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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.

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/12/003178
Enrollment
66
Registered
2012-12-04
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: null- LEPROSY WITH TROPHIC ULCERS

Interventions

Intervention1: platelet rich fibrin: PRF preparation requires a table centrifuge and collection kit comprising of vacutainer and attached needle. Under sterile precautions, 50 ml of whole blood will b

Sponsors

JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Ulcers 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 5cm x 5cm Ulcers with copious discharge /overt infection /infected with Pseudomonas. Patients with HIV/ HBsAg/ HCV Hemoglobin Serum albumin 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 65 years Pregnancy and lactation Non-consenting patients

Design outcomes

Primary

MeasureTime frame
To compare the efficacy of autologous PRF with moist saline dressing in patients with chronic trophic ulcers in leprosy. To assess the antibacterial effect of PRF in vitro. Timepoint: Baseline week 1 week 2 week 3 week 4

Secondary

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

Countries

India

Contacts

Public ContactDIVYA GUPTA

JIPMER

laxmishac@gmail.com

Outcome results

None listed

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