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

January 29, 2026 updated by: Fatima Numeri, Services Institute of Medical Sciences, Pakistan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan
        • Services Hospital Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologous Platelet-Rich Plasma Dressings
Approximately 10 mL of venous blood is processed to prepare PRP, which is applied as a wound dressing for 3 days. Applied for about 4 weeks, with follow-up until 12 weeks.
Biological: Autologous Platelet-Rich Plasma (PRP) Dressing
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.
Active Comparator: Normal Saline Dressing
Conventional sterile saline dressings are applied daily over ~4 weeks, with follow-up until 12 weeks.
Other: Normal Saline Dressings
Conventional sterile normal saline dressings are applied over ~4 weeks, with outpatient follow-up until 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound Healing Status
Time Frame: Up to 12 weeks
Wound status based on presence of granulation tissue and measurement of wound size.
Up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of healing
Time Frame: Up to 12 weeks
Number of days from baseline until there is no further change in wound size.
Up to 12 weeks
Percentage Change in Longitudinal Wound Dimension
Time Frame: 12 weeks
Calculated as (baseline longitudinal size - size at 12 weeks) ÷ baseline longitudinal size × 100.
12 weeks
Percentage Change in Horizontal Wound Dimension
Time Frame: 12 weeks
Calculated as (baseline horizontal size-sizeat12weeks)÷base line horizontal size X 100
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Services Institute of Medical Sciences, Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2024

Primary Completion (Actual)

April 30, 2025

Study Completion (Actual)

April 30, 2025

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB/2023/1091/SIMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data collected in this study will not be shared outside the study team to protect participant privacy and in accordance with local regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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