Validation and comparison of currently available stratification systems for patients with diabetes by risk of foot ulcer development

Abstract

Aims/hypothesis: There are five systems to stratify the risk for the development of a diabetic foot ulcer (DFU). This study aimed to prospectively validate all of them in the same cohort of participants to allow their direct comparison. Methods: A retrospective cohort study was conducted on all patients with diabetes but without an active DFU attending our podiatry section (nZ364) from January 2008 to December 2010. Participants' characteristics and all variables composing the stratification systems were assessed at baseline. Follow-up was performed for 1 year or until DFU occurred. Results: Participants had a mean age of 64 years; 99.7% had type 2 diabetes and 48.6% were male. Median follow-up was 12 months (1-12) during which 33 subjects (9.1%) developed a DFU. Age, diabetes duration, foot deformity, peripheral vascular disease, diabetic peripheral neuropathy, previous DFU, and previous lower extremity amputation were associated with DFU occurrence. All systems presented greater DFU occurrence frequency as the risk group was higher (c 2 , P!0.001) and showed good diagnostic accuracy values, especially negative predictive value (R95%) and area under the receiver operating curve (R0.73). The lowest performance concerned positive predictive value (%29.5%). Conclusions/interpretation: All the currently available stratification systems show high accuracy to detect which patients will develop a DFU with no significant differences among them. Therefore, for diabetic foot screening and resource allocation, it would be desirable to have a single unified system, combining the available systems, prospectively validated in a multicenter context and testing the inclusion of novel predictive variables' pertinence.

A new diabetic foot risk assessment tool: DIAFORA

“…Taking into consideration the results of our group's previous systematic reviews and validation studies , we believe that diabetic foot risk assessment has great potential for improvement. And so, before creating a new classification, we considered refining one of the existing classifications for the LEA prediction.…”

“…The new classification, DIAFORA, included four foot and four DFU features. For the first part, we have chosen to include the variables already used by the IWGDF and American Diabetes Association to facilitate the adoption of this tool by health professionals in their clinical practice . While for the last, because of a lack of consensus , we decided to use statistical methods to identify the most pertinent from those already included in the available systems.…”

“…In the two existing studies comparing each kind of classification among themselves, no statistically significant differences were observed, and opportunities for improvement were reported, especially with regard to low positive predictive values.…”

Diabetic foot risk assessment

“…This High Risk Diabetic Foot: A 60-Second Tool (2012)© tool has been tested for reliability and clinical utility [10]. In addition to these tools, many classification systems exist, and these have been welldescribed and compared by Monteiro-Soares et al [11]. However, to determine risk and categorize individual patients, clinicians need a pencil-and-paper or an electronic form.…”

Prevalencia moderada de pie en riesgo de ulceración en diabéticos tipo 2 según IGWDF en el contexto de la atención primaria

“…Debido a este enorme problema para categorizar los riesgos que llevan al pie diabético, se utilizan sistemas de diagnósticos tales como la Scottish Intercollegiate Guideline Network (SIGN), la ADA (American Diabetes Association), la NHS (National Health Service) Borders Foot Classification System y la International Working Group on the Diabetic Foot (IWGDF); esta última, la más aceptada por consenso mundial (5,6) .…”