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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01351701
Recruitment Status : Unknown
Verified April 2011 by Sun Valley Hospital, Guwahati.
Recruitment status was:  Not yet recruiting
First Posted : May 11, 2011
Last Update Posted : May 11, 2011
Information provided by:
Sun Valley Hospital, Guwahati

Brief 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.

Condition or disease
Diabetic Foot

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : June 2011

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Epidemiological pattern of diabetic foot infection in eastern India [ Time Frame: One year ]
  2. Sensitivity of isolated organisms to antibiotics [ Time Frame: one year ]
  3. Risk factors associated with different grades of severity of DFI [ Time Frame: one year ]

Secondary Outcome Measures :
  1. 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 ]
  2. Common empiric antibiotic therapies used in management of DFI [ Time Frame: one year ]
  3. Percentage sensitivity to different empiric antibiotics [ Time Frame: one year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mixed-Rural/Urban in three eastern states of India

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01351701

Contact: DR SUDHIR Kr Jain, MS (Surgery) 09864062104

Sun Valley Diabetic Care And Research Centre
Guwahati, Assam, India, 781006
Sponsors and Collaborators
Sun Valley Hospital, Guwahati
Principal Investigator: DR SUDHIR Kr JAIN, MS (Surgery) Sun Valley Diabetic Care and Research Centre

Responsible Party: DR SUDHIR KR JAIN 09864062104, Dr Sudhir jain, Sun valley Hospital, Guwahati Identifier: NCT01351701     History of Changes
Other Study ID Numbers: Sunvalley Diabetic Foot Study
First Posted: May 11, 2011    Key Record Dates
Last Update Posted: May 11, 2011
Last Verified: April 2011

Keywords provided by Sun Valley Hospital, Guwahati:
Diabetic foot
Bacteriological epidemiology
Wagner's Grading
eastern India

Additional relevant MeSH terms:
Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Anti-Bacterial Agents
Anti-Infective Agents