A study to identify effectiveness of Platelet rich fibrin for pressure ulcer healing in spinal cord injury patients.

PROLIFerATE Trial: A Pilot, Double-blind, Prospective, Randomized, Controlled Trial to Study the Efficacy of Autologous PlATElet-Rich Fibrin for Pressure Injury Healing in persons with SpinaL COrd Injury - PROLIFerATE

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/12/048610

Enrollment

Registered

2022-12-30

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

Health Condition 1: T148- Other injury of unspecified body region

Interventions

Intervention1: PLATELET-RICH FIBRIN (PRF): PRF DRESSING WILL BE DONE WEEKLY IN THE CONCERNED ulcer for 4 weeks Control Intervention1: NORMAL SALINE (0.9%): NORMAL SALINE DRESSING WILL BE DONE DAILY IN

Eligibility

Inclusion criteria

Inclusion criteria: Age: 18 years of age or older; Either gender. Grade II, III, IV pressure injury according to the National Pressure Ulcer Advisory Panel (NPUAP) new guidelines 2016; Patients having two or multiples of 2 PIs; Signed informed consent.

Exclusion criteria

Exclusion criteria: Patients having malignant disorder; Osteomyelitis or active infection in concerned pressure injury or systemic infection; or any current active illness (CVS, neurological deteriorations, hematological, etc.) contraindicating any interventions or PRP use; Not willing to participate in the study

Design outcomes

Primary

Measure	Time frame
Changes in Pressure Ulcer Scale for Healing (PUSH) tool 3.0.Timepoint: Changes in Pressure Ulcer Scale for Healing (PUSH) tool 3.0. AT 1, 2, 3, 4 WEEKS	—

Secondary

Measure	Time frame
Change (like percentage decrease) in wound surface area (WSA); Healing rate; Cost estimation; Clinical examination/assessment in terms of formation of granulation tissue, moisture balance, infection and measurements; Changes in SCI PUMT; Changes in pressure ulcer part in Version 1.1 of the international spinal cord injury skin and thermoregulation function basic data set.Timepoint: AT 1, 2, 3, 4 WEEKS	—

Measure

Time frame

Change (like percentage decrease) in wound surface area (WSA); Healing rate; Cost estimation; Clinical examination/assessment in terms of formation of granulation tissue, moisture balance, infection and measurements; Changes in SCI PUMT; Changes in pressure ulcer part in Version 1.1 of the international spinal cord injury skin and thermoregulation function basic data set.Timepoint: AT 1, 2, 3, 4 WEEKS

—

Countries

India

Contacts

Public ContactDr SRIKUMAR V

AIIMS, NEW DELHI

srikumar.venkataraman@gmail.com

Outcome results

None listed

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