126-LB: Evaluation of the Efficacy of the Therapeutic Agent Cytoreg in Patients with Diabetic Foot: A Clinical Humanitarian Protocol

Abstract

Diabetic foot wound complications, including bacterial infections, ulcerations, and gangrene, are a major cause of hospitalizations and account for 85% of diabetic amputations. The investigational therapeutic agent Cytoreg®, an aqueous mixture of hydrofluoric, hydrochloric, sulfuric, phosphoric, phosphoric, citric, and oxalic acids, was recently shown to increase arterial oxygen levels in an orally administered Wistar rat model. It previously demonstrated bactericidal effect. Under a compassionate use protocol, we tested oral and topical treatment with diluted Cytoreg in patients with diabetic foot ulcers in a 30-day study in Venezuela. The total study population was ten patients under informed consent. On average, all patients received oral Cytoreg daily for 30 days. Five patients received oral Cytoreg plus topical wound cleansing with Cytoreg in isotonic saline. In addition to standard clinical observations, wound healing was monitored using the St. Elian’s checklist system. Four of five patients in the oral plus topical group had complete closure of their wounds after thirty days. Two of the patients in the oral group had complete wound closure. There was no significant change in oxygen saturation in the affected tissues, nor in insulin and glycemia levels. However, there were significant increases in arterial hemoglobin and arterial oxygen-pO2- were observed. Significant decreases HbA1c, aspartate aminotransferase, glutamic-pyruvic transaminase, creatinine, and urea levels were also observed. The overall results are encouraging and justify an expanded study in the treatment of diabetic foot wounds. Disclosure D. A. Carrillo: Research Support; Self; Cytorex Biosciences Inc. K. Villasana: None. G. Torres: Research Support; Self; Cytorex Bioscience Inc. L. J. Pozo: None. W. J. Jimenez: Board Member; Self; Cytorex Biosciences Inc. W. E. Bauta: Advisory Panel; Self; Cytorex Biosciences, Vascular Perfusion Solutions, Employee; Self; bioAffinity Technologies. L. Dugarte: None.