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Ozone Therapy in Patients With Diabetic Neuropathy

Primary Purpose

Pain, Chronic

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ozone
Convtrol group
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Chronic

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Emad Zarief Kamel Said

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

ozone group

control group

Arm Description

Ozone injection under ultrasound guidance in addition to the medical treatment

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

Outcomes

Primary Outcome Measures

Pain Assessment
the visual analoge scale of pain (VAS) will be assessed. No pain VAS = 1, worst pain VAS= 10

Secondary Outcome Measures

Full Information

First Posted
August 4, 2021
Last Updated
January 4, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05000463
Brief Title
Ozone Therapy in Patients With Diabetic Neuropathy
Official Title
Ozone Therapy in Clinical, Psychological and Neurophysiological Pain Alleviation in Patients With Diabetic Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 25, 2022 (Anticipated)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
September 20, 2022 (Anticipated)

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
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
ozone group
Arm Type
Active Comparator
Arm Description
Ozone injection under ultrasound guidance in addition to the medical treatment
Arm Title
control group
Arm Type
Other
Arm Description
receive the medical treatment only. The medical treatment includes optimal glycemic control, vitamin B complex, a lipoic acid, selective serotonin reuptake inhibitors, and pregabalin
Intervention Type
Drug
Intervention Name(s)
Ozone
Intervention Description
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
Intervention Name(s)
Convtrol group
Intervention Description
The medical treatment included optimal glycemic control, vitamin B complex, a lipoic acid, selective serotonin reuptake inhibitors, and pregabalin.
Primary Outcome Measure Information:
Title
Pain Assessment
Description
the visual analoge scale of pain (VAS) will be assessed. No pain VAS = 1, worst pain VAS= 10
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emad Kamel, MD
Phone
+201007046058
Email
emadzarief@aun.edu.eg
Facility Information:
Facility Name
Emad Zarief Kamel Said
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
21446774
Citation
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.
Results Reference
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PubMed Identifier
19317818
Citation
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.
Results Reference
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PubMed Identifier
31298289
Citation
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.
Results Reference
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Ozone Therapy in Patients With Diabetic Neuropathy

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