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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01002521
Other study ID # CDRC-WHy-1
Secondary ID
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


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
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