Wound Healing In Diabetes (WHy) Study

NCT ID: NCT01002521

Last Updated: 2009-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

605 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-06-30

Brief Summary

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This observational study aims to identify risk factors and molecular mechanisms of impaired wound healing, to guide better foot care in the diabetic population.

Detailed Description

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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.

Conditions

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Impaired Wound Healing Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cases

Persons With Diabetes (PWD) who have current non-healing ulcer(s)

No interventions assigned to this group

Controls

Persons With Diabetes (PWD) with no current ulcers and no history of ulcers

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chronic Disease Research Centre

UNKNOWN

Sponsor Role collaborator

Barbados Diabetes Foundation

OTHER

Sponsor Role collaborator

The University of The West Indies

OTHER

Sponsor Role lead

Responsible Party

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Chronic Disease Research Centre

Principal Investigators

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Robert C Landis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of the West Indies

Anselm J Hennis, PhD

Role: STUDY_CHAIR

Univesity of the West Indies

Ian R Hambleton, PhD

Role: STUDY_CHAIR

University on the West Indies

Andre R Greenidge, BSc

Role: STUDY_DIRECTOR

University of the West Indies

Locations

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Chronic Disease Research Centre

Bridgetown, Saint Michael, Barbados

Site Status

Countries

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Barbados

Central Contacts

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Andre R Greenidge, BSc

Role: CONTACT

246) 426-6416

Robert C Landis, PhD

Role: CONTACT

246) 426-6416

Facility Contacts

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R C Landis, PhD

Role: primary

(246) 426-6416

Andre R Greenidge, BSc

Role: backup

246) 426-6416

References

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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.

Reference Type BACKGROUND
PMID: 15504998 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18984775 (View on PubMed)

Other Identifiers

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CDRC-WHy-1

Identifier Type: -

Identifier Source: org_study_id

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