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

Study Overview
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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.

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.

Official Title
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Non-invasive Oxygen-Ozone Therapy in the Treatment of Digital Ulcers in Egyptian Patients With Systemic Sclerosis

Conditions
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Ulcer, Scleroderma

Intervention / Treatment
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* Device: the ozone generator device (Human Pro medic, German)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: systemic sclerosis patients with DUs fulfilling ACR/EULAR criteria for diagnosis 2013 Exclusion Criteria: calcinosis ulcer traumatic ulcer vasculitis
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ozone treated group<br>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 | Device: the ozone generator device (Human Pro medic, German)<br>* 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)<br>|
| No Intervention: non-ozone treated group<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scleroderma ulcer healing | Ulcer size measurement in cm | 4 months | 
| Pain | Using 10 cm scale | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulcer biopsy | Biopsy from the ulcer edge | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ozone oxygen, ulcer healing