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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ulcer Scleroderma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

the ozone generator device (Human Pro medic, German)

Intervention Type DEVICE

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)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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)

Intervention Type DEVICE