Efficacy of autologous platelet-rich fibrin (PRF) over moist sterile saline dressing in chronic trophic ulcers in Hansenâ??s disease patients â?? a Randomised Control Trial.

Not Applicable

• Conditions: Health Condition 1: null- LEPROSY WITH TROPHIC ULCERS

• Registration Number: CTRI/2012/12/003178
• Lead Sponsor: JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 66

Inclusion Criteria

Patients with Hansenâ??s disease who have chronic trophic ulcers of lower extremity of > 6 months duration, attending the dermatology out-patient department in JIPMER, having an ulcer area of 1cm x 1cm to 5cm x 5 cm, and belonging to stage II or stage III of the European Pressure Ulcer Advisory Panel (EPUAP) scheme

Exclusion Criteria

Ulcers < 6 months duration.

Ulcers of other etiology e.g. venous ulcer/arterial ulcer/diabetic ulcer/ulcer with underlying vasculitis.

Patients with osteomyelitis affecting the area of the ulcer.

Ulcers with exposure of tendons or bones.

Ulcers with area <1cm x 1cm or > 5cm x 5cm

Ulcers with copious discharge /overt infection /infected with Pseudomonas.

Patients with HIV/ HBsAg/ HCV

Hemoglobin < 11 gm/dl and/or platelet count < 1,50,000/ mm3

Serum albumin < 4.5 mg/dl

Patients with malignancy/ uncontrolled diabetes mellitus/received radiation therapy/on drugs like steroids, immunosuppressive agents/compromised cardiopulmonary status/ compromised endocrine status/ acid-base imbalance/ renal failure/ liver failure/ any other factor impairing wound healing.

Patients receiving anti-coagulants/ anti-platelet drugs/ bleeding diathesis

Patients with age < 18 years or > 65 years

Pregnancy and lactation

Non-consenting patients

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of autologous PRF with moist saline dressing in patients with chronic trophic ulcers in leprosy. <br/ ><br>To assess the antibacterial effect of PRF in vitro. <br/ ><br>Timepoint: Baseline <br/ ><br>week 1 <br/ ><br>week 2 <br/ ><br>week 3 <br/ ><br>week 4 <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
To compare the mean reduction in ulcer area and volume at end of 4 weeks. <br/ ><br>To compare the percentage of patients who achieved complete healing of ulcer. <br/ ><br>To compare the time required to achieve complete healing. <br/ ><br>To determine the antibacterial effect of PRF in vitro. <br/ ><br>To assess the bacterial colonization of wounds after complete 4 weeks of PRF treatment. <br/ ><br>Timepoint: baseline <br/ ><br>week1 <br/ ><br>week2 <br/ ><br>week3 <br/ ><br>week4