NCT01351701

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 11, 2011

Completed
21 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
Last Updated

May 11, 2011

Status Verified

April 1, 2011

First QC Date

April 29, 2011

Last Update Submit

May 10, 2011

Conditions

Keywords

Diabetic footBacteriological epidemiologyWagner's Gradingeastern India

Outcome Measures

Primary Outcomes (3)

  • Epidemiological pattern of diabetic foot infection in eastern India

    One year

  • Sensitivity of isolated organisms to antibiotics

    one year

  • Risk factors associated with different grades of severity of DFI

    one year

Secondary Outcomes (3)

  • To record prevailing management practices of diabetic foot infection in terms of disease, antibiotic practice, practice of supportive and surgical care.

    one year

  • Common empiric antibiotic therapies used in management of DFI

    one year

  • Percentage sensitivity to different empiric antibiotics

    one year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mixed-Rural/Urban in three eastern states of India

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Valley Diabetic Care And Research Centre

Guwahati, Assam, 781006, India

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • DR SUDHIR Kr JAIN, MS (Surgery)

    Sun Valley Diabetic Care and Research Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

DR SUDHIR Kr Jain, MS (Surgery)

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 29, 2011

First Posted

May 11, 2011

Study Start

June 1, 2011

Last Updated

May 11, 2011

Record last verified: 2011-04

Locations