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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01002521
Date of registration: 23/10/2009
Prospective Registration: Yes
Primary sponsor: The University of The West Indies
Public title: Wound Healing In Diabetes (WHy) Study WHy
Scientific title: Molecular and Genetic Analysis of Disturbed Wound Healing in Barbadians With Diabetic Foot Ulcers
Date of first enrolment: December 2009
Target sample size: 605
Recruitment status: Not yet recruiting
URL:  http://clinicaltrials.gov/show/NCT01002521
Study type:  Observational
Study design:  Observational Model: Case Control, Time Perspective: Cross-Sectional  
Phase:  N/A
Countries of recruitment
Barbados
Contacts
Name:     Andre R Greenidge, BSc
Address: 
Telephone:
Email:
Affiliation:  University of the West Indies
Name:     Anselm J Hennis, PhD
Address: 
Telephone:
Email:
Affiliation:  Univesity of the West Indies
Name:     Ian R Hambleton, PhD
Address: 
Telephone:
Email:
Affiliation:  University on the West Indies
Name:     Robert C Landis, PhD
Address: 
Telephone:
Email:
Affiliation:  University of the West Indies
Name:     Andre R Greenidge, BSc
Address: 
Telephone: 246) 426-6416
Email: andre.greenidge@cavehill.uwi.edu
Affiliation: 
Name:     R C Landis, PhD
Address: 
Telephone: (246) 426-6416
Email: clive.landis@cavehill.uwi.edu
Affiliation: 
Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Diabetes Mellitus
Impaired Wound Healing
Intervention(s)
Primary Outcome(s)
Genetic Phenotyping (Haptoglobin and TRAPS) [Time Frame: 18 months]
Secondary Outcome(s)
Reactive Hyperemia Index and Augmentation Index [Time Frame: 18 months]
Depression [Time Frame: 18 months]
Quality of Life [Time Frame: 18 months]
Secondary ID(s)
CDRC-WHy-1
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Barbados Diabetes Foundation
Chronic Disease Research Centre
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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