Effectiveness of offloading methods in preventing primary diabetic foot ulcers in adults with diabetes: a systematic review.

BACKGROUND: The incidence of foot ulceration related to diabetes is increasing. Many foot care professionals recommend offloading measures as part of management strategies for modulating excess pressure to prevent development of diabetic foot ulcers (DFUs). These measures may include padding, insoles/orthotic devices and footwear. There is a lack of evidence-based guidance on the effectiveness of the different offloading options for preventing primary ulceration in those with diabetes.

OBJECTIVES: To identify, critically appraise and synthesize the best available evidence on methods of offloading to prevent the development, and reduce the risk, of primary foot ulceration in adults with diabetes.The question addressed by the review was: what is the effectiveness of methods of offloading in preventing primary DFUs in adults with diabetes?

INCLUSION CRITERIA TYPES OF PARTICIPANTS: Adults 18 years and older with diabetes mellitus, regardless of age, gender, ethnicity, duration or type of diabetes, with no history of DFUs and in any clinical setting will be included.

TYPES OF INTERVENTIONS AND COMPARATORS: Interventions will include all external methods of offloading. All comparators will be considered. Studies that utilize interventions not considered usual practice in the prevention of DFUs will be excluded.

OUTCOMES: The primary outcome will be primary foot ulceration. The secondary outcome will be indications of changes in plantar pressure.

TYPES OF STUDIES: This review will consider all quantitative study designs.

SEARCH STRATEGY: A three-step strategy for published and unpublished literature will be used. Fourteen databases will be searched for studies in English up to November 2013.

DATA EXTRACTION: The JBI-MAStARI extraction tool was used to extract relevant data.

DATA SYNTHESIS: Results were summarized using narrative and tables.

RESULTS: Three studies which examined the effectiveness of four different offloading interventions met the inclusion criteria. There is limited evidence that use of a footwear system (prototype shoe plus polyurethane or cork insole) may prevent a break in the skin; use of customized rigid orthotic devices may contribute to a reduction in the grade and number of calluses; and a manufactured shoe plus customized insole may reduce plantar pressure and therefore reduce the potential risk of skin ulceration.

CONCLUSION: There is limited and low-quality evidence that in a population of adults with diabetes with no history of DFU, the use of footwear with customized or prefabricated orthotic devices may provide some reduction in plantar pressure and therefore help to prevent a primary DFU. There is a lack of evidence on the relative effectiveness of different offloading options.