Viewing Study NCT06638008



Ignite Creation Date: 2024-10-26 @ 3:42 PM
Last Modification Date: 2024-10-26 @ 3:42 PM
Study NCT ID: NCT06638008
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-10-04

Brief Title: Ultrasound Guided Placental Growth Factor Vs Platelet Rich Plasma Injection in Peripheral Nerve Injury an Interventional Study
Sponsor: None
Organization: None

Study Overview

Official Title: Ultrasound Guided Placental Growth Factor Vs Platelet Rich Plasma Injection in Peripheral Nerve Injury an Interventional Study
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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 patients 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 responses6placental 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None