Reliability of a Diabetic Foot Ulcer Risk Stratification and Referral Algorithm

Foot Ulcer, Diabetic Clinical Trial

Official title: Reliability of a Diabetic Foot Ulcer Risk Stratification and Referral Algorithm

Status Completed

Clinical Trial Summary

The main objective of this research study is to validate the St Joseph's Health Care Harmonized Foot Ulcer Assessment and Stratification tool using inter-rater reliability technique to determine if the score would consistently be reproducible by examiners of different role (Nurse Practitioner, Family physician, Registered Nurse and Resident). A validated assessment tool allows collecting better quality data with high comparability which enhances quality of foot care and increases the credibility of the tool.

Clinical Trial Description

Diabetes mellitus (DM) is a chronic disease characterized by the human body's inability to maintain appropriate blood glucose levels ( Buse et al. 2011). When inadequately managed, diabetes results in poor glycemic control, which, if prolonged, results in diabetes-related complications (Stratton et al. 2000). Diabetes is the major cause of blindness, kidney failure, and non-traumatic amputation in Canadian adults (PHAC, 2011). Foot ulcers are the major causes of amputations. Foot ulcers arise from poor circulation associated with peripheral vascular disease and neuropathy, injury and infections. Diabetes affects circulation and immunity, and over time the sensory nerves in the hands and feet may be damaged.

There are more than 2.4 million Canadians living with diabetes, of which 1.2 million of them live in Ontario (MHLTC). Diabetes is the leading cause of non-traumatic lower limb amputation in Canadian adults, associated with approximately 70% of amputations performed in hospital. Compared to the general population, Canadian adults with diabetes are over 20 times more likely to undergo non-traumatic lower limb amputations, 85% of which are preceded by a foot ulcer (PHAC, 2011 and Singh et al.,2005). According to a recent report (CDA, 2016) commissioned by the Canadian Diabetes Association (CDA), of the 1.53 million people with diabetes in Ontario, between 16,600 and 27,600 were expected to have a diabetes foot ulcer in 2015. Of these, nearly 2,000 were expected to need to have a lower limb amputated as a result of their condition and those amputations are associated with almost 800 premature deaths. In Ontario, diabetic foot ulcers (DFU) currently impose direct health-care costs of between $320-400 million and indirect costs of between $35-60 million (Hopkins et al.,2015).

Strong evidence shows that up to 85% of diabetic foot amputations can be prevented, supporting the benefits of early recognition of diabetes-related foot complications (CDA, 2013). Furthermore, timely assessment, referral, and provision of evidence-informed foot care are cost saving for the healthcare system. Use of a standardized diabetic foot assessment tool is required to ensure consistent approach to risk recognition and provide a framework for care. In response to the need for a tool that facilitates a consistent and standard screening procedure, the Primary Care Diabetes Support Program (PCDSP) at St. Joseph's Health Care, London, Ontario developed an evidence based, multi-disciplinary foot ulcer assessment tool. The SJHC harmonized foot ulcer assessment tool was developed to aid in the early detection of diabetic foot problems and to ensure prompt referral to the right foot care provider for appropriate treatment, thereby improving outcomes of the diabetic foot. ;

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic
• Ulcer

• NCT number: NCT03370237
• Study type: Observational
• Source: Lawson Health Research Institute
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Completion date: September 22, 2017