- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01002521
Wound Healing In Diabetes (WHy) Study (WHy)
Molecular and Genetic Analysis of Disturbed Wound Healing in Barbadians With Diabetic Foot Ulcers
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Andre R Greenidge, BSc
- Phone Number: 246) 426-6416
- Email: andre.greenidge@cavehill.uwi.edu
Study Contact Backup
- Name: Robert C Landis, PhD
- Phone Number: 246) 426-6416
- Email: clive.landis@cavehill.uwi.edu
Study Locations
-
-
St Michael
-
Bridgetown, St Michael, Barbados, BB11115
- Chronic Disease Research Centre
-
Contact:
- Andre R Greenidge, BSc
- Phone Number: 246) 426-6416
- Email: andre.greenidge@cavehill.uwi.edu
-
Contact:
- R C Landis, PhD
- Phone Number: (246) 426-6416
- Email: clive.landis@cavehill.uwi.edu
-
Principal Investigator:
- Robert C Landis, PhD
-
Sub-Investigator:
- Andre R Greenidge, BSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Cases
Persons With Diabetes (PWD) who have current non-healing ulcer(s)
|
Controls
Persons With Diabetes (PWD) with no current ulcers and no history of ulcers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Genetic Phenotyping (Haptoglobin and TRAPS)
Time Frame: 18 months
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Depression
Time Frame: 18 months
|
18 months
|
Quality of Life
Time Frame: 18 months
|
18 months
|
Reactive Hyperemia Index and Augmentation Index
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Robert C Landis, PhD, University of the West Indies
- Study Chair: Anselm J Hennis, PhD, Univesity of the West Indies
- Study Chair: Ian R Hambleton, PhD, University on the West Indies
- Study Director: Andre R Greenidge, BSc, University of the West Indies
Publications and helpful links
General Publications
- 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. doi: 10.2337/diacare.27.11.2636.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDRC-WHy-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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