Ozone Therapy in the Treatment of Digital Ulcers in Patients With Systemic Sclerosis

February 16, 2018 updated by: Manal Hassanien, Assiut University

Non-invasive Oxygen-Ozone Therapy in the Treatment of Digital Ulcers in Egyptian Patients With Systemic Sclerosis

Digital ulcers (DUs) in scleroderma result from recurrent Raynaud's phenomenon (RP) and microtrauma with high impact on quality of life, management of DUs is a great challenge for clinicians. Medical use of ozone (triatomic oxygen) was initiated in the 19th century. Ozone has multiple therapeutic effects in wound healing due to the property of releasing nascent oxygen, which has been shown to stimulate antioxidant enzymes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Digital ulcers (DUs) in scleroderma result from recurrent Raynaud's phenomenon (RP) and microtrauma with high impact on quality of life, management of DUs is a great challenge for clinicians. Medical use of ozone (triatomic oxygen) was initiated in the 19th century. Ozone has multiple therapeutic effects in wound healing due to the property of releasing nascent oxygen, which has been shown to stimulate antioxidant enzymes, we aim to assess the effects of ozone therapy on the healing in Scleroderma DUs and the expressions of vascular endothelial growth factor (VEGF), and endothelin-1 type A receptor (ETAR) and angiotensin II type 1 receptor (AT1R) autoantibodies level in the wounds after treatment.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • systemic sclerosis patients with DUs fulfilling ACR/EULAR criteria for diagnosis 2013

Exclusion Criteria:

  • calcinosis ulcer traumatic ulcer vasculitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ozone treated group
Therapeutic effects will be graded into 4 levels from grade 0 (no change) to grade 3 (wound healing). The wound sizes will be measured at baseline and day 20, respectively. Tissue biopsies will be performed at baseline and day 20, expressions of VEGF, ETAR and AT1R autoantibodies proteins will be determined by immune-histochemical examinations
Device: the ozone generator device (Human Pro medic, German)
noninvasive oxygen-ozone treatments with 52 ug/mL ozone (total volume: 20-50 mL) in a special bag for 30 min per day for 20 days using the ozone generator device (Human Pro Medic, German)
No Intervention: non-ozone treated group
Therapeutic effects will be graded into 4 levels from grade 0 (no change) to grade 3 (wound healing). The wound sizes will be measured at baseline and day 20, respectively. Tissue biopsies will be performed at baseline and day 20, expressions of VEGF, ETAR and AT1R autoantibodies proteins will be determined by immune-histochemical examinations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
scleroderma ulcer healing
Time Frame: 4 months
Ulcer size measurement in cm
4 months
Pain
Time Frame: 4 months
Using 10 cm scale
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ulcer biopsy
Time Frame: 4 months
Biopsy from the ulcer edge
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

March 25, 2016

First Submitted That Met QC Criteria

April 6, 2016

First Posted (Estimate)

April 12, 2016

Study Record Updates

Last Update Posted (Actual)

February 20, 2018

Last Update Submitted That Met QC Criteria

February 16, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Assuit Ozone

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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