Peripheral Nerve Injury Upper LimbNCT06638008
Ultrasound Guided Placental Growth Factor Vs Platelet Rich Plasma Injection in Peripheral Nerve Injury: an Interventional Study
A study testing perineural injection in people with Peripheral Nerve Injury Upper Limb, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Peripheral Nerve Injury Upper Limb
- What is being tested?
- perineural injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2025to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1- Presence of other causes of nerve affection (entrapment, Diabetes, etc).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this 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:
Read more
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
Read the 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 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.
- Conditions
- Peripheral Nerve Injury Upper Limb
- Being tested
- perineural injection
- Keywords
- peripheral nerve injury, median and ulnar nerves, nerve conduction study, neuromuscular ultrasound, placental growth factor, perineural injection, platelet rich plasma
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perineural injectionDrug
perineural intervention of placental growth factor in one group and PRP in other group
| Study group | Role | What they receive |
|---|---|---|
| group will receive placental growth factor injection | Experimental | Not described Receives: Drug: perineural injection |
| group will receive platelet rich plasma injection | Experimental | Not described Receives: Drug: perineural injection |
| group with only follow up | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of placental growth factor injection guided by ultrasound and nerve conduction
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
Measured: one year
efficacy of platelet rich plasma injection guided by ultrasound and nerve conduction
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
Measured: one year
Secondary outcomes (1)
diagnosis and follow up of patients by nerve conduction study and neuromuscular US
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Jan 2025 (estimated)
- Primary completion15 Jan 2026 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve Injury Upper LimbStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Taher Mohamed Amin, Assiut University
- Investigators
- Essam Ahmed Abda, professor, Principal investigator, professor of Rheumatology, Rehabilitation and physical medicineMohammed Raouf Abd El-razik, Assistant professor, Study director, Assistant professor of Rheumatology, Rehabilitation and physical medicineAmira Mostafa El-sonbaty, lecturer, Study director, lecturer of Rheumatology, Rehabilitation and physical medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638008
- Sponsor's protocol ID
- Sara thesis
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Placental Growth Factor Vs Platelet Rich Plasma Injection in Peripheral Nerve Injury: an Interventional Study
- ClinicalTrials.gov ID
- NCT06638008
- Acronym / sponsor ID
- Sara thesis
- Conditions
- Peripheral Nerve Injury Upper Limb
- Keywords
- peripheral nerve injury, median and ulnar nerves, nerve conduction study, neuromuscular ultrasound, placental growth factor, perineural injection, platelet rich plasma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 15 Oct 2024 (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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group will receive placental growth factor injection | Experimental | Drug: perineural injection |
| group will receive platelet rich plasma injection | Experimental | Drug: perineural injection |
| group with only follow up | No intervention | – |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 1- Presence of other causes of nerve affection (entrapment, Diabetes, etc).
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 |
|---|---|---|
| perineural injectionperineural intervention of placental growth factor in one group and PRP in other group | Drug | group will receive placental growth factor injection, group will receive platelet rich plasma injection |
Primary outcome
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
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
1 secondary outcome
diagnosis and follow up of patients by nerve conduction study and neuromuscular US
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Essam Ahmed Abda, professor principal investigator
professor of Rheumatology, Rehabilitation and physical medicine
Mohammed Raouf Abd El-razik, Assistant professor study director
Assistant professor of Rheumatology, Rehabilitation and physical medicine
Amira Mostafa El-sonbaty, lecturer study director
lecturer of Rheumatology, Rehabilitation and physical medicine
Questions about this trial
What is this clinical trial studying?
A study testing perineural injection in people with Peripheral Nerve Injury Upper Limb, run by Assiut University.
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 1 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: opening soon, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Taher Amin, assistant lecturer (+201111337547, Sarataher.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of placental growth factor injection guided by ultrasound and nerve conduction (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.