A Novel Method to Deliver Antibiotics directly to the Open Wounds in diabetic Patients
- Conditions
- Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
- Registration Number
- CTRI/2019/08/020819
- Lead Sponsor
- Apollo Hospitals Educational and Research Foundation AHERF
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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 < 0.8
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Time to complete ulcer healing <br/ ><br>2.Estimation Proportion of people with an ulcer that completely healed <br/ ><br> <br/ ><br>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 Outcome Measures
Name Time Method 1.Time to complete ulcer healing <br/ ><br>2.Estimation Proportion of people with an ulcer <br/ ><br>that completely healed <br/ ><br> <br/ ><br>3.Resolution of infection <br/ ><br>4.Reduction risk of surgical resection of foot wound including partial or complete lower limb amputation <br/ ><br>5.Patientâ??s Fitness and quality of Life <br/ ><br>Improving Immunological status patients <br/ ><br>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.