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A clinical trial to study the effectiveness of autologous platelet rich fibrin therapy in chronic non-healing cutaneous ulcers

Randomised controlled trial comparing the efficacy of autologous platelet rich fibrin therapy versus hydrocolloid gel dressing in chronic non-healing cutaneous ulcers, an open label study from Eastern India.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053870
Enrollment
30
Registered
2023-06-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue

Interventions

Intervention1: Autologous platelet rich fibrin therapy: Autologous platelet rich fibrin was prepared using a table centrifuge and blood collection kit having 10ml syringe and 5ml blood collection tube

Sponsors

IPGME&R and SSKM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)All patients with chronic non-healing cutaneous ulcer more than 6 weeks duration attending dermatology OPD of IPGME&R, SSKM HOSPITAL above 18 years of age and willing to participate. 2)Ulcer area 0.5 sq cm â?? 50 sq cm 3) Hemoglobin more than 9 g/dl 4)Platelet count more than 1,00,000 per cubic mm 5)Fasting blood sugar more than 140 mg/dl

Exclusion criteria

Exclusion criteria: 1)Ulcer area more than 50 sq cm 2)Ulcer exposed with bone, muscle, ligament or tendon 3)Pregnant and lactating woman 4)Ulcers with active discharge or infection 5)Patients with uncontrolled systemic disease 6)Patients on anti-coagulant and immunosuppressive therapy 7)Patients with inherited or acquired immunodeficiency 8)Patients with history of allergy to hydrocolloid gel dressing, colloidal silver and clot accelerator

Design outcomes

Primary

MeasureTime frame
Area of the ulcer will be measured at baseline and the decrease in area compared to the baseline value.Timepoint: Every week for 6 weeks

Secondary

MeasureTime frame
Amount of exudate and bacterial contaminationTimepoint: Every week for 6 weeks

Countries

India

Contacts

Public ContactSaubhagya Chowdhury

IPGME&R and SSKM Hospital

drbnnaskar@gmail.com

Outcome results

None listed

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