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

Services Institute of Medical Sciences, Pakistan

Status: Completed

Conditions: Heel Pad Injuries; Wheel Spoke Injury; Wound Healing

Treatments: Biological: Autologous Platelet-Rich Plasma (PRP) Dressing; Other: Normal Saline Dressings

Study type: Interventional

Funder types: Other

Identifiers

NCT07377708

IRB/2023/1091/SIMS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Autologous Platelet-Rich Plasma Dressings

Experimental group

Description:

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.

Treatment:

Biological: Autologous Platelet-Rich Plasma (PRP) Dressing

Normal Saline Dressing

Active Comparator group

Description:

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

Treatment:

Other: Normal Saline Dressings