Efficacy of Platelet Rich Plasma Injection in Diabetic Neuropathy

Not Applicable

Completed

• Conditions: Diabetic Peripheral Neuropathy
• Interventions: Drug: PRP injection; Other: traditional medical treatment

• Registration Number: NCT03250403
• Lead Sponsor: Assiut University

Brief Summary

To evaluate the clinical efficacy and safety of peri-neural platelet rich plasma (PRP) injection in the treatment of diabetic peripheral neuropathy compared to traditional medical treatment.

Detailed Description

Background: Neuropathy is a common complication of diabetes mellitus (DM) with a wide clinical spectrum that encompasses generalized to focal and multifocal forms not only leads to an impaired quality of life, but also to an increased morbidity and mortality . Till now there is no available effective therapy for the treatment of diabetic peripheral neuropathy (DPN). Autologous platelet-rich plasma is easy and cost-effective method as it provides necessary growth factors that promote wound healing/growth, angiogenesis, and axon regeneration .

Objective: To evaluate the clinical efficacy and safety of peri-neural platelet rich plasma (PRP) injection in the treatment of diabetic peripheral neuropathy compared to traditional medical treatment.

Method : Prospective double blinded randomized controlled trial was conducted . All included patients had type 2 DM selected from Endocrinology unit Department of Internal medicine, Assuit university Hospital, Egypt . DPN of at least 5 years duration of symptoms . Patients with other causes of neuropathy like hereditary neuropathies , entrapment neuropathies ,connective tissue diseases , vertebral diseases ,thyroid disorders and end organ failure were excluded . Neuropathy was assessed by the modified Toronto Clinical Neuropathy Score (mTCNS) 2001 (3) , Baseline pain and nerve conduction studies were done. Then they were double blindly divided into two groups, Group I underwent PRP preineural injection under ultrasound guidance plus medical treatment . Group װreceived medical treatment only( control group) . Blood glucose was strictly controlled in both groups . Patients were followed every month for 3 months by mTCNS and by nerve conduction studies. Results were expressed as means ± standard deviation or frequencies. Independent Student's t test was done for comparison between groups

Study Timeline

• Study Start: 2017-04-01
• Primary Completion: 2017-08-01
• Study First Submitted: 2017-08-08
• Study First Submitted QC: 2017-08-14
• Study First Posted: 2017-08-15
• Study Completion: 2017-10-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-12
• Last Update Posted: 2018-07-13

Recruitment & Eligibility

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

Inclusion Criteria

• Diabetic peripheral neuropathy of at least 5 years duration of symptoms

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Exclusion Criteria

• hereditary neuropathies , entrapment neuropathies , connective tissue diseases , vertebral diseases , thyroid disorders and end organ failure

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRP injection	PRP injection	-
PRP injection	traditional medical treatment	-
medical treatment	traditional medical treatment	-

Primary Outcome Measures

Name	Time	Method
Numbness	6 months	modified Toronto Clinical Neuropathy Score
pain	6 months	VAS 0-10 scale

Secondary Outcome Measures

Name	Time	Method
Conduction velocity	6 months	Meter/second

Trial Locations

Locations (1)

Assuit University; 🇪🇬 Assiut, Egypt