NCT05000463

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

February 25, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
Last Updated

January 5, 2022

Status Verified

January 1, 2022

Enrollment Period

6 months

First QC Date

August 4, 2021

Last Update Submit

January 4, 2022

Conditions

Pain, Chronic

Outcome Measures

Primary Outcomes (1)

  • Pain Assessment

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

    6 months

Study Arms (2)

ozone group

ACTIVE COMPARATOR

Ozone injection under ultrasound guidance in addition to the medical treatment

Drug: Ozone

control group

OTHER

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

Interventions

OzoneDRUG

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

ozone group
Convtrol groupDRUG

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

control group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emad Zarief Kamel Said

Asyut, 71111, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 21446774BACKGROUND

  • 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.

    PMID: 19317818BACKGROUND

  • 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.

    PMID: 31298289BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Interventions

Ozone

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OxygenGasesInorganic Chemicals

Central Study Contacts

Emad Kamel, MD

CONTACT

+201007046058emadzarief@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 4, 2021

First Posted

August 11, 2021

Study Start

February 25, 2022

Primary Completion

August 30, 2022

Study Completion

September 20, 2022

Last Updated

January 5, 2022

Record last verified: 2022-01

Locations

EG(1)