Ozone Therapy in Patients With Diabetic Neuropathy

Ozone Therapy in Clinical, Psychological and Neurophysiological Pain Alleviation in Patients With Diabetic Neuropathy

Diabetic neuropathies are the most prevalent chronic complications of diabetes mellitus. The early recognition and appropriate management of neuropathy in the patient with diabetes is important for patient's quality of life and life expectancy. Ozone is well known to have anti-inflammatory and analgesic effects through the inhibition of pro-inflammatory mediators; as well as. stimulation of anti-inflammatory mediators' release

Study Overview

• Status: Not yet recruiting
• Conditions: Pain, Chronic
• Intervention / Treatment: Drug: Ozone; Drug: Convtrol group

Detailed Description

Introduction:

Diabetic neuropathies are the most prevalent chronic complications of diabetes mellitus. The early recognition and appropriate management of neuropathy in the patient with diabetes is important for patient's quality of life and life expectancy. The clinical symptoms of DPN range from pain and burning sensations (at rest or at night) to hypoesthesia, paresthesia, and/or numbness . Diabetic neuropathy can be axonal or demyelinating and can affect large or small neurons. Schwann cells, which are the most abundant glial cells, act as nerve axon insulators and modulators of neurobiology through their role in metabolic support and injury protection. In diabetic patients, church cells' function is disturbed, leading to loss of glial-axon communication and nerve homeostasis, which leads to fiber loss, neurodegeneration, and pain. Nerve conduction studies can detect these changes; however, there has been no effective therapy for the treatment of DPN until now.

Ozone is well known to have anti-inflammatory and analgesic effects through the inhibition of pro-inflammatory mediators; as well as. stimulation of anti-inflammatory mediators' release . Previous studies showed that Ozone promotes peripheral vascular integrity via induction of Vascular Endothelial Growth Factor (VEGF), Transforming Growth Factor Beta (TGF-β1) an Platelet-Derived Growth Factor (PDGF), according with the studies of Professor Bocci that demonstrated significantly increase and release of PDGF, TGF- β1 and VEGF in presence of Ozone .

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emad Kamel, MD; Phone Number: +201007046058; Email: emadzarief@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Emad Zarief Kamel Said

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Sixty adult diabetic patients (type II DM)
• clinically symptomatized painful neuropathy for six or more months.

Exclusion Criteria:

• Patients with other causes of neuropathy (e.g., vitamin B12 deficiency), hereditary neuropathies and entrapment neuropathies, overt neuropathy with foot ulcers and/or amputation, peripheral vascular diseases, vertebral pathologies (e.g., previous surgery, foraminal stenosis, spinal canal stenosis, and/or vertebral disc herniation)
• Patients with other medical conditions such as connective tissue diseases, thyroid disorders, significant renal or hepatic dysfunction, platelet dysfunction syndrome, critical thrombocytopenia, hemodynamic instability and septicemia
• local infection at the site of the procedure
• Consistent use of nonsteroidal anti-inflammatory drugs within the last two weeks
• Systemic corticosteroid administration or local injection at the suspected treatment site within the last month
• Recent fever or illness, hemoglobin level <10 g/dL, platelet count <105 _ 109/L, and/or tobacco use.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ozone group; Ozone injection under ultrasound guidance in addition to the medical treatment	Drug: Ozone; The participants will lay flat and the area of injection will be prepared with antiseptic. Maintenance of ultrasonography probe sterility was also guaranteed using a sterile barrier. Under sonographic guidance, superficial peroneal nerve, deep peroneal, sural , asphenous, and tibila nerves will be injected An ozone/oxygen mixture ( 25μg/ml) will be injected in each nerev
Other: control group; receive the medical treatment only. The medical treatment includes optimal glycemic control, vitamin B complex, a lipoic acid, selective serotonin reuptake inhibitors, and pregabalin	Drug: Convtrol group; The medical treatment included optimal glycemic control, vitamin B complex, a lipoic acid, selective serotonin reuptake inhibitors, and pregabalin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Assessment	the visual analoge scale of pain (VAS) will be assessed. No pain VAS = 1, worst pain VAS= 10	6 months

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Bril V, Tomioka S, Buchanan RA, Perkins BA; mTCNS Study Group. Reliability and validity of the modified Toronto Clinical Neuropathy Score in diabetic sensorimotor polyneuropathy. Diabet Med. 2009 Mar;26(3):240-6. doi: 10.1111/j.1464-5491.2009.02667.x.
• Bocci V, Zanardi I, Travagli V. Ozone: a new therapeutic agent in vascular diseases. Am J Cardiovasc Drugs. 2011;11(2):73-82. doi: 10.2165/11539890-000000000-00000.
• Hassanien M, Elawamy A, Kamel EZ, Khalifa WA, Abolfadl GM, Roushdy ASI, El Zohne RA, Makarem YS. Perineural Platelet-Rich Plasma for Diabetic Neuropathic Pain, Could It Make a Difference? Pain Med. 2020 Apr 1;21(4):757-765. doi: 10.1093/pm/pnz140.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 25, 2022
• Primary Completion (Anticipated): August 30, 2022
• Study Completion (Anticipated): September 20, 2022

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Chronic Pain; Diabetic Neuropathies
• Other Study ID Numbers: IRB20025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No