Abstract
Objectives: To compare the effectiveness of customized protective footwear made using computer assisted designing/manufacturing (CAD/CAM) technology and current standard micro-cellular rubber (MCR) footwear in the prevention of ulcers. Methods: A quasi-experimental study was carried at two hospitals of The Leprosy Mission Trust India, where patients with loss of sensation in the foot due to leprosy were included in the intervention (customized insole using CAD/CAM technology) or control (current standard MCR footwear with orthosis) groups. Data were collected using a structured questionnaire at baseline and at 6 and 12 months. The primary outcome was the incidence of ulcer. Results: A total of 178 patients were included in the final analysis, 81 in the intervention and 97 in the control groups. At the end of follow-up, 10 (12.3%) patients in the intervention group and 25 (25.8%) patients in the control group developed an ulcer (relative risk, 0.48, [95% CI, 0.24–0.93], p-value < 0.05). The patients' perceived rating of compliance to footwear, comfort, usefulness, participation, and activity level were higher in the intervention group as compared to the control group. Conclusion: The insole customized using CAD/CAM technology is more effective in preventing recurrent ulcers of the foot due to leprosy as compared to footwear using MCR, with increased compliance and patient perceived comfort, usefulness, participation, and activity level. The new technology used to customize the footwear is feasible.
Highlights
Leprosy can cause sensory loss including pain sensation in the feet, which need protection from recurrent ulceration and subsequent collapse of the tarsal bones, which often lead to severe foot deformity
We present the effectiveness of such footwear, referred to as customized footwear, in the prevention of ulcer recurrence as compared to current standard micro-cellular rubber (MCR) footwear
In the intervention group the orthoses were incorporated within the insole, whereas in the control group the orthoses were fitted on top of the MCR insole, as followed in current routine practice
Summary
Leprosy can cause sensory loss including pain sensation in the feet, which need protection from recurrent ulceration and subsequent collapse of the tarsal bones, which often lead to severe foot deformity. The presence of impairments such as foot drop, claw toes, intrinsic muscle wasting and loss of sweating increases the risk of ulcer.[1] The incidence of first ulcer increases the risk of subsequent ulcers.[2] The association between sensory loss in the foot and abnormal pressure distribution while walking has been well established. The sensory loss remains for the lifetime of those with permanent nerve damage and demands continuous care.[1,3] The leprosy programme has focused on drug distribution and has paid little attention to disability management, as it requires individual attention and treatment plans. A self-care programme and protective footwear using MCR and other soft insoles has been the key strategies used in the prevention of plantar ulcers.[4,5]
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