Clinical trial NCT01002521: Wound Healing In Diabetes (WHy) Study
Official title: Molecular and Genetic Analysis of Disturbed Wound Healing in Barbadians With Diabetic Foot Ulcers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Impaired Wound Healing
Diabetes Mellitus
Keywords: Diabetes
vascular
haptoglobin
tumor
necrosis
factor
alpha
traps
impaired
wound
healing
Impaired wound healing in patients with diabetes mellitus
Lead sponsor: The University of The West Indies
Sponsor class: OTHER
Collaborators: name: Chronic Disease Research Centre
name: Barbados Diabetes Foundation
First posted: 2009-10-27
Enrollment: 605
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Black Barbadians who are clinically diagnosed as type II diabetes mellitus patients

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.

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.

Eligibility 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

Primary outcomes:
measure: Genetic Phenotyping (Haptoglobin and TRAPS)
timeFrame: 18 months
Secondary outcomes:
measure: Reactive Hyperemia Index and Augmentation Index
timeFrame: 18 months
measure: Depression
timeFrame: 18 months
measure: Quality of Life
timeFrame: 18 months
Other outcomes:
Locations:
city: Bridgetown
country: Barbados
facility: Chronic Disease Research Centre
state: St Michael
Study officials:
affiliation: University of the West Indies
name: Robert C Landis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Univesity of the West Indies
name: Anselm J Hennis, PhD
role: STUDY_CHAIR
affiliation: University on the West Indies
name: Ian R Hambleton, PhD
role: STUDY_CHAIR
affiliation: University of the West Indies
name: Andre R Greenidge, BSc
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.