Back to resultsOzone Therapy in the Treatment of Digital Ulcers in Patients With Systemic Sclerosis
Primary Purpose
Ulcer, Scleroderma
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
the ozone generator device (Human Pro medic, German)
Sponsored by
About this trial
This is an interventional treatment trial for Ulcer focused on measuring Ozone oxygen, ulcer healing
Eligibility Criteria
Inclusion Criteria:
- systemic sclerosis patients with DUs fulfilling ACR/EULAR criteria for diagnosis 2013
Exclusion Criteria:
- calcinosis ulcer traumatic ulcer vasculitis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ozone treated group
non-ozone treated group
Arm Description
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
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
Outcomes
Primary Outcome Measures
scleroderma ulcer healing
Ulcer size measurement in cm
Pain
Using 10 cm scale
Secondary Outcome Measures
Ulcer biopsy
Biopsy from the ulcer edge
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02733978
Brief Title
Ozone Therapy in the Treatment of Digital Ulcers in Patients With Systemic Sclerosis
Official Title
Non-invasive Oxygen-Ozone Therapy in the Treatment of Digital Ulcers in Egyptian Patients With Systemic Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcer, Scleroderma
Keywords
Ozone oxygen, ulcer healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ozone treated group
Arm Type
Experimental
Arm Description
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
Arm Title
non-ozone treated group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Device
Intervention Name(s)
the ozone generator device (Human Pro medic, German)
Intervention Description
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)
Primary Outcome Measure Information:
Title
scleroderma ulcer healing
Description
Ulcer size measurement in cm
Time Frame
4 months
Title
Pain
Description
Using 10 cm scale
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Ulcer biopsy
Description
Biopsy from the ulcer edge
Time Frame
4 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
systemic sclerosis patients with DUs fulfilling ACR/EULAR criteria for diagnosis 2013
Exclusion Criteria:
calcinosis ulcer traumatic ulcer vasculitis
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22470237
Citation
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.
Results Reference
result
Links:
URL
http://dx.doi.org/10.1155/2014/273475
Description
Related Info
Learn more about this trial
Ozone Therapy in the Treatment of Digital Ulcers in Patients With Systemic Sclerosis
We'll reach out to this number within 24 hrs