climacool adidas loading devices for the treatment of neuropathic foot ulcers in patients with diabetes
The review concluded that non removable off loading devices were more likely to result in ulcer healing than removable off loading devices for people with neuropathic foot ulcers and diabetes. Primary outcomes for safety were adverse events or complications, such as infection. Clinical effectiveness outcomes were the proportion of ulcers healed, time to healing, change in ulcer size and differences in numbers of amputations.
The included studies enrolled diabetic patients with neuropathic plantar ulcers; most patients had a forefoot ulcer location, where reported. Most patients were male and average ages ranged from 50.7 to 66.9 years, where reported. The average duration of the ulcer ranged from four weeks to 411 days and the average ulcer size ranged from 1.3cm to 587.3mm. Interventions included different types of Total Contact Cast, made to measure casts and a felted foam dressing. Comparators included a Removable Cast Walker, Darco half shoe, specialised cloth shoe, traditional dressing treatment, custom made felt shoe, Diabetic Healing shoes and OrthoWedge shoes. Intervention and control devices were often used alongside standard wound care and in some studies with instructions to limit ambulation. Further details were reported.
Assessment of study quality
Study quality was assessed using a checklist for appraisal of randomised controlled trials (RCTs) and non RCTs developed by the Scottish Intercollegiate Guidelines Network.
was performed by one reviewer and independently checked by a second reviewer.
Methods of synthesis
Studies were pooled using a random effects model (DerSimonian and Laird). Heterogeneity was quantified using .
Results of the review
Eleven RCTs and two non randomised controlled trials were included in the review (661 participants). All studies were described as average quality. Only two trials blinded outcome assessors, most studies used an intention to treat analysis and all studies gave details of patients lost to follow up. Seven studies reported adequate randomisation procedures. Participant characteristics were similar between treatment groups at baseline.
Non removable off loading devices (Total Contact Cast) were statistically significantly more effective at achieving complete healing of diabetic foot ulcers than therapeutic shoes, although there was substantial between study heterogeneity (RR 1.68, 95% CI 1.09 to 2.58; =71.5%; six studies). Five of these studies also reported a shorter time to heal with non removable off loading devices. Adverse events were generally less frequent with non removable off loading devices than comparator shoes.
There was no significant difference between non removable off loading devices and Removable Cast Walkers in terms of complete healing of the ulcer (five RCTs) although time to heal was shorter with non removable off loading devices in some studies. Adverse events were generally less frequent with non removable off loading devices than Removable Cast Walkers.
A meta analysis that compared all types of non removable devices with all types of removable devices found that non removable devices were statistically significantly more effective at achieving complete healing of the ulcer, although there was substantial between study heterogeneity (RR 1.43, 95% CI 1.11 to 1.84; =66.9%; 10 studies). Several relevant sources were searched. Language restrictions were applied so some relevant studies may have been missed. was independently checked by a second reviewer which reduced potential for error and bias; it was unclear whether study selection and quality assessment procedures were undertaken in a similar manner. The quality assessment tool appeared appropriate. Methods used to synthesise data and assess between study heterogeneity appeared generally appropriate but evidence of substantial between study heterogeneity was not investigated further.