Wound Healing In Diabetes (WHy) Study
WHy
Molecular and Genetic Analysis of Disturbed Wound Healing in Barbadians With Diabetic Foot Ulcers
1 other identifier
observational
605
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2009
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2009
CompletedFirst Posted
Study publicly available on registry
October 27, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedOctober 27, 2009
October 1, 2009
1.5 years
October 23, 2009
October 26, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Genetic Phenotyping (Haptoglobin and TRAPS)
18 months
Secondary Outcomes (3)
Reactive Hyperemia Index and Augmentation Index
18 months
Depression
18 months
Quality of Life
18 months
Study Arms (2)
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
Eligibility Criteria
Black Barbadians who are clinically diagnosed as type II diabetes mellitus patients
You may qualify if:
- clinical diagnosis of diabetes
- Barbadian national
- self reported ethnicity of Black/African descent
- clear knowledge of ulcer history
You may not qualify if:
- no clinical diagnosis of diabetes
- non-national of Barbados
- self reported ethnicity not Black/African Descent
- unclear knowledge of ulcer history
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of The West Indieslead
- Chronic Disease Research Centrecollaborator
- Barbados Diabetes Foundationcollaborator
Study Sites (1)
Chronic Disease Research Centre
Bridgetown, Saint Michael, BB11115, Barbados
Related Publications (2)
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.
PMID: 15504998BACKGROUNDHambleton 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.
PMID: 18984775BACKGROUND
Biospecimen
Whole blood,Serum,DNA,Urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 23, 2009
First Posted
October 27, 2009
Study Start
December 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2012
Last Updated
October 27, 2009
Record last verified: 2009-10