Grant: Operating Grant: SPOR Innovative Clinical Trial Multi-Year Grant

Diabetic foot ulcer (DFU) is a major complication of diabetes and can be a significant physical, social, financial and emotional burden. About 25% of persons with diabetes develop DFUs. If poorly managed, DFUs can lead to amputations, 1 of the 2 most feared complications of diabetes. The risk of DFUs can be reduced with simple preventative measures yet DFUs and DFU relapses have not declined as there is no high-quality data supporting proactive DFU treatment. Chiropodists are experts at managing foot disorders. A small study linked chiropodist care with markedly less leg amputations in people with diabetes and on dialysis. This led us to think that an intensive, structured, chiropodist-led strategy will lower amputation-related hospitalizations in those with diabetes and their need for medical, social and financial resources. In consultation with persons with diabetes, amputees and representatives from health agencies, and diabetes and DFU professional groups, we designed a novel trial to study if chiropodist care will lower amputation-related hospitalizations in those with diabetes undergoing dialysis since this group is deemed to have the greatest need and is one that administrators are most likely to effect change in funding allocation and health care systems delivery. Our study will include 2200 participants from 40 sites in Ontario, Alberta and Manitoba. The 2-year study will record amputation-related hospitalizations, deaths, cost effectiveness and perceived quality of life. Our committee includes persons with diabetes, amputees, chiropodists, a nurse, a family doctor and specialists. We have trial experts, a health care economist and statisticians who will assist in data interpretation, and individuals in the government and professional groups who will provide guidance on rolling out the findings (if positive) into clinical practice. Finally, the trainees will receive hands on experience to enrich their expertise as they carve out their career paths.