Perineural Platelet-rich Plasma for Diabetic Neuropathy Pain

Not Applicable

Completed

• Conditions: Diabetic Neuropathies; Chronic Pain
• Interventions: Other: perineural injection of platelet-rich plasma; Drug: medical

• Registration Number: NCT03601494
• Lead Sponsor: Assiut University

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).

Detailed 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.

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2017-11-22
• Study Completion: 2018-02-18
• Status Verified: 2018-07
• Study First Submitted: 2018-07-12
• Study First Submitted QC: 2018-07-24
• Last Update Submitted: 2018-07-24
• Study First Posted: 2018-07-26
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	perineural injection of platelet-rich plasma	peri-neural platelet rich plasma injection under ultrasound guidance in addition to medical treatment.
Intervention	medical	peri-neural platelet rich plasma injection under ultrasound guidance in addition to medical treatment.
Control	medical	medical treatment only

Primary Outcome Measures

Name	Time	Method
visual analog scale of pain	6 months	it will be measured by visual analog scale

Secondary Outcome Measures

Name	Time	Method
Nerve conduction velocity	6 months	changes in nerve conduction velocities in meters/ seconds

Trial Locations

Locations (1)

Emad Zarief Kamel Said; 🇪🇬 Assiut, Egypt