Wound Healing In Diabetes (WHy) Study

• Conditions: Impaired Wound Healing; Diabetes Mellitus

• Registration Number: NCT01002521
• Lead Sponsor: The University of The West Indies

Brief Summary

This observational study aims to identify risk factors and molecular mechanisms of impaired wound healing, to guide better foot care in the diabetic population.

Detailed Description

Diabetes is linked with vascular complications of the eye, kidney and foot. Barbadians suffer from an unusually high prevalence of diabetic foot complications, which can cause difficult-to-heal foot ulcers and even lead to amputations of the toes or feet.Studies from the CDRC have indicated alarmingly high rates of amputation and mortality due to diabetic foot in Barbados. The goal of this study is to improve early detection of persons at risk of the vascular complications of diabetes through non-invasive scanning and genetic susceptibility tests.

The general hypothesis to be tested in this study is that persons with diabetes (PWD) and non-healing foot ulcers are more likely to have a disturbed mechanism for wound-healing than PWD without this particular complication. If the hypothesis is proven correct, this will empower patients and physicians with the diagnostic tests to make early interventions towards avoiding the complications of diabetes.

Study Timeline

• Status Verified: 2009-10
• Study First Submitted: 2009-10-23
• Study First Submitted QC: 2009-10-26
• Last Update Submitted: 2009-10-26
• Study First Posted: 2009-10-27
• Last Update Posted: 2009-10-27
• Study Start: 2009-12
• Primary Completion: 2011-06
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 605

Inclusion Criteria

• clinical diagnosis of diabetes
• Barbadian national
• self reported ethnicity of Black/African descent
• clear knowledge of ulcer history

Exclusion Criteria

• no clinical diagnosis of diabetes
• non-national of Barbados
• self reported ethnicity not Black/African Descent
• unclear knowledge of ulcer history

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Genetic Phenotyping (Haptoglobin and TRAPS)	18 months

Secondary Outcome Measures

Name	Time	Method
Reactive Hyperemia Index and Augmentation Index	18 months
Depression	18 months
Quality of Life	18 months

Trial Locations

Locations (1)

Chronic Disease Research Centre; 🇧🇧 Bridgetown, St Michael, Barbados