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

Phase 2
Conditions
Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue
Registration Number
CTRI/2023/06/053870
Lead Sponsor
IPGME&R and SSKM Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
Amount of exudate and bacterial contaminationTimepoint: Every week for 6 weeks
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