Wheel Spoke InjuryNCT07377708
Platelet-Rich Plasma Versus Saline Dressings in Pediatric Heel Pad Injuries
A study testing Autologous Platelet-Rich Plasma (PRP) Dressing and Normal Saline Dressings in people with Wheel Spoke Injury and Heel Pad Injuries, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Wheel Spoke Injury, Heel Pad Injuries, Wound Healing
- What is being tested?
- Autologous Platelet-Rich Plasma (PRP) Dressing and Normal Saline Dressings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Apr 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5-12 years
- Both genders
- Presenting with heel pad injuries caused by motorcycle wheel-spoke trauma
Who cannot join
- Children with wounds older than 3 weeks
- Children with wounds resulting from comorbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Wheel Spoke Injury, Heel Pad Injuries, Wound Healing
- Being tested
- Autologous Platelet-Rich Plasma (PRP) Dressing, Normal Saline Dressings
- Keywords
- Platelet Rich Plasma (PRP), Saline Dressing, Wound Care Trauma - Pediatric, Motorcycle Injuries, Soft Tissue Repair, Pediatric Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Platelet-Rich Plasma (PRP) DressingBiological
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 DressingsOther
Conventional sterile normal saline dressings are applied over ~4 weeks, with outpatient follow-up until 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Platelet-Rich Plasma Dressings | Experimental | 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. Receives: Biological: Autologous Platelet-Rich Plasma (PRP) Dressing |
| Normal Saline Dressing | Active comparator | Conventional sterile saline dressings are applied daily over ~4 weeks, with follow-up until 12 weeks. Receives: Other: Normal Saline Dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing Status
Wound status based on presence of granulation tissue and measurement of wound size.
Measured: Up to 12 weeks
Secondary outcomes (3)
Duration of healing
Number of days from baseline until there is no further change in wound size.
Measured: Up to 12 weeks
Percentage Change in Longitudinal Wound Dimension
Calculated as (baseline longitudinal size - size at 12 weeks) ÷ baseline longitudinal size × 100.
Measured: 12 weeks
Percentage Change in Horizontal Wound Dimension
Calculated as (baseline horizontal size-sizeat12weeks)÷base line horizontal size X 100
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start16 Apr 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Wheel Spoke InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm randomized controlled trial, 1:1 allocation by lottery method (PRP dressing vs normal saline dressing).
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Institute of Medical Sciences, Pakistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatima Numeri, Services Institute of Medical Sciences, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377708
- Sponsor's protocol ID
- IRB/2023/1091/SIMS
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 28529414Elsaid 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07377708
- Acronym / sponsor ID
- IRB/2023/1091/SIMS
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Services Institute of Medical Sciences, PakistanOther government
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm randomized controlled trial, 1:1 allocation by lottery method (PRP dressing vs normal saline dressing).
| Arm | Type | Receives |
|---|---|---|
| Autologous Platelet-Rich Plasma Dressings | Experimental | Biological: Autologous Platelet-Rich Plasma (PRP) DressingApproximately 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. |
| Normal Saline Dressing | Active comparator | Other: Normal Saline DressingsConventional sterile saline dressings are applied daily over ~4 weeks, with follow-up until 12 weeks. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 5-12 years
- Both genders
- Presenting with heel pad injuries caused by motorcycle wheel-spoke trauma
Key exclusion criteria (2 listed)
- Children with wounds older than 3 weeks
- Children with wounds resulting from comorbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous 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. | Biological | Autologous Platelet-Rich Plasma Dressings |
| Normal Saline DressingsConventional sterile normal saline dressings are applied over ~4 weeks, with outpatient follow-up until 12 weeks. | Other | Normal Saline Dressing |
Primary outcome
Wound Healing Status
Time frame: Up to 12 weeks
Wound status based on presence of granulation tissue and measurement of wound size.
3 secondary outcomes
Duration of healing
Time frame: Up to 12 weeks
Percentage Change in Longitudinal Wound Dimension
Time frame: 12 weeks
Percentage Change in Horizontal Wound Dimension
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Background: PubMed 28529414Somani 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.
- Background: PubMed 31811339Elsaid 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.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Platelet-Rich Plasma (PRP) Dressing and Normal Saline Dressings in people with Wheel Spoke Injury and Heel Pad Injuries, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Healing Status (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07377708, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.