Diabetic FootNCT01351701
Bacteriological Study of Diabetic Foot and Antibiotic Sensitivity Pattern in Eastern India
An observational study of Diabetic Foot, run by Sun Valley Hospital, Guwahati at 1 site in India.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Foot
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2011to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Mixed-Rural/Urban in three eastern states of India
Who may be able to join
- diabetic foot patients with Wagner's grade 2 or more foot infection.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
India1 site
Sun Valley Diabetic Care And Research Centre
Guwahati, Assam, 781006
About this study
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
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.
- Conditions
- Diabetic Foot
- Keywords
- Diabetic foot, Bacteriological epidemiology, Wagner's Grading, eastern India
- Medical subject headings
- Diabetic Foot
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiological pattern of diabetic foot infection in eastern India
Measured: One year
Sensitivity of isolated organisms to antibiotics
Measured: one year
Risk factors associated with different grades of severity of DFI
Measured: 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.
Measured: one year
Common empiric antibiotic therapies used in management of DFI
Measured: one year
Percentage sensitivity to different empiric antibiotics
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Valley Hospital, Guwahati
- Sponsor type
- University, hospital or other
- Investigators
- DR SUDHIR Kr JAIN, MS (Surgery), Principal investigator, Sun Valley Diabetic Care and Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351701
- Sponsor's protocol ID
- Sunvalley Diabetic Foot Study
- Status last verified
- Apr 2011
- First submitted
- 29 Apr 2011
- Last updated
- 11 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01351701
- Acronym / sponsor ID
- Sunvalley Diabetic Foot Study
- Conditions
- Diabetic Foot
- Keywords
- Diabetic foot, Bacteriological epidemiology, Wagner's Grading, eastern India
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sun Valley Hospital, GuwahatiUniversity, hospital or other
- Study start
- Jun 2011
- First posted
- 11 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mixed-Rural/Urban in three eastern states of India
Key inclusion criteria (1 listed)
- diabetic foot patients with Wagner's grade 2 or more foot infection.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epidemiological pattern of diabetic foot infection in eastern India
Time frame: One year
Sensitivity of isolated organisms to antibiotics
Time frame: one year
Risk factors associated with different grades of severity of DFI
Time frame: one year
3 secondary outcomes
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
Common empiric antibiotic therapies used in management of DFI
Time frame: one year
Percentage sensitivity to different empiric antibiotics
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DR SUDHIR Kr JAIN, MS (Surgery) principal investigator
Sun Valley Diabetic Care and Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot, run by Sun Valley Hospital, Guwahati at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DR SUDHIR Kr Jain, MS (Surgery) (09864062104, drsudhirguw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiological pattern of diabetic foot infection in eastern India (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2011.