Perineural Platelet-rich Plasma for Diabetic Neuropathy Pain

NCT03601494 | Completed DMC

• 1 other identifier: IRB00009919
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Diabetic Neuropathies; Chronic Pain

Keywords

Diabetic Neuropathies; Chronic pain

Outcome Measures

Primary Outcomes (1)

• visual analog scale of pain

  it will be measured by visual analog scale

  6 months

Secondary Outcomes (1)

• Nerve conduction velocity

  6 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

peri-neural platelet rich plasma injection under ultrasound guidance in addition to medical treatment.

Other: perineural injection of platelet-rich plasma; Drug: medical

Control

PLACEBO COMPARATOR

medical treatment only

Drug: medical

Interventions

perineural injection of platelet-rich plasma OTHER

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.

Intervention

medical DRUG

vitamin B complex, α lipoic acid, selective serotonin reuptake inhibitor (SSRI)

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• type II diabetes mellitus
• diabetic peripheral neuropathy
• six months duration of symptoms,

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Emad Zarief Kamel Said

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Chronic Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 26, 2018
• Study Start: February 1, 2017
• Primary Completion: November 22, 2017
• Study Completion: February 18, 2018
• Last Updated: July 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)