Efficacy of Platelet Rich Plasma Injection in Diabetic Neuropathy

NCT ID: NCT03250403

Last Updated: 2018-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2017-10-01

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

Conditions

Diabetic Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

PRP injection

Group Type: EXPERIMENTAL

PRP injection

Intervention Type: DRUG

peri-neural injection of platelet rich plasma

traditional medical treatment

Intervention Type: OTHER

traditional medical treatment

medical treatment

Group Type: ACTIVE_COMPARATOR

traditional medical treatment

Intervention Type: OTHER

traditional medical treatment

Interventions

PRP injection

peri-neural injection of platelet rich plasma

Intervention Type: DRUG

traditional medical treatment

traditional medical treatment

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Manal Hassanien

Prenciple investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdelraheem M Alawaamy, Dr

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Assuit University

Asyut, , Egypt

Countries

Egypt

Other Identifiers

peripheral neuropathy PRP

Identifier Type: -

Identifier Source: org_study_id