- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01351701
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 Contact
- Name: DR SUDHIR Kr Jain, MS (Surgery)
- Phone Number: 09864062104
- Email: drsudhirguw@gmail.com
Study Locations
-
-
Assam
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Guwahati, Assam, India, 781006
- Sun Valley Diabetic Care And Research Centre
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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
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
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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