Usefulness of a Specific Intra-necrotic Interventional Technique for the Diabetic Foot

PICHON RIVIERE, A.; AUGUSTOVSKI, F. A.; GARCIA MARTI, S.; GLUJOVSKY, D.; ALCARAZ, A.; LOPEZ, A.; BARDACH, A.; CIAPONI, A; KLEIN, K

Documento de Evaluación de Tecnologías Sanitarias

IECS

Año: 2012 p. 1 - 30

1668-2793

Diabetes has a 6% worldwide prevalence and one of its most common complications is the diabetic foot, which has a 2-16% amputation risk. Every year, more than 1 million diabetic patients suffer limb amputation worldwide, this being an avoidable complication if preventive measures and management of the diabetic foot were implemented. This report evaluates a specific intra-necrotic interventional technique for the diabetic foot created by the Argentine doctor, Elías V. Chammah. Technology This information taken only from the web page of "Fundación Personas Unidas por la Diabetes", where Dr. E. V. Chammah participates. No other data related to this procedure have been found in the extensive bibliographic search carried out. The procedure consists of a non-invasive diagnosis of the necrotic events in the diabetic foot, supported by CT images, together with a specific surgical technique that would allow the repair of certain vascularized intra-necrotic areas, in order to prevent the post-necrotic events that would lead to spontaneous or surgical amputation. Purpose The purpose of this report is to evaluate the available evidence about the effectiveness, safety and issues related with the use coverage policy of a specific intra-necrotic interventional technique (E.V. Chammah) in patients with diabetic foot and amputation indication. Methods A bibliographic search was carried out on the main databases: DARE, NHS EED, on Internet general search engines, in health technology evaluation agencies and health sponsors. Priority was given to the inclusion of systematic reviews; controlled, randomized clinical trials (RCTs); health technology assessments and economic evaluations; clinical practice guidelines and coverage policies of other health systems. Results With the above mentioned search strategy, together with an extensive search in the gray literature, no scientific publications were found about the effectiveness and safety of the intra-necrotic intervention procedure created by Dr. E.V. Chammah. Efforts were made in order to locate the files at Hospital Ramos Mejía, mentioned in the only site where information about the method was found, Fundación Personas Unidas por la Diabetes´s web page. At present these files are no longer available. The available scientific evidence regarding the currently used management of diabetic foot and gangrene is presented below. In general, the clinical practice guidelines recommend educating the diabetic patient in relation to foot and ulcer care when this could no be prevented. When ischemia develops, there are revascularization methods proven to be effective, in addition to different surgical or chemical debridement methods if there are necrotic areas which allow the removal of gangrenous areas without amputation. Besides, there is consensus to avoid amputation unless certain indications are met. The cost of the procedure is AR$74,000 (Argentine pesos, 2011). Conclusions Currently there is no scientific evidence to support the effectiveness and safety of Dr. E.V. Chammah´s intra-necrotic interventional technique for the diabetic foot as a method to prevent diabetic foot spontaneous and surgical amputations.