Health Condition 1: L979- Non-pressure chronic ulcer of unspecified part of lower leg Health Condition 2: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: Amniotic Membrane group: Application of Freshly extracted Balanced Salt Solution treated Amniotic membrane which is applied over Wagner grade I-II Diabetic foot ulcers less than 10cm sq
Sponsors
Dr Dharmendra kumar pipal
Eligibility
Inclusion criteria
Inclusion criteria: Age equal or more than 18 years and less than 65 years Diagnosed diabetes mellitus Wagner grade I II diabetic foot ulcer Ulcer size equal or less than 10 cm Adequate perfusion (ABI equal or more than 0.9 or Doppler-confirmed flow) Ability to provide informed consent
Exclusion criteria
Exclusion criteria: Wagner grade III V ulcers Clinical or radiological evidence of osteomyelitis Critical limb ischemia Severe infection requiring urgent surgical intervention HbA1c more than 12% Chronic steroid therapy or immunosuppressive treatment Chronic kidney disease Malignancy in the ulcer bed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the proportion of patients achieving complete wound healing at 12 weeks between intervention and control groups.Timepoint: baseline, 1st week, 3rd week, 6th week, 12th week. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare time to complete wound healingTimepoint: baseline, 1st week, 3rd week, 6th week, 12th week.;To assess percentage reduction in wound area using planimetric methodsTimepoint: baseline, 6th week, 12th week. | — |
Countries
India
Contacts
Public ContactDr Nikhil B
AIIMS GORAKHPUR
Outcome results
None listed