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Completed

NCT Number: NCT03601494

Perineural Platelet-rich Plasma for Diabetic Neuropathy Pain

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).

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emad Zarief Kamel Said

Asyut, 71111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

perineural injection of platelet-rich plasma

Other

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.

medical

Drug

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

Primary outcomes

  1. visual analog scale of pain

    Time frame: 6 months

    it will be measured by visual analog scale

Secondary outcomes

  1. Nerve conduction velocity

    Time frame: 6 months

    changes in nerve conduction velocities in meters/ seconds

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Perineural Platelet Rich Plasma for Pain and Disability Management in Diabetic Peripheral Neuropathy

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jul 26, 2018
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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