The effectiveness of foot orthoses as a treatment for plantar ulceration in leprosy : a study of the efficacy, acceptability, appropriateness and implantation of a podiatric regimen

This was a holistic study. Four themes were investigated to demonstrate the effectiveness of orthotic intervention for plantar ulceration affecting leprosy impaired subjects in India. 1. Efficacy Efficacy was demonstrated, primarily, through analysis of data pertaining to a controlled trial. Thirty-seven subjects, presenting with leprosy impairments including anaesthesia and plantar ulceration, were fitted with orthoses and allocated to an experimental group. Thirty-four similar subjects, were not offered orthoses and were allocated to a control group. After 8 months 52% of the ulcers presented by Experimental group and 12% of the ulcers presented by the Control group had healed. The rationale supporting the prescription of orthoses was investigated using the EMED system. It was demonstrated that intervention with orthoses resulted in significantly lower sub pedal peak pressures than intervention with leprosy sandals. 2. Implementation and Sustain ability Ulcer assessment data from March 1994 to January 1995 were used to compare the effects of orthoses supplied by the investigator with orthoses supplied by an Indian technician. The service, evaluated on the strength of these findings, was considered to have been successfully implemented. The analysis of data, collected from January 1995 to December 1995, was used to explain why the service was not sustained at an acceptable level. 3. Acceptability Interview data were analysed to describe the attitudes of the subjects to the intervention (n = 46). Indications from the analysis were that neither ulcer status (healed or unresolved) nor group allocation (Experimental or Control) affected attitudes towards the intervention. A general indication was that the intervention was favourably endorsed. 4. Appropriateness Using the Delphi technique (n = 10), a consensus on indicators of "appropriate" impairment control measures was sought. Differences of opinion were not resolved, but group priorities were ranked and a polled response was recorded. The results of the study were similar to the criteria suggested by the Delphi contributors