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NCT Number: NCT06638008

Ultrasound Guided Placental Growth Factor Vs Platelet Rich Plasma Injection in Peripheral Nerve Injury: an Interventional Study

The goal of this clinical trial is to learn if placental growth factor injection and platelet rich plasma injection works to treat peripheral nerve injury in adults. and the role of nerve conduction study and neuromuscular ultrasound

The main questions it aims to answer are:

Does placental growth factor improve outcome after peripheral nerve injury? Does platelet rich plasma improve outcome after peripheral nerve injury? Researchers will compare drug both drugs to each other and will follow up the results via NCS and NMUS

Participants will be classified into 3 random groups:

one group will receive perineural injection of placental growth factor, the other group will receive peri neural PRP injection, third group will only be followed up without intervention Follow up of each patients will be done at 3 and 6 months

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Key information

Conditions

Peripheral Nerve Injury Upper Limb Nervous System Diseases Neuromuscular Diseases Peripheral Nerve Injuries Peripheral Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Traumatic nerve injuries, particularly involving the median and ulnar nerves, pose significant clinical challenges and can lead to considerable morbidity Neuropathic pain, which can arise from nerve lesions, may persist for months or even years after the apparent healing of the affected tissues , Moreover, weakness or paralysis of specific muscles can impair grip strength and fine motor skills, making daily tasks challenging, and the chronic disability affects patient's quality of life.

Neuromuscular US is a non-invasive technique to diagnose peripheral nerve injuries, basic findings in nerve trauma may include focal enlargements suggesting a neuroma in continuity, disorganization of the internal fascicular structure, as well as partial or complete nerve transection.

Growth factors play a pivotal role in the process of nerve regeneration by promoting cellular growth, survival, and differentiation.

Placenta extract contains a variety of growth factors, such as: Vascular Endothelial Growth Factor (VEGF), Transforming Growth Factor-beta (TGF-β), Fibroblast Growth factor (FGF) and insulin-like growth factor (IGF), It also includes cytokines and proteins that support healing and modulate inflammatory responses(6)placental extract use showed a significant improvement in pain and range of motion in knee osteoarthritis, Fibromyalgia and Rheumatoid arthritis (RA).

Another rich source of growth factors is platelet-rich plasma (PRP) it allows gradual and sustained release of neurotrophic signaling molecules such as nerve growth factor (NGF), Brain-Derived Neurotrophic Factor (BDNF), IGF-1, platelet-derived growth factor (PDGF), VEGF, and hepatocyte growth factor (HGF) and neurotropic factors (fibrin, fibronectin, and vitronectin) Studies on PRP and placental extract effect on nerve injuries are also still limited which needs further experimentation to understand its effect, and ability of regeneration of various neural components.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients older than 16 yrs old.
  • Patients with traumatic median or ulnar nerve injury who are complaining of symptoms or functional disability.
  • Patients with these injuries for more than 3 months

Exclusion criteria

  • 1- Presence of other causes of nerve affection (entrapment, Diabetes, etc).

Treatment and study plan

perineural injection

Drug

perineural intervention of placental growth factor in one group and PRP in other group

Primary outcomes

  1. efficacy of placental growth factor injection guided by ultrasound and nerve conduction

    Time frame: one year

    pre and post injection follow up will be done my measuring the nerve conduction velocity and amplitude , and by determining the cross sectional area of the nerve by ultrasound

  2. efficacy of platelet rich plasma injection guided by ultrasound and nerve conduction

    Time frame: one year

    pre and post injection parameters of nerve conduction as velocity and amplitude will be measured as will as parameters of ultrasound such as cross sectional area

Secondary outcomes

  1. diagnosis and follow up of patients by nerve conduction study and neuromuscular US

    Time frame: one year

    patients will undergo baseline NCS and NMUS and then follow up the outcome of injection at 3 and 6 months the following parameters will be measured : nerve conduction velocity and amplitude as well as cross sectional area of the nerve

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Taher Amin, assistant lecturer

CONTACT

[email protected]

+201111337547

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

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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