Ozone Therapy in the Treatment of Digital Ulcers in Patients With Systemic Sclerosis
Non-invasive Oxygen-Ozone Therapy in the Treatment of Digital Ulcers in Egyptian Patients With Systemic Sclerosis
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2016
Shorter than P25 for not_applicable
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
March 25, 2016
CompletedFirst Posted
Study publicly available on registry
April 12, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedFebruary 20, 2018
February 1, 2018
2 months
March 25, 2016
February 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
scleroderma ulcer healing
Ulcer size measurement in cm
4 months
Pain
Using 10 cm scale
4 months
Secondary Outcomes (1)
Ulcer biopsy
4 months
Study Arms (2)
ozone treated group
EXPERIMENTALTherapeutic 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
non-ozone treated group
NO INTERVENTIONTherapeutic 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
Interventions
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)
Eligibility Criteria
You may qualify if:
- systemic sclerosis patients with DUs fulfilling ACR/EULAR criteria for diagnosis 2013
You may not qualify if:
- calcinosis ulcer traumatic ulcer vasculitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Elvis AM, Ekta JS. Ozone therapy: A clinical review. J Nat Sci Biol Med. 2011 Jan;2(1):66-70. doi: 10.4103/0976-9668.82319.
PMID: 22470237RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
March 25, 2016
First Posted
April 12, 2016
Study Start
June 1, 2016
Primary Completion
August 1, 2016
Study Completion
October 1, 2016
Last Updated
February 20, 2018
Record last verified: 2018-02