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Study to compare the effect of using Platelet-rich Fibrin versus Normal saline non-healing wounds of patients with spinal cord injury

Autologous Platelet-Rich Fibrin versus conventional dressing in chronic non-healing ulcers in patients with spinal cord injury and its impact on functional recovery: A Randomised controlled trial - Nil

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/083845
Enrollment
18
Registered
2025-04-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: G959- Disease of spinal cord, unspecified

Interventions

Intervention1: Group A: PRF application over pressure injuries: Baseline assessment and initial management of Pressure Injury (PI) will be done including administration of appropriate antibiotics, deb

Sponsors

All India Institute of Medical Sciences, Raebareli, Uttar Pradesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient having spinal cord injury with chronic non healing ulcer. Age of patient between 18 years to 75 years. Presence of Pressure Injury of grade 2 to 4 (NPIAP) at any location on the patient s body. Patient should be haemodynamically stable and presence of no fever. Platelet count more than 1.5 lakh per ml blood. Haemoglobin more than 11g/dl. Patient must give consent to take part in study.

Exclusion criteria

Exclusion criteria: Presence of severe Anaemia, Thrombocytopenia, Coagulation disorders, Cardiac disorders, history of Malignancy. Presence of Febrile Illness. Pt on immunosuppressants or anticoagulants. Positive Viral Markers. - Under treatment for any Psychiatric issues (failure to comply and follow up). - Pt not willing to participate

Design outcomes

Primary

MeasureTime frame
-Change in Pressure ulcer scale for healing (PUSH) score -Complete healing time period for both groups. -Reduction of surface area -Reduction of volume of the wound. Timepoint: The outcome variables will be assessed every week for the first six weeks, followed by once a month for the next 6 months.

Secondary

MeasureTime frame
-Functional Independence measure (FIM) score -Modified Caregiver Strain Index Timepoint: The outcome variables will be assessed every week for the first six weeks, followed by once a month for the next 6 months.

Countries

India

Contacts

Public ContactDr Arvind Kumar Sharma

All India Institute of Medical Sciences, Raebareli

arvindkgmu25@gmail.com6388930133

Outcome results

None listed

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