Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: 1.Local Antibiotic Delivery method using Vitamin D3 granules impregnated with antibiotics
2.Debridement or curettage if necessary
: Local Antibiotic Delivery Methods and treatment det
Sponsors
Apollo Hospitals Educational and Research Foundation AHERF
Eligibility
Inclusion criteria
Inclusion criteria: 1.Diabetes with an HB1A1c of less than or equal to 9% 2.No evidence of circulatory compromise 3.Posterior tibial or pedal pulse present on palpation 4.No pallor on elevation No dependent rubor 5Ankle brachial index >0.8 6.Loss of sensation on foot using monofilament 7.Wound or callus on either one or both feet. 8.Wound Classification - Wagner Grade 2 & 3 9.Ulcer present for last 1 - 3 months 10.Ulcer below the malleoli 12. No previous ulcer of that foot or amputation of either extremity 13. Wound size 2cm or more than 2cm diameter
Exclusion criteria
Exclusion criteria: Exclusion criteria 1.Diagnoses with unpredictable trajectory or healing ability, i.e. 2.Psychiatric disorders 3.Cancer 4.ESRD not eligible for dialysis 5.HIV paitient 6.Charcot foot Evidence of circulatory compromise 7.Absence of pulses 8.Decreased capillary refill ( > 3 seconds) 9.Ankle Brachial Index
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Time to complete ulcer healing 2.Estimation Proportion of people with an ulcer that completely healed Timepoint: Patients will be assessed on 4th day and as healing progresses then once a week. At each visit there will be a dressing change, wound assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Time to complete ulcer healing 2.Estimation Proportion of people with an ulcer that completely healed 3.Resolution of infection 4.Reduction risk of surgical resection of foot wound including partial or complete lower limb amputation 5.Patientâ??s Fitness and quality of Life Improving Immunological status patients Timepoint: After the patient have been fully treated of infection and wound has healed, patient will be followed at the Apollo Indraprastha Hospitals Orthopaedic OPD. The wound area will be inspected for signs of infection like erythema, redness, cellulitis, and pus discharge will be observed. patient will be followed at every 3 months and his health status would be ascertained up to 1 year from the date of start of treatment. | — |
Countries
India
Contacts
Public ContactDr Chander Shekhar
Apollo Hospitals Educational and Research Foundation (AHERF)
Outcome results
None listed