Efficacy of Platelet Rich Plasma Injection in Diabetic Neuropathy
Primary Purpose
Diabetic Peripheral Neuropathy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PRP injection
traditional medical treatment
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Peripheral Neuropathy
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
Sites / Locations
- Assuit University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PRP injection
medical treatment
Arm Description
Outcomes
Primary Outcome Measures
Numbness
modified Toronto Clinical Neuropathy Score
pain
VAS 0-10 scale
Secondary Outcome Measures
Conduction velocity
Meter/second
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03250403
Brief Title
Efficacy of Platelet Rich Plasma Injection in Diabetic Neuropathy
Official Title
Efficacy of Platelet Rich Plasma Injection in Diabetic Neuropathy: Double Blinded Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
October 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRP injection
Arm Type
Experimental
Arm Title
medical treatment
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
PRP injection
Intervention Description
peri-neural injection of platelet rich plasma
Intervention Type
Other
Intervention Name(s)
traditional medical treatment
Intervention Description
traditional medical treatment
Primary Outcome Measure Information:
Title
Numbness
Description
modified Toronto Clinical Neuropathy Score
Time Frame
6 months
Title
pain
Description
VAS 0-10 scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Conduction velocity
Description
Meter/second
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdelraheem M Alawaamy, Dr
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assuit University
City
Assiut
ZIP/Postal Code
7111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Efficacy of Platelet Rich Plasma Injection in Diabetic Neuropathy
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