Bacteriological Study of Diabetic Foot and Antibiotic Sensitivity Pattern in Eastern India

May 10, 2011 updated by: Sun Valley Hospital, Guwahati

An Observational, Prospective, Multicentre Study in Eastern India to Understand the Bacteriological Epidemiology in Diabetic Foot and Sensitivity Pattern of Antibiotics Along With the Pattern of Empirical Therapy

The pattern of organism causing diabetic foot infection are presumed to vary from location to location depending on the antibiotic prescription practice, geographical locations, environmental variations and therapeutic interventions for various patients. Our hypothesis is look to finding out common similarities with diversified subgroups spread across various geographical locations of eastern part of India, thus to create a data base for treating patient with diabetic foot infections.The sensitivity pattern is anticipated to be different from institution to institutions and place to place but the gross sensitivity data of local pathogen could guide physician for choosing right empirical antibiotic. Practice guideline could be postulated from the collated data of distribution of pathogens, their sensitivity pattern as well as co-morbid conditions of the sufferers.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

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

  • India
    • Assam
      • Guwahati, Assam, India, 781006
        • Sun Valley Diabetic Care And Research Centre

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Mixed-Rural/Urban in three eastern states of India

Description

Inclusion Criteria:

  • diabetic foot patients with Wagner's grade 2 or more foot infection.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Epidemiological pattern of diabetic foot infection in eastern India
Time Frame: One year
One year
Sensitivity of isolated organisms to antibiotics
Time Frame: one year
one year
Risk factors associated with different grades of severity of DFI
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
To record prevailing management practices of diabetic foot infection in terms of disease, antibiotic practice, practice of supportive and surgical care.
Time Frame: one year
one year
Common empiric antibiotic therapies used in management of DFI
Time Frame: one year
one year
Percentage sensitivity to different empiric antibiotics
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

Sun Valley Hospital, Guwahati

Investigators

  • Principal Investigator: DR SUDHIR Kr JAIN, MS (Surgery), Sun Valley Diabetic Care And Research Centre

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, 2011

Study Registration Dates

First Submitted

April 29, 2011

First Submitted That Met QC Criteria

May 10, 2011

First Posted (Estimate)

May 11, 2011

Study Record Updates

Last Update Posted (Estimate)

May 11, 2011

Last Update Submitted That Met QC Criteria

May 10, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sunvalley Diabetic Foot Study

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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