References
Efficacy of Cytoreg in the treatment of diabetic foot disease
Abstract
Objective:
Complications from diabetic foot wounds, including bacterial infection, ulceration and gangrene, are major causes of hospitalisation and are responsible for 85% of amputations in patients with diabetes. Given that orally administered investigational therapeutic Cytoreg (Cytorex de Venezuela SA, Venezuela), a defined aqueous mixture of hydrofluoric, hydrochloric, sulfuric, phosphoric, citric and oxalic acids, has been shown to increase levels of arterial blood oxygen in a Wistar rat model, oral and oral+topical Cytoreg were tested on patients with diabetic foot ulcers (DFUs) under a humanitarian, compassionate-use protocol.
Method:
All patients received oral Cytoreg (5.0ml concentrate in fruit juice) for 30 days; half also received weekly wound washing with Cytoreg concentrate in isotonic saline (1:50 volume/volume) (oral+topical group). In addition to standard clinical observations, wounds were monitored against the Saint Elian checklist system for the diabetic foot.
Results:
A total of 10 patients took part in the study. Complete wound closure was observed in 4/5 patients in the oral+topical group; in the remaining patient, necrotic and fibrin tissues on the wound edges were eliminated. Half (2/4) of the patients receiving oral-only Cytoreg experienced complete wound closure; one patient in this group was removed prematurely because of an unrelated illness and was not replaced. During the study, no significant differences were observed between groups in either the oxygen saturation of the affected tissues or in insulin and glycaemia levels (p<0.05). Significant increases in arterial haemoglobin and arterial oxygen partial pressure (p<0.05) were observed, and significant decreases were measured in the levels of glycosylated haemoglobin, aspartate aminotransferase, glutamic-pyruvic transaminase, creatine and urea (p<0.05).
Conclusion:
The results of this study justify an expanded clinical study for the treatment of DFUs with Cytoreg.
Disorders of the foot, such as infection, ulceration and gangrene, are frequent indications resulting in the hospitalisation of patients with diabetes. The diabetic population in the US continues to increase, with >100 million American adults currently living with diabetes or pre-diabetes.1 At the beginning of 2015, a report from the Centers for Disease Control (CDC) found that 30% of Americans (9% of the global population) had diabetes.2
Complications from diabetic foot wounds are the most common causes of non-trauma amputations of the lower extremities in the industrialised world.3 The risk of amputation of the lower extremities is 15–46-times greater in people with diabetes than in those who have never had the disease.4 Complications from diabetic foot that result in amputation begin with the formation of cutaneous ulcers. The early detection and adequate treatment of these ulcers can prevent up to 85% of amputations.3,5 Foot wound complications are also the most frequent reason for hospitalisation of patients with diabetes and represent up to 25% of all admissions due to diabetes in the US and UK.6 Over the three years post-diagnosis, the cost associated with the care of a diabetic foot ulcer (DFU) can exceed $26,000 USD.7 To help diminish the bacterial load in foot lesions and prevent long-term morbidities associated with amputations, a non-toxic and efficacious antiseptic agent that cleans the wound and eliminates bacterial contaminants without damaging healthy tissue is needed.3
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