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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02733978
Other study ID # Assuit Ozone
Secondary ID
Status Completed
Phase N/A
First received March 25, 2016
Last updated February 16, 2018
Start date June 2016
Est. completion date October 2016

Study information

Verified date February 2018
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- calcinosis ulcer traumatic ulcer vasculitis

Study Design


Intervention

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)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary scleroderma ulcer healing Ulcer size measurement in cm 4 months
Primary Pain Using 10 cm scale 4 months
Secondary Ulcer biopsy Biopsy from the ulcer edge 4 months
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