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Perineural Platelet-rich Plasma for Diabetic Neuropathy Pain

Primary Purpose

Diabetic Neuropathies, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
perineural injection of platelet-rich plasma
medical
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathies focused on measuring Diabetic Neuropathies, Chronic pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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

Sites / Locations

  • Emad Zarief Kamel Said

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

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

medical treatment only

Outcomes

Primary Outcome Measures

visual analog scale of pain
it will be measured by visual analog scale

Secondary Outcome Measures

Nerve conduction velocity
changes in nerve conduction velocities in meters/ seconds

Full Information

First Posted
July 12, 2018
Last Updated
July 24, 2018
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03601494
Brief Title
Perineural Platelet-rich Plasma for Diabetic Neuropathy Pain
Official Title
Perineural Platelet Rich Plasma for Pain and Disability Management in Diabetic Peripheral Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
November 22, 2017 (Actual)
Study Completion Date
February 18, 2018 (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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies, Chronic Pain
Keywords
Diabetic Neuropathies, Chronic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
peri-neural platelet rich plasma injection under ultrasound guidance in addition to medical treatment.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
medical treatment only
Intervention Type
Other
Intervention Name(s)
perineural injection of platelet-rich plasma
Intervention Description
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 Type
Drug
Intervention Name(s)
medical
Intervention Description
vitamin B complex, α lipoic acid, selective serotonin reuptake inhibitor (SSRI)
Primary Outcome Measure Information:
Title
visual analog scale of pain
Description
it will be measured by visual analog scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Nerve conduction velocity
Description
changes in nerve conduction velocities in meters/ seconds
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: type II diabetes mellitus diabetic peripheral neuropathy six months duration of symptoms, 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
Facility Information:
Facility Name
Emad Zarief Kamel Said
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Perineural Platelet-rich Plasma for Diabetic Neuropathy Pain

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