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 Design
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Study Type : Observational

Estimated Enrollment : 605 participants

Observational Model: Case Control

Time Perspective: Cross-Sectional

Official Title: Molecular and Genetic Analysis of Disturbed Wound Healing in Ba

Study Start Date : December 2009

Estimated Primary Completion Date : June 2011

Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Wounds and Injuries

U.S. FDA Resources

Groups and Cohorts
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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

Outcome Measures
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Primary Outcome Measures :

1. Genetic Phenotyping (Haptoglobin and TRAPS) [ Time Frame: 18 months ]

Secondary Outcome Measures :

1. Reactive Hyperemia Index and Augmentation Index [ Time Frame: 18 months ]
2. Depression [ Time Frame: 18 months ]
3. Quality of Life [ Time Frame: 18 months ]

Biospecimen Retention: Samples With DNA

Whole blood,Serum,DNA,Urine

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor
and family members or friends about deciding to join a study. To learn more about this
study, you or your doctor may contact the study research staff using the contacts provided
below. For general information, Learn About Clinical Studies.

Ages Eligible for Study: Child, Adult, Older Adult

Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
Study Population
Black Barbadians who are clinically diagnosed as type II diabetes mellitus patients
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff
using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002521

Contacts
Contact: Andre R Greenidge, 246) 426- andre.greenidge@cavehill.uwi.ed
BSc 6416 u
Contact: Robert C Landis, PhD 246) 426- clive.landis@cavehill.uwi.edu
6416

Locations

Barbados
Chronic Disease Research Centre
Bridgetown, St Michael, Barbados, BB11115
Contact: R C Landis, PhD (246) 426-6416 clive.landis@cavehill.uwi.edu
Contact: Andre R Greenidge, BSc 246) 426-
6416 andre.greenidge@cavehill.uwi.edu
Principal Investigator: Robert C Landis, PhD
Sub-Investigator: Andre R Greenidge, BSc
Sponsors and Collaborators
The University of The West Indies
Chronic Disease Research Centre
Barbados Diabetes Foundation
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
 More Information
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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.
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.

Responsible Party: R.Clive Landis/Principal Investigator, Chronic Disease Research C

ClinicalTrials.gov Identifier: NCT01002521 History of Changes
Other Study ID Numbers: CDRC-WHy-1
First Posted: October 27, 2009 Key Record Dates
Last Update Posted: October 27, 2009
Last Verified: October 2009
Keywords provided by The University of The West Indies:
Diabetes alpha
vascular traps
haptoglobin impaired
tumor wound
necrosis healing
factor Impaired wound healing in patients with diabetes mellitus
Additional relevant MeSH terms:
Diabetes Mellitus
Wounds and Injuries
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases