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NCT01351701 Clinical Trial

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

Diabetic Foot Clinical Trial

Official title:
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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01351701
Other study ID # Sunvalley Diabetic Foot Study
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 29, 2011
Last updated May 10, 2011
Start date June 2011

Study information
Verified date April 2011
Source Sun Valley Hospital, Guwahati
Contact DR SUDHIR Kr Jain, MS (Surgery)
Phone 09864062104
Email drsudhirguw@gmail.com
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
India Sun Valley Diabetic Care And Research Centre Guwahati Assam

Sponsors (1)
Lead Sponsor Collaborator
Sun Valley Hospital, Guwahati

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Epidemiological pattern of diabetic foot infection in eastern India One year No
Primary Sensitivity of isolated organisms to antibiotics one year No
Primary Risk factors associated with different grades of severity of DFI one year No
Secondary To record prevailing management practices of diabetic foot infection in terms of disease, antibiotic practice, practice of supportive and surgical care. one year No
Secondary Common empiric antibiotic therapies used in management of DFI one year No
Secondary Percentage sensitivity to different empiric antibiotics one year No
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