Reliability of a Diabetic Foot Ulcer Risk Stratification and Referral Algorithm

NCT03370237 | Completed

• 1 other identifier: 30
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Foot Ulcer, Diabetic

Keywords

Diabetic foot ulcer; type 2 diabetes; foot ulcer risk

Outcome Measures

Primary Outcomes (1)

• Diabetic foot ulcer risk score

  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.

  on examination day

Secondary Outcomes (1)

• Raters' level of confidence

  On examination day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with type 2 diabetes who have received diabetes care at the primary care diabetes support program in London Ontario, Canada.

You may qualify if:

• 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

You may not qualify if:

• Patients with previous transfemoral or transtibial amputation or diagnosed with dementia or inability to speak English were excluded from the study

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• St. Joseph's Healthcare Foundation: collaborator

Study Sites (1)

SJHC Primary Care Diabetes Support Program SJHC Family Medical and Dental Centre

London, Ontario, N6G 1J1, Canada

Location

Related Publications (8)

• Buse JB, Polonsky KS, Burant CF. Type 2 diabetes mellitus. In: Kronenberg HM, Melmed S, Polonsky KS, Larsen PR. Williams Textbook of Endocrinology. 12th ed. Philadelphia, PA: Saunders Elsevier; 2011

  BACKGROUND

• Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, Hadden D, Turner RC, Holman RR. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000 Aug 12;321(7258):405-12. doi: 10.1136/bmj.321.7258.405.

  PMID: 10938048 BACKGROUND

• Public Health Agency of Canada. Diabetes in Canada: Facts and Figures from a Public Health Perspective. Ottawa; 2011.

  BACKGROUND

• Ministry of Health and Long Term Care. Diabetes Management Strategy. Chapter 3 Section 3.03

  BACKGROUND

• Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005 Jan 12;293(2):217-28. doi: 10.1001/jama.293.2.217.

  PMID: 15644549 BACKGROUND

• Canadian Diabetes Association : Impact of offloading devices on the cost of diabetic foot ulcers in Ontario, http://www.diabetes.ca/publications-newsletters/advocacy-reports/impact-of-offloading-devices Accessed on Sep 11 2016

  BACKGROUND

• Hopkins RB, Burke N, Harlock J, Jegathisawaran J, Goeree R. Economic burden of illness associated with diabetic foot ulcers in Canada. BMC Health Serv Res. 2015 Jan 22;15:13. doi: 10.1186/s12913-015-0687-5.

  PMID: 25608648 BACKGROUND

• Canadian Diabetes Association Clinical Practice Guidelines Expert Committee; Booth G, Cheng AY. Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada. Methods. Can J Diabetes. 2013 Apr;37 Suppl 1:S4-7. doi: 10.1016/j.jcjd.2013.01.010. Epub 2013 Mar 26. No abstract available.

  PMID: 24070961 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Betty Harvey

  Western University and St Joseph's Health Care London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Associate Professor

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 12, 2017
• Study Start: July 1, 2017
• Primary Completion: September 22, 2017
• Study Completion: September 22, 2017
• Last Updated: December 12, 2017

Record last verified: 2017-12

Locations

CA (1)