Impaired Wound HealingWHyNCT01002521
Wound Healing In Diabetes (WHy) Study
An observational study of Impaired Wound Healing and Diabetes Mellitus, run by The University of The West Indies at 1 site in Barbados.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Impaired Wound Healing, Diabetes Mellitus
- How many people
- 605 participants
- Where
- 1 siteBarbados
- Study dates
- Dec 2009to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Black Barbadians who are clinically diagnosed as type II diabetes mellitus patients
Who may be able to join
- clinical diagnosis of diabetes
- Barbadian national
- self reported ethnicity of Black/African descent
- clear knowledge of ulcer history
Who cannot join
- no clinical diagnosis of diabetes
- non-national of Barbados
- self reported ethnicity not Black/African Descent
- unclear knowledge of ulcer history
Trial locations and contacts
1 site in 1 country.
Barbados1 site
Chronic Disease Research Centre
Bridgetown, Saint Michael, BB11115
R C Landis, PhD, (246) 426-6416, clive.landis@cavehill.uwi.edu
Andre R Greenidge, BSc, 246) 426-6416, andre.greenidge@cavehill.uwi.edu
About this study
Official title: 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.
Read the 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.
- 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
- Medical subject headings
- Diabetes Mellitus, Neoplasms, Necrosis, Periodic fever, familial, autosomal dominant, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Genetic Phenotyping (Haptoglobin and TRAPS)
Measured: 18 months
Secondary outcomes (3)
Reactive Hyperemia Index and Augmentation Index
Measured: 18 months
Depression
Measured: 18 months
Quality of Life
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startDec 2009
- Primary completionJun 2011 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Impaired Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 605 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Collaborators
- Chronic Disease Research Centre, Barbados Diabetes Foundation
- Investigators
- Robert C Landis, PhD, Principal investigator, University of the West IndiesAnselm J Hennis, PhD, Study chair, Univesity of the West IndiesIan R Hambleton, PhD, Study chair, University on the West IndiesAndre R Greenidge, BSc, Study director, University of the West Indies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002521
- Sponsor's protocol ID
- CDRC-WHy-1
- Acronym
- WHy
- Status last verified
- Oct 2009
- First submitted
- 23 Oct 2009
- Last updated
- 27 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15504998Hambleton 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.
PubMed 18984775
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Genetic Analysis of Disturbed Wound Healing in Barbadians With Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT01002521
- Acronym / sponsor ID
- WHy / CDRC-WHy-1
- Conditions
- Impaired Wound Healing, Diabetes Mellitus
- Keywords
- Diabetes, vascular, haptoglobin, tumor, necrosis, factor, alpha, traps
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 605 participants (estimated)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Collaborators
- Chronic Disease Research Centre, Barbados Diabetes Foundation
- Study start
- Dec 2009
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 27 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Black Barbadians who are clinically diagnosed as type II diabetes mellitus patients
Key inclusion criteria (4 listed)
- clinical diagnosis of diabetes
- Barbadian national
- self reported ethnicity of Black/African descent
- clear knowledge of ulcer history
Key exclusion criteria (4 listed)
- no clinical diagnosis of diabetes
- non-national of Barbados
- self reported ethnicity not Black/African Descent
- unclear knowledge of ulcer history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genetic Phenotyping (Haptoglobin and TRAPS)
Time frame: 18 months
3 secondary outcomes
Reactive Hyperemia Index and Augmentation Index
Time frame: 18 months
Depression
Time frame: 18 months
Quality of Life
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2009.
- Background: PubMed 15504998Hennis 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.
- Background: PubMed 18984775Hambleton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert C Landis, PhD principal investigator
University of the West Indies
Anselm J Hennis, PhD study chair
Univesity of the West Indies
Ian R Hambleton, PhD study chair
University on the West Indies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Impaired Wound Healing and Diabetes Mellitus, run by The University of The West Indies at 1 site in Barbados.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Barbados. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andre R Greenidge, BSc (246) 426-6416, andre.greenidge@cavehill.uwi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic Phenotyping (Haptoglobin and TRAPS) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01002521, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2009.