Effectiveness and safety of topical platelet-rich-fibrin-membrane with plaster-cast versus injectable platelet-rich-plasma therapy with plaster-cast in trophic ulcer due to leprosy: randomised-controlled-trial

Effectiveness and safety of topical autologous platelet-rich-fibrin-membrane with total-contact-cast versus perilesional injectable autologous platelet-rich-plasma therapy with total-contact-cast in trophic ulcer due to leprosy: randomised-controlled-trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/09/036230

Enrollment

Registered

2021-09-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L896- Pressure ulcer of heel

Interventions

Intervention1: Autologous platelet-rich-fibrin-membrane therapy: Platelet-rich-fibrin-membrane will be prepared as per the guidelines by Jagati A, Chaudhary RG, Rathod SP, Madke B, Baxi KD, Kasundra D

12:174-8.[ref] with some modifications to make it more economically viable and practically applicable for the resource-poor setting dealing with leprosy care. Approximately 8 mL of venous blood will b

Eligibility

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The primary effectiveness parameter is the percentage reduction in ulcer surface area. Ulcer surface area was calculated with the help of tracing paper and cm2 graph paper at each visit.Timepoint: 10 weeks	—

Secondary

Measure	Time frame
Changes in laboratory values of routine hemogram, fasting blood glucose, serum urea, creatinine and liver function tests will be recorded.Timepoint: At baseline(0 week) and third follow-up(6th week).;Vital signs, spontaneously reported adverse events and those elicited by the clinician will be assessed.Timepoint: Every 2 weeks till last follow-up.;Quality of life in patients with trophic ulcer due to leprosy will be assessed by a validated vernacular (Bengali) version of Dermatology Life Quality Index (DLQI), which consists of 10 questions, each scored between 0 and 3.Timepoint: At baseline(0 week), third follow-up(6th week) and fifth follow-up(10th week).	—

Measure

Time frame

Changes in laboratory values of routine hemogram, fasting blood glucose, serum urea, creatinine and liver function tests will be recorded.Timepoint: At baseline(0 week) and third follow-up(6th week).;Vital signs, spontaneously reported adverse events and those elicited by the clinician will be assessed.Timepoint: Every 2 weeks till last follow-up.;Quality of life in patients with trophic ulcer due to leprosy will be assessed by a validated vernacular (Bengali) version of Dermatology Life Quality Index (DLQI), which consists of 10 questions, each scored between 0 and 3.Timepoint: At baseline(0 week), third follow-up(6th week) and fifth follow-up(10th week).

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Countries

India

Contacts

Public ContactDR ANIRBAN MUKHERJEE

BANKURA SAMMILANI MEDICAL COLLEGE AND HOSPITAL

drdasnilay@gmail.com9433394148

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026