CClinicalTrials.gg
CompletedNCT07377708Updated Feb 2, 2026

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

An interventional study of Autologous Platelet-Rich Plasma (PRP) Dressing and Normal Saline Dressings in Wheel Spoke Injury, Heel Pad Injuries and Wound Healing, sponsored by Services Institute of Medical Sciences, Pakistan. Completed at 1 site in Pakistan. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-02-02.

Sponsored by Services Institute of Medical Sciences, Pakistan · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Apr 2024, registered Jan 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Wheel Spoke Injury
  • Heel Pad Injuries
  • Wound Healing

Keywords

  • Platelet Rich Plasma (PRP)
  • Saline Dressing
  • Wound Care Trauma - Pediatric
  • Motorcycle Injuries
  • Soft Tissue Repair
  • Pediatric Surgery
03

In context

Lead sponsor

Services Institute of Medical Sciences, Pakistan is the lead sponsor of 33 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria :

  • Children with wounds older than 3 weeks
  • Children with wounds resulting from comorbidities
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BiologicalAutologous 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.

  • OtherNormal Saline Dressings

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

06

What researchers measure

Primary outcomes

  1. Wound Healing Status

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

    Time frame: Up to 12 weeks

Secondary outcomes

  1. Duration of healing

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

    Time frame: Up to 12 weeks

  2. Percentage Change in Longitudinal Wound Dimension

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

    Time frame: 12 weeks

  3. Percentage Change in Horizontal Wound Dimension

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

    Time frame: 12 weeks

07

Study locations

1 site
  • Services Hospital Lahore
    Lahore, Punjab Province, Pakistan
08

References and documents

Publications

  • Somani A, Rai R. Comparison of Efficacy of Autologous Platelet-rich Fibrin versus Saline Dressing in Chronic Venous Leg Ulcers: A Randomised Controlled Trial. J Cutan Aesthet Surg. 2017 Jan-Mar;10(1):8-12. doi: 10.4103/JCAS.JCAS_137_16. PubMed 28529414 ↗
  • Elsaid A, El-Said M, Emile S, Youssef M, Khafagy W, Elshobaky A. Randomized Controlled Trial on Autologous Platelet-Rich Plasma Versus Saline Dressing in Treatment of Non-healing Diabetic Foot Ulcers. World J Surg. 2020 Apr;44(4):1294-1301. doi: 10.1007/s00268-019-05316-0. PubMed 31811339 ↗

Individual participant data

Plan to share: No — 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07377708
Lead sponsor
Services Institute of Medical Sciences, Pakistan
Responsible party
Fatima Numeri (Professor and Head of Pediatric Surgery Department, Services Institute of Medical Sciences, Pakistan) — Principal investigator
First posted
Jan 30, 2026
Start date
Apr 16, 2024
Primary completion
Apr 30, 2025
Completion
Apr 30, 2025
Last update
Feb 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion