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Completed

NCT Number: NCT07377708

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

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.

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Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Services Hospital Lahore

Lahore, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 5-12 years
  • Both genders
  • Presenting with heel pad injuries caused by motorcycle wheel-spoke trauma

Exclusion criteria

  • Children with wounds older than 3 weeks
  • Children with wounds resulting from comorbidities

Treatment and study plan

Autologous Platelet-Rich Plasma (PRP) Dressing

Biological

Approximately 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.

Normal Saline Dressings

Other

Conventional sterile normal saline dressings are applied over ~4 weeks, with outpatient follow-up until 12 weeks.

Primary outcomes

  1. Wound Healing Status

    Time frame: Up to 12 weeks

    Wound status based on presence of granulation tissue and measurement of wound size.

Secondary outcomes

  1. Duration of healing

    Time frame: Up to 12 weeks

    Number of days from baseline until there is no further change in wound size.

  2. Percentage Change in Longitudinal Wound Dimension

    Time frame: 12 weeks

    Calculated as (baseline longitudinal size - size at 12 weeks) ÷ baseline longitudinal size × 100.

  3. Percentage Change in Horizontal Wound Dimension

    Time frame: 12 weeks

    Calculated as (baseline horizontal size-sizeat12weeks)÷base line horizontal size X 100

Sponsors and collaborators

Lead sponsor

Services Institute of Medical Sciences, Pakistan

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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