Wound Healing In Diabetes (WHy) Study (WHy)

October 26, 2009 updated by: The University of The West Indies

Molecular and Genetic Analysis of Disturbed Wound Healing in Barbadians With Diabetic Foot Ulcers

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

Study Overview

Status

Unknown

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

Observational

Enrollment (Anticipated)

605

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Barbados
    • St Michael
      • Bridgetown, St Michael, Barbados, BB11115
        • Chronic Disease Research Centre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robert C Landis, PhD
        • Sub-Investigator:
          • Andre R Greenidge, BSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Black Barbadians who are clinically diagnosed as type II diabetes mellitus patients

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

The University of The West Indies

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

October 23, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (Estimate)

October 27, 2009

Study Record Updates

Last Update Posted (Estimate)

October 27, 2009

Last Update Submitted That Met QC Criteria

October 26, 2009

Last Verified

October 1, 2009

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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