Ozone Therapy in Patients With Diabetic Neuropathy

NCT ID: NCT05000463

Last Updated: 2022-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-25
• Study Completion Date: 2022-09-20

Brief Summary

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

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 .

Conditions

Pain, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ozone group

Ozone injection under ultrasound guidance in addition to the medical treatment

Group Type: ACTIVE_COMPARATOR

Ozone

Intervention Type: DRUG

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

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

Group Type: OTHER

Convtrol group

Intervention Type: DRUG

The medical treatment included optimal glycemic control, vitamin B complex, a lipoic acid, selective serotonin reuptake inhibitors, and pregabalin.

Interventions

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

Intervention Type: DRUG

Convtrol group

The medical treatment included optimal glycemic control, vitamin B complex, a lipoic acid, selective serotonin reuptake inhibitors, and pregabalin.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Emad Zarief , MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Emad Zarief Kamel Said

Asyut, , Egypt

Countries

Egypt

Central Contacts

Emad Kamel, MD

Role: CONTACT

emadzarief@aun.edu.eg

+201007046058

References

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.

Reference Type: BACKGROUND

PMID: 21446774 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19317818 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31298289 (View on PubMed)

Other Identifiers

IRB20025

Identifier Type: -

Identifier Source: org_study_id