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Perineural Platelet-rich Plasma for Diabetic Neuropathy Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03601494
Recruitment Status : Completed
First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Emad Zarief , MD, 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).

Condition or disease Intervention/treatment Phase
Diabetic Neuropathies Chronic Pain Other: perineural injection of platelet-rich plasma Drug: medical Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Perineural Platelet Rich Plasma for Pain and Disability Management in Diabetic Peripheral Neuropathy
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : November 22, 2017
Actual Study Completion Date : February 18, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intervention
peri-neural platelet rich plasma injection under ultrasound guidance in addition to medical treatment.
Other: perineural injection of platelet-rich plasma
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.

Drug: medical
vitamin B complex, α lipoic acid, selective serotonin reuptake inhibitor (SSRI)

Placebo Comparator: Control
medical treatment only
Drug: medical
vitamin B complex, α lipoic acid, selective serotonin reuptake inhibitor (SSRI)




Primary Outcome Measures :
  1. visual analog scale of pain [ Time Frame: 6 months ]
    it will be measured by visual analog scale


Secondary Outcome Measures :
  1. Nerve conduction velocity [ Time Frame: 6 months ]
    changes in nerve conduction velocities in meters/ seconds



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601494


Locations
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Egypt
Emad Zarief Kamel Said
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University

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Responsible Party: Emad Zarief , MD, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT03601494    
Other Study ID Numbers: IRB00009919
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emad Zarief , MD, Assiut University:
Diabetic Neuropathies
Chronic pain
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Chronic Pain
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases