- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01683500
Calcinosis Cutis: Therapeutic Effects of Extracorporeal Shock Wave Therapy (ESWT)
June 2, 2015 updated by: University of Zurich
Patients with calcinosis cutis due to connective tissue disease get a shock wave therapy. The shock wave therapy will be done in 3 sessions with one week interval. The outcome parameters are: change in pain, size of the calcinosis, of possible ulcers and intake of painkillers.
- Trial with medical device
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Patients with calcinosis cutis due to connective tissue disease get a shock wave therapy (medical device).
The shock wave therapy will be done in 3 sessions with one week interval.
The outcome parameters are: change in pain (questionnaire), size of the calcinosis (ultrasound and CT), new ulcers and intake of painkillers.
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
ZH
-
Zurich, ZH, Switzerland, 8091
- University Hospital Zurich, Division of Rheumatology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Age of 18
- Calcinosis cutis due to connective tissue disease
- information about ESWT given
- Patient understands the study and signs the informed consent
Exclusion criteria:
- No ESWT done
- cuagulopathy
- sepsis
- pregnancy
- pace maker
- severe disease in the opinion of the investigator
- cardiac risk with NYHA III-IV
- Ehlers-Danlos-Syndrome
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: shock wave therapy
intervention: shock wave therapy with Modulith SLK (Storz)
|
Three sessions with shock wave therapy, interval of one week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in pain
Time Frame: after 6 weeks
|
after 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sandra Blumhardt, MD, University Hospital Zurich, Division of Rheumatology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
September 7, 2012
First Submitted That Met QC Criteria
September 7, 2012
First Posted (Estimate)
September 11, 2012
Study Record Updates
Last Update Posted (Estimate)
June 3, 2015
Last Update Submitted That Met QC Criteria
June 2, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCESWT01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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