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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Sun Valley Hospital, Guwahati.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sun Valley Hospital, Guwahati
ClinicalTrials.gov Identifier:
NCT01351701
First received: April 29, 2011
Last updated: May 10, 2011
Last verified: April 2011
  Purpose

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
Diabetic Foot

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sun Valley Hospital, Guwahati:

Primary Outcome Measures:
  • Epidemiological pattern of diabetic foot infection in eastern India [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Sensitivity of isolated organisms to antibiotics [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Risk factors associated with different grades of severity of DFI [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Common empiric antibiotic therapies used in management of DFI [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Percentage sensitivity to different empiric antibiotics [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2011
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Mixed-Rural/Urban in three eastern states of India

Criteria

Inclusion Criteria:

  • diabetic foot patients with Wagner's grade 2 or more foot infection.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351701

Contacts
Contact: DR SUDHIR Kr Jain, MS (Surgery) 09864062104 drsudhirguw@gmail.com

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

No publications provided

Responsible Party: DR SUDHIR KR JAIN drsudhirguw@gmail.com 09864062104, Dr Sudhir jain, Sun valley Hospital, Guwahati
ClinicalTrials.gov Identifier: NCT01351701     History of Changes
Other Study ID Numbers: Sunvalley Diabetic Foot Study
Study First Received: April 29, 2011
Last Updated: May 10, 2011
Health Authority: India: Institutional Review Board

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

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 21, 2014