Health Condition 1: null- LEPROSY WITH TROPHIC ULCERS
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time 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
JIPMER