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