A systematic review 4 41 studies of which 6 were meta-analyses, 26 RCTs 13 other controlled studies, and 120 non-controlled studies. 5 meta-analyses and 12 RCTs provided high-quality evidence for non-removable knee-high offloading devices being more effective than removable offloading devices and therapeutic footwear for healing plantar forefoot and midfoot ulcers. Total contact casts (TCCs) and non-removable knee-high walkers were shown to be equally effective. Removable knee-high and ankle-high offloading devices were equally effective in healing, but knee-high devices have a larger effect on reducing plantar pressure and ambulatory activity (moderate quality evidence). Low-quality evidence exists for the use of felted foam and surgical offloading to promote healing of plantar forefoot and midfoot ulcers.
A Cochrane review [Abstract] 1 included 14 studies with a total of 709 subjects. One study compared two different types of non-removable casts with no discernable difference between the groups. 7 studies (n=366) compared non-removable casts with removable pressure-relieving devices. Non-removable casts were associated with a statistically significant increase in the number of ulcers healed compared with the removable device (RR 1.17, 95% CI 1.01 to 1.36; 5 studies, n=230).Two studies (n=98) found that significantly more ulcers healed with non-removable casts than with dressings alone. Achilles tendon lengthening combined with a non-removable cast in one study resulted in significantly more healed ulcers at 7 months than non-removable cast alone (RR 2.23, 95% CI 1.32 to 3.76). More ulcers remained healed at two years in this group (RR 3.41, 95% CI 1.42 to 8.18).Other comparisons included surgical debridement of ulcers; felt fitted to the foot; felted foam dressings and none of these showed a statistically significant treatment effect in favour of the intervention.
A systematic review 2 included 2 systematic reviews and meta-analyses, 32 randomized controlled trials, 15 other controlled studies, and another 127 non-controlled studies. Several randomized controlled trials with low risk of bias showed the efficacy of therapeutic footwear that demonstrates to relief plantar pressure in the prevention of plantar foot ulcer recurrence. 2 meta-analyses showed non-removable offloading to be more effective than removable offloading for healing plantar neuropathic forefoot ulcers.
An observational study 3 evaluate the effect of different protective off-loading devices on healing and postoperative complications in diabetic foot patients following limb preservation surgery (n=127). The lowest number of postoperative complications (number of reamputations: p = 0.028; rehospitalizations: p = 0.0085; and major amputations: p = 0.02) was in group wheelchair+removable contact splint compared to groups wheelchair only and, and wheelchair+removable prefabricated device. There was a strong trend toward a higher percentage of healed patients (78.4% vs. 55.7% and 65.5%; p = 0.068) over a shorter duration (13.7 vs. 16.5 and 20.3 weeks; p = 0.055) in the wheelchair+removable splint group.
Comment: The quality of evidence is downgraded by study limitations (unclear allocation concealment and blinding).
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