Clinical Trials Directory

Trials / Completed

CompletedNCT07377708

Platelet-Rich Plasma Versus Saline Dressings in Pediatric Heel Pad Injuries

A Comparison of Autologous Platelet-Rich Plasma Dressing Versus Saline Dressing in the Management of Pediatric Heel Pad Injuries Due to Motorcycle Wheel-Spoke Trauma

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Services Institute of Medical Sciences, Pakistan · Other Government
Sex
All
Age
5 Years – 12 Years
Healthy volunteers
Not accepted

Summary

This study is testing whether autologous platelet rich plasma (PRP) dressings are more effective than normal saline dressings in treating heel pad injuries caused by motorcycle wheel spokes among children in Pakistan. PRP is prepared from a child's own blood and contains natural growth factors that may help wounds to heal faster. The study compares healing rates, reduction in wound size, and time to complete wound healing between the platelet-rich plasma and saline dressing groups.

Detailed description

Motorcycle wheel-spoke injuries occur when the heel or foot becomes entrapped in the spokes of a moving motorcycle, frequently resulting in severe soft tissue damage in children. Healing of these injuries is often prolonged and challenging. Platelet-rich plasma (PRP), prepared from a patient's own blood, contains a high concentration of growth factors that promote tissue regeneration, angiogenesis, and wound contraction. Previous studies in adults with diabetic and chronic ulcers have demonstrated that PRP may accelerate wound healing compared with conventional dressings. However, evidence supporting the use of PRP in the pediatric population, particularly for heel pad injuries resulting from motorcycle wheel-spoke trauma, remains limited. This randomized controlled trial is designed to evaluate the efficacy of platelet-rich plasma dressing compared with saline dressing in children aged 5 to 12 years presenting with heel pad injuries. A total of 60 participants will be enrolled and randomly assigned to receive either platelet-rich plasma dressing or saline dressing. Study outcomes will include wound healing within 12 weeks, duration of wound healing in days, and changes in wound size measured in both longitudinal and horizontal dimensions. This trial aims to generate evidence for a more effective and locally feasible wound management strategy for pediatric heel pad injuries in the study setting.

Conditions

Interventions

TypeNameDescription
BIOLOGICALAutologous Platelet-Rich Plasma (PRP) DressingApproximately 10 mL of venous blood is processed in the pathology department to prepare PRP, which is applied as a wound dressing. Dressings are applied over \~4 weeks, with outpatient follow-up until 12 weeks.
OTHERNormal Saline DressingsConventional sterile normal saline dressings are applied over \~4 weeks, with outpatient follow-up until 12 weeks.

Timeline

Start date
2024-04-16
Primary completion
2025-04-30
Completion
2025-04-30
First posted
2026-01-30
Last updated
2026-02-02

Locations

1 site across 1 country: Pakistan

Source: ClinicalTrials.gov record NCT07377708. Inclusion in this directory is not an endorsement.