb arthropathies, such as COA, by combining structural stability with sustained local antibiotic delivery to reduce infection and amputation rates. By enabling faster recoveries, preserving mobility, and lowering the social and economic burden of diabetes-related complications, this innovation supports improved clinical outcomes and enhanced patient quality of life, addressing a critical need in a high-risk population.