SJHC Primary Care Diabetes Support Program SJHC Family Medical and Dental Centre
London, Ontario, N6G 1J1, Canada
NCT Number: NCT03370237
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
London, Ontario, N6G 1J1, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients with type 2 diabetes older than 18, living with diabetes for more than ten years and consented were included in the study as patient participants.
Care providers including family doctors, nurse practitioners, nurses and residents who provider diabetes care was including as care provider participants
Exclusion criteria
Patients with previous transfemoral or transtibial amputation or diagnosed with dementia or inability to speak English were excluded from the study
Time frame: on examination day
The Diabetic Foot Ulcer Assessment tool used in this study has five scores (categories) ranging from 0(low risk) to 3A (high risk). The higher the score is the higher the risk for diabetic foot ulcer. Each care provider assessed participating patients for foot ulcer and assigned a score for each. The five scores are 0, 1,2A,2B and 3A.
Time frame: On examination day
Raters (care providers) level of confidence in using the tool to assess diabetic foot and plan appropriate follow up
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06358846
Cardiovascular Diseases, Diabetes Complications
Karachi, Sindh, Pakistan
View Trial DetailsNCT04327622
Autoimmune Diseases, Bacterial Infections and Mycoses
Toronto, Canada
View Trial DetailsNCT02581488
Autoimmune Diseases, Cardiovascular Diseases
Sylmar, California, United States
View Trial DetailsNCT02451722
Cardiovascular Diseases, Diabetes Complications
Ramat Gan, Israel
View Trial Details