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Wound Healing In Diabetes (WHy) Study (WHy)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01002521
Recruitment Status : Unknown
Verified October 2009 by The University of The West Indies.
Recruitment status was:  Not yet recruiting
First Posted : October 27, 2009
Last Update Posted : October 27, 2009
Sponsor:
Collaborators:
Chronic Disease Research Centre
Barbados Diabetes Foundation
Information provided by:
The University of The West Indies

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.

Condition or disease
Impaired Wound Healing Diabetes Mellitus

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.

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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 Barbadians With Diabetic Foot Ulcers
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


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



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


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.


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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

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

Locations
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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
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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:
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Responsible Party: R.Clive Landis/Principal Investigator, Chronic Disease Research Centre
ClinicalTrials.gov Identifier: NCT01002521    
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
vascular
haptoglobin
tumor
necrosis
factor
alpha
traps
impaired
wound
healing
Impaired wound healing in patients with diabetes mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Wounds and Injuries
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases