Natural History of Pedal Puncture Wounds in Diabetics

January 11, 2011 updated by: Cornwall Regional Hospital

The Natural History of Pedal Puncture Wounds in Diabetics: a Cross-sectional Survey in the Parish of St. James, Jamaica.

There are no evidence (research) based guidelines for treatment of early, closed puncture wounds of the feet in diabetics. Surgeons usually see only the limb- and life-threatening consequences of puncture wounds of the feet in diabetics, and are therefore tempted to advocate more aggressive, preemptive, invasive primary treatment for all such wounds, assuming, from this blinkered perspective that all such wounds progress to serious infection. This study is designed to determine the natural history of puncture wounds of the feet in diabetics, specifically, whether all become infected or whether some do heal without any surgical intervention. It requires administration of a questionnaire to 188 known diabetics attending 11 selected outpatient health care centers in the parish of St. James, Jamaica.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

188

Contacts and Locations

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

Study Locations

  • Jamaica
    • St. James
      • Montego Bay, St. James, Jamaica
        • Cornwall Regional Hospital
      • Montego Bay, St. James, Jamaica
        • Health Centers of the St. James Health Department
      • Montego Bay, St. James, Jamaica
        • Private clinic of Dr. Curtis Yeates
      • Montego Bay, St. James, Jamaica
        • Private clinic of Dr. Hector Robinson

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

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diabetics attending 3 public hospital outpatient clinics, 6 public Health Center primary care clinics and 2 private Internist's clinics.

Description

Inclusion Criteria:

  • Diabetic
  • 15 years and older
  • Resident in the parish of St. James, Jamaica

Exclusion Criteria:

  • Impairment of conscious level or mental status such that autonomy is compromised

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

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Diabetics
Diabetics in the parish of St. James, Jamaica

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pedal puncture wounds
Time Frame: September, 2010
September, 2010

Secondary Outcome Measures

Outcome Measure
Time Frame
Infection in pedal puncture wounds
Time Frame: September, 2010
September, 2010

Collaborators and Investigators

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

Sponsor

Cornwall Regional Hospital

Collaborators

St. James Health Department
Private Practice of Dr. Hector Robinson
Private Practice of Dr. Curtis Yeates

Investigators

  • Principal Investigator: Jeffrey M East, MD, Cornwall Regional Hospital

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

June 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

June 28, 2010

First Submitted That Met QC Criteria

June 28, 2010

First Posted (Estimate)

June 29, 2010

Study Record Updates

Last Update Posted (Estimate)

January 12, 2011

Last Update Submitted That Met QC Criteria

January 11, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JE-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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