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

NCT02733978 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-02-20

No results posted yet for this study

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.

Conditions

  • Ulcer
  • Scleroderma

Interventions

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)

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-08-31
Completion
2016-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02733978 on ClinicalTrials.gov