Wound Healing In Diabetes (WHy) Study | NCT01002521

Studies
Wound Healing In Diabetes (WHy) Study

NCT01002521

Sponsor

The University of The West Indies

Status

Unknown status

Last Update Posted

Oct 27, 2009Estimated

Enrollment

605Estimated

Phase

Not provided

Conditions

Impaired Wound Healing
Diabetes Mellitus

Interventions

Not provided

Countries

Barbados

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Jun 2011Estimated

Completion Date

Jun 2012Estimated

First Submitted Date

Oct 23, 2009

First Submission Date that Met QC Criteria

Oct 26, 2009

First Posted Date

Oct 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2009

Last Update Posted Date

Oct 27, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

The University of The West IndiesOTHER

Collaborators

Name	Class
Chronic Disease Research Centre	UNKNOWN
Barbados Diabetes Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

605Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Genetic Phenotyping (Haptoglobin and TRAPS)		18 months

Secondary Outcomes

Measure	Description	Time Frame
Reactive Hyperemia Index and Augmentation Index		18 months
Depression		18 months
Quality of Life

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

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

Overall Officials

Name	Affiliation	Role
Robert C Landis, PhD	University of the West Indies	Principal Investigator
Anselm J Hennis, PhD	Univesity of the West Indies	Study Chair
Ian R Hambleton, PhD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chronic Disease Research Centre		Bridgetown	Saint Michael	BB11115	Barbados

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15504998	Background	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.
18984775	Background	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.

ID	Term
D003920	Diabetes Mellitus
D009369	Neoplasms
D009336	Necrosis
C536657	Periodic fever, familial, autosomal dominant
D014947	Wounds and Injuries

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases