Wound Healing In Diabetes (WHy) Study

Diabetes Mellitus Clinical Trial

— WHy  

Official title:

Molecular and Genetic Analysis of Disturbed Wound Healing in Barbadians With Diabetic Foot Ulcers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01002521
• Other study ID #: CDRC-WHy-1
• Status: Not yet recruiting
• Phase: N/A
• First received: October 23, 2009
• Last updated: October 26, 2009
• Start date: December 2009
• Est. completion date: June 2012

Study information

• Verified date: October 2009
• Source: The University of The West Indies
• Contact: Andre R Greenidge, BSc
• Phone: 246) 426-6416
• Email: andre.greenidge[@]cavehill.uwi.edu
• Is FDA regulated: No
• Health authority: Barbados: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 605
• Est. completion date: June 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Impaired Wound Healing

Locations

Country	Name	City	State
Barbados	Chronic Disease Research Centre	Bridgetown	St Michael

Sponsors (3)

Lead Sponsor	Collaborator
The University of The West Indies	Barbados Diabetes Foundation, Chronic Disease Research Centre

Country where clinical trial is conducted

Barbados, 

References & Publications (2)

Hambleton IR, Jonnalagadda R, Davis CR, Fraser HS, Chaturvedi N, Hennis AJ. All-cause mortality after diabetes-related amputation in Barbados: a prospective case-control study. Diabetes Care. 2009 Feb;32(2):306-7. doi: 10.2337/dc08-1504. Epub 2008 Nov 4. — View Citation

Hennis AJ, Fraser HS, Jonnalagadda R, Fuller J, Chaturvedi N. Explanations for the high risk of diabetes-related amputation in a Caribbean population of black african descent and potential for prevention. Diabetes Care. 2004 Nov;27(11):2636-41. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic Phenotyping (Haptoglobin and TRAPS)		18 months	No
Secondary	Reactive Hyperemia Index and Augmentation Index		18 months	No
Secondary	Depression		18 months	No
Secondary	Quality of Life		18 months	No