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Clinical Trials/CTRI/2023/09/058013
CTRI/2023/09/058013Not yet recruitingNot Applicable

Prospective observational study to assess risk factors leading to Amputation in Diabetic foot patients at a tertiary health care center in Belagavi

Dr Praveen Krishnan1 site in 1 country60 target enrollmentStarted: March 10, 2023Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
To determine risk factors leading to amputation in diabetic foot patients.

Study Overview

Brief Summary

Diabetes is  the  most common  underlying  cause of  foot ulcers,  infection  and  ischemia,  which are  among  the most serious  complications  of diabetes,  leading  to hospitalization  and the  most  frequent cause  of  non- traumatic  lower extremity  amputation. Despite well-defined risk factors for diabeticfoot ulcer development, limited data are available as to which factors predictamputation in a diabetic foot ulcer episode. There are numerous classification systems fordiabetic foot ulcer outcome prediction, but only few studies evaluated theirreliability and validity. Thus, asingle or simplified classification system, which includes the most accuratepredictive factors for amputation, would facilitate decision-making. Therefore, topredict lower limb  amputation  occurrence and  to determine  the  factors associated  with  the risk  of amputation in diabetic footpatients, we conducted this study.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Diabetic patients with written and informed consent, of either sex with foot infections defined as infection of soft tissue in diagnosed case of diabetes mellitus with or without treatment and newly- diagnosed diabetics.

Exclusion Criteria

  • Patients with history of previous amputations -Those suffering from HIV,HBSAg,HCV positivity, psychiatry disorders -Pregnant and lactating females -Patients receiving immunosuppressive therapy and radiotherapy.

Outcomes

Primary Outcomes

To determine risk factors leading to amputation in diabetic foot patients.

Time Frame: 1 Year

Secondary Outcomes

  • To predict lower limb amputation occurrence(1 Year)

Investigators

Sponsor
Dr Praveen Krishnan
Sponsor Class
Other [self-funded]

Study Sites (1)

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