Comparative analysis of four systems of classification of diabetic foot ulcers in predicting lower extremity amputation (LEA) rate
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 108
- Locations
- 1
Study Overview
Brief Summary
Patients with diabetic foot ulcer who meet the eligibility criteria presenting to the Kasturba Hospital Surgery OPD or admitted as in-patients will be recruited into the study. Detailed clinical examination will be performed and data will be collected using a proforma, including patient demographic details, history of diabetes, ulcer history and clinical examination findings. Baseline characteristics of the ulcer will be recorded. On the basis of the clinical examination, the ulcer will be staged under the four classifications intended to be compared. The patient will be followed up after one month telephonically to assess the outcome of each case, primarily in the form of lower extremity amputation and secondarily as need for debridement, development of sepsis and need for ICU stay.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 85.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adult patients diagnosed with Type 1 or Type 2 Diabetes Mellitus with diabetic foot ulcer, visiting the Surgery OPD or admitted in wards
- •All diabetic foot ulcers irrespective of duration and presence of infection, peripheral vascular disease, diabetic neuropathy
- •Ability to consent and participate in the study.
Exclusion Criteria
- •Diabetic individuals with ulcers above ankle
- •Patients with prior major lower extremity amputation, those with pre-existing below knee or above knee amputations
- •Participants who are lost to follow up or whose outcomes are unknown
- •Patients with cognitive impairments who cannot provide informed consent.
Investigators
Dr Poojary Yasha Babu
Kasturba Medical College, Manipal