Perineural Platelet-rich Plasma for Diabetic Neuropathy Pain

Chronic Pain Clinical Trial

Official title:

Perineural Platelet Rich Plasma for Pain and Disability Management in Diabetic Peripheral Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03601494
• Other study ID #: IRB00009919
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: February 18, 2018

Study information

• Verified date: July 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Peripheral neuropathy is very common in diabetes mellitus (DM). Till now there is no available effective therapy for this pathology. Objective: To evaluate the clinical effect of perineural platelet-rich plasma (PRP) injection as a treatment of diabetic peripheral neuropathy (DPN).

Description:

Diabetic Peripheral neuropathy (DPN) is a common complication of diabetes mellitus (DM). Among several complications that contribute to reduce patient's quality of life and life expectancy diabetic neuropathy (DN) generalized or focal leads to an impaired life quality.

The clinical symptoms of DPN range from pain and burning sensations, more at rest or at night; to hypoesthesia or paresthesia, and or numbness.

Different types of peripheral neuropathy are observed in diabetes, axonal or demyelination or both can be present, involves myelinated and un-myelinated, large and small fibers. Nerve conduction studies can detect these changes. Till now, there is no effective therapy for the treatment of DPN.

Since 1950 Platelet-rich plasma (PRP) has been used in dermatology and oral maxillofacial surgery, but its role as an effective alternative treatment in many other clinical applications has been increased over the last years.

Platelets contain more than 1100 proteins, include enzymes, enzyme inhibitors, growth factors, immune messengers, and other bioactive compounds which play a role in tissue repair and wound healing.

Autologous platelet-rich plasma found to promote axon regeneration in studies involving animal models. Platelet derived angiogenesis factors are capable of stimulating new capillary growth by inducing migration of endothelial cells. It was suggested that this was the mechanism by which platelet factors influence the process of angiogenesis and revascularization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 18, 2018
• Est. primary completion date: November 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• type II diabetes mellitus

• diabetic peripheral neuropathy

• six months duration of symptoms,

Exclusion Criteria:

• other causes of neuropathy

• patient refusal

• ulcers or amputations

• peripheral vascular diseases

• vertebral spine disease

• connective tissue disease

• platelet dysfunction syndrome

• critical thrombocytopenia

• local infection

• coagulopathy

Related Conditions & MeSH terms

• Chronic Pain
• Diabetic Neuropathies
• Peripheral Nervous System Diseases

Intervention

Other:
• perineural injection of platelet-rich plasma
Sonographic guided injection was done under complete sterile conditions including skin sterilization, ultrasound probe covered with sterile pad, and a sterile gel. The needle was introduced from the lateral side toward midline using the in-plane approach to target the desired nerve, each nerve was injected by a single dose of 1.5 cc of PRP. Free hand one-man technique was used by the physician who simultaneously managed the ultrasound device by holding the syringe with one hand while scanning the nerve by moving the probe with the other hand. With continuous imaging of the tip of the needle, the syringe was put around the nerve and platelet-rich plasma was injected in the peri-neural tissue.

Drug:
• medical
vitamin B complex, a lipoic acid, selective serotonin reuptake inhibitor (SSRI)

Locations

Country	Name	City	State
Egypt	Emad Zarief Kamel Said	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analog scale of pain	it will be measured by visual analog scale	6 months
Secondary	Nerve conduction velocity	changes in nerve conduction velocities in meters/ seconds	6 months