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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02733978

Enrollment

Registered

2016-04-12

Start date

2016-06-30

Completion date

2016-10-31

Last updated

2018-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scleroderma, Ulcer

Keywords

Ozone oxygen, ulcer healing

Brief summary

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.

Interventions

DEVICEthe 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* calcinosis ulcer traumatic ulcer vasculitis

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Ulcer biopsy	4 months	Biopsy from the ulcer edge

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026