Protocolized Foot Exercises Help in Improvement of Diabetic Foot Ulcers and Quality of Life When Added to Standard Therapy-A Randomized Clinical Trial.

Abstract

Diabetic foot disease is the major cause of nontraumatic limb amputations worldwide causing a high socioeconomic and psychological toll and a huge burden to the healthcare system. Currently, standard treatment of diabetic foot ulcer is through multidisciplinary therapy. Foot exercises have been shown to improve healing in diabetic ulcers although evidence is limited and applicability is non-uniform. Our study aimed to generate more evidence regarding the benefit of addition of protocolized foot exercises so that it can be instituted as a standard of care. It was an open label Randomized controlled trial with seventy-two patients and study duration of one and half years Patients with diabetic foot ulcers were randomized into two groups. Both groups received standard therapy for diabetic foot ulcer. The intervention group in addition received three months of protocolized foot exercises. At the end of three months ulcer healing and quality of life were m compared among both the groups. Regular exercises for three months caused significant reduction in ulcer area compared to the non-intervention group [100% versus 45.22%, 95% CI =36.30(16.04-56.56), P-value = 0.001]. Quality of life analyzed by SF-36 score showed significant improvement in components like physical function [69.4 ± 8.9 versus 63.7 ± 11.0, 95% CI = 5.73 (0.97-10.48), P-value = 0.01], emotional well-being [65.2 ± 7.6 versus 60.8 ± 7.9, 95% CI = 4.44 (0.79-8.10), P-value = 0.01], and pain components [55.4 ± 18.5 versus 47.5 ± 14.5, 95% CI = 7.99 (0.16-15.81), P-value = 0.04) at 3 months although change in social functioning, physical health limitation, health change, energy and general health improvement were not significant. Addition of protocolized foot exercises are beneficial for patients of diabetic foot ulcers in terms of ulcer healing as well as improvement of quality of life provided compliance to exercises can be ensured.