Begin main content

Removable Off-Loading Devices for Diabetic Foot Ulcers: A Review of Clinical and Cost-Effectiveness

Published on: September 30, 2014
Project Number: RC0579-003
Product Line: Rapid Response
Research Type: Devices and Systems
Report Type: Summary with Critical Appraisal
Result type: Report

Report in Brief

Context
Type 2 diabetes is a chronic disease characterized by high blood glucose. The estimated prevalence of diabetes in Canada is 6.8% — roughly 2.4 million Canadians — and it is increasing, with a 230% increase from 1998. Diabetic foot ulcer (DFU) is the most common chronic complication, affecting 4% to 10% of patients with diabetes. Predisposing factors include long disease duration, trauma, infection, poor glycemic control, improper footwear, advanced age, smoking, and lower socioeconomic status. However, neuropathy and peripheral vascular disease are the most significant risk factors. DFU complications include wound infection, osteomyelitis, cellulitis, and amputation, and can lead to significant morbidity, mortality, and health care costs.

Technology
High plantar pressure — pressure on the bottom of the foot from the surface below — can increase the risk of DFUs. Devices that off-load and reduce the plantar pressure are used in their prevention and treatment. These off-loading devices include removable options such as cast walkers and orthoses (sometimes called orthotics), or devices that can't be removed by patients such as total contact casting (requiring a skilled technician) and instant total contact casting (making a removable walking cast permanent by wrapping it in casting material).

Issue
Off-loading devices can impact patient mobility, potentially limiting their use and effectiveness. A review of the clinical effectiveness of removable and non-removable off-loading devices, a comparison of their effectiveness, and a review of their comparative cost-effectiveness will help to inform decisions about the treatment and prevention of DFUs.

Methods
A limited literature search was conducted of key resources, and titles and abstracts of the retrieved publications were reviewed. Full-text publications were evaluated for final article selection according to predetermined selection criteria (population, intervention, comparator, outcomes, and study designs).

Results
The literature search identified 299 citations, 21 of which were deemed potentially relevant. An additional 3 reports were retrieved from other sources. Of these 24 reports, 10 met the criteria for inclusion in this review: 3 systematic reviews, 6 randomized controlled trials, and 1 economic analysis.

Key Messages

  • The non-removable off-loading devices — total contact casting and instant total contact casting — appear to be more effective than removable devices in the treatment of DFU.
  • Of the removable off-loading devices, cast walkers may be the most effective in the treatment of DFU.
  • It is uncertain which devices are most effective for DFU prevention.
  • Cost-effectiveness evidence was limited but suggests soft-heel casting may be more cost-effective than orthotic boots for DFU prevention and treatment.

Question

  1. What is the clinical effectiveness of removable orthoses for the prevention or treatment of diabetic foot ulcers?
  2. What is the clinical effectiveness of total contact casting for the prevention or treatment of diabetic foot ulcers?
  3. What is the comparative clinical effectiveness of removable orthoses versus total contact casting for diabetic foot ulcers?
  4. What is the cost-effectiveness of removable orthoses versus total contact casting for the prevention or treatment of diabetic foot ulcers?

Key Message

Conflicting evidence was identified to support diabetic shoes and customized footwear with customized removable orthoses for clinically effective prevention of diabetic foot ulcers in high-risk patients. One systematic review found that removable cast walkers are the most clinically effective removable off-loading device for the treatment of diabetic foot ulcers. All of the relevant identified evidence - two systematic reviews and one randomized controlled trial - supports total contact casting and instant total contact casting for providing clinically superior treatment outcomes for diabetic foot ulcer patients compared to all other examined devices. No evidence was identified for the prevention of diabetic foot ulcers using total contact casting. One cost-effectiveness analysis, based upon limited evidence, was identified that estimated soft-heel casting offers cost savings over orthotic boots for both treatment and prevention of diabetic foot ulcers.

Tags

walkers, diabetic foot, orthotic devices, wounds and injuries, casts, surgical, diabetes, offloading, orthotics, total contact casts, total contact cast, walker, Casts, Surgical