CTRI/2012/12/003178Recruiting未知
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.
JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH0 sites66 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Enrollment
- 66
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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
Investigators
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