Back to resultsCalcinosis Cutis: Therapeutic Effects of Extracorporeal Shock Wave Therapy (ESWT)
Primary Purpose
Calcinosis Cutis in Connective Tissue Disease
Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
shock wave therapy with Modulith SLK (Storz)
Sponsored by
About this trial
This is an interventional treatment trial for Calcinosis Cutis in Connective Tissue Disease
Eligibility Criteria
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
Sites / Locations
- University Hospital Zurich, Division of Rheumatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
shock wave therapy
Arm Description
intervention: shock wave therapy with Modulith SLK (Storz)
Outcomes
Primary Outcome Measures
change in pain
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01683500
Brief Title
Calcinosis Cutis: Therapeutic Effects of Extracorporeal Shock Wave Therapy (ESWT)
Official Title
Calcinosis Cutis: Therapeutic Effects of Extracorporeal Shock Wave Therapy (ESWT)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcinosis Cutis in Connective Tissue Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
shock wave therapy
Arm Type
Experimental
Arm Description
intervention: shock wave therapy with Modulith SLK (Storz)
Intervention Type
Device
Intervention Name(s)
shock wave therapy with Modulith SLK (Storz)
Intervention Description
Three sessions with shock wave therapy, interval of one week.
Primary Outcome Measure Information:
Title
change in pain
Time Frame
after 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Blumhardt, MD
Organizational Affiliation
University Hospital Zurich, Division of Rheumatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Division of Rheumatology
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Calcinosis Cutis: Therapeutic Effects of Extracorporeal Shock Wave Therapy (ESWT)
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