Healing of chronic diabetic foot ulcers.
Not Applicable
- Conditions
- Health Condition 1: L975- Non-pressure chronic ulcer of other part of foot
- Registration Number
- CTRI/2022/02/039944
- Lead Sponsor
- AIIMS Bhubaneswar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Patients >18 years with chronic diabetic foot ulcers and of more than one-month duration.
2.Patients with controlled blood sugars.
3.Ulcers less than 20 cm2 size
Exclusion Criteria
1. Ulcers with suspected/proven malignancy.
2. Patients with peripheral vascular disease.
3. Patients with hypersensitivity to collagen, mupirocin, and metronidazole
4. Psychiatric diseases /un-cooperative patients.
5. Clinically moribund patients.
6. Anticipated transfer to acute care/ operative intervention like amputations, extensive debridements, drainage procedures within 12 weeks.
7. Spreading ulcers
8. Infected/ unhealthy ulcers
9. Ulcers with bone exposed
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of ulcer healing within 12 weeks of randomization.Timepoint: 12 months
- Secondary Outcome Measures
Name Time Method <br/ ><br>Duration of ulcer healing. <br/ ><br>Timepoint: at baseline, 4 weeks and 8 week; <br/ ><br>Time to wound sterility. <br/ ><br>Timepoint: at baseline, 4 weeks and 8 week;Cost of therapy <br/ ><br>Timepoint: at baseline, 4 weeks and 8 week;Number of minor amputations prevented <br/ ><br> <br/ ><br>Timepoint: at baseline, 4 weeks and 8 week;Rate of healing compared to the age of ulcer.Timepoint: at baseline, 4 weeks and 8 week;The number of debridements required after inclusion in the study.Timepoint: at baseline, 4 weeks and 8 week