Effectiveness and safety of topical platelet-rich-fibrin-membrane with plaster-cast versus injectableplatelet-rich-plasma therapy with plaster-cast in trophic ulcer due to leprosy:randomised-controlled-trial
Phase 4
- Conditions
- Health Condition 1: L896- Pressure ulcer of heel
- Registration Number
- CTRI/2021/09/036230
- Lead Sponsor
- BANKURA SAMMILANI MEDICAL COLLEGE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Age more than 18 years up to 80 years.
2. Leprosy patients who are treatment-naive for leg ulcer of either sex.
3. Clinically diagnosed trophic ulcer due to leprosy located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces); and wound area (length x width) measurement <10 cm2.
Exclusion Criteria
1. Pregnant and lactating women.
2. Patients with clinically diagnosed arterial or venous ulcer on the
leg or foot.
3. Concomitant immune defect, heart disease, renal failure,
malignancy.
4. Patients with psychiatric disorders.
5. Participation in any clinical trial in last 3 months.
6. Non-consenting patients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary effectiveness parameter is the <br/ ><br>percentage reduction in ulcer surface area. Ulcer <br/ ><br>surface area was calculated with the help of <br/ ><br>tracing paper and cm2 graph paper at each visit.Timepoint: 10 weeks
- Secondary Outcome Measures
Name Time Method Changes in laboratory values of routine <br/ ><br>hemogram, fasting blood glucose, serum urea, <br/ ><br>creatinine and liver function tests will be <br/ ><br>recorded.Timepoint: At baseline(0 week) and third follow-up(6th <br/ ><br>week).;Vital signs, spontaneously reported adverse <br/ ><br>events and those elicited by the clinician will be <br/ ><br>assessed.Timepoint: Every 2 weeks till last follow-up.;Quality of life in patients with trophic ulcer due to <br/ ><br>leprosy will be assessed by a validated <br/ ><br>vernacular (Bengali) version of Dermatology Life <br/ ><br>Quality Index (DLQI), which consists of 10 <br/ ><br>questions, each scored between 0 and 3.Timepoint: At baseline(0 week), third follow-up(6th week) <br/ ><br>and fifth follow-up(10th week).