Calcinosis Cutis in Connective Tissue DiseasePhase 3NCT01683500
Calcinosis Cutis: Therapeutic Effects of Extracorporeal Shock Wave Therapy (ESWT)
A Phase 3 study testing shock wave therapy with Modulith SLK (Storz) in people with Calcinosis Cutis in Connective Tissue Disease, run by University of Zurich at 1 site in Switzerland.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calcinosis Cutis in Connective Tissue Disease
- What is being tested?
- shock wave therapy with Modulith SLK (Storz)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2012to Aug 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18
- Calcinosis cutis due to connective tissue disease
- information about ESWT given
- Patient understands the study and signs the informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Rheumatology
Zurich, Canton of Zurich, 8091
About this study
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
Read the 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.
- Being tested
- shock wave therapy with Modulith SLK (Storz)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shock wave therapy with Modulith SLK (Storz)Device
Three sessions with shock wave therapy, interval of one week.
| Study group | Role | What they receive |
|---|---|---|
| shock wave therapy | Experimental | intervention: shock wave therapy with Modulith SLK (Storz) Receives: Device: shock wave therapy with Modulith SLK (Storz) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pain
Measured: after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcinosis Cutis in Connective Tissue DiseaseStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra Blumhardt, MD, Principal investigator, University Hospital Zurich, Division of Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683500
- Sponsor's protocol ID
- CCESWT01
- Status last verified
- May 2015
- First submitted
- 7 Sep 2012
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcinosis Cutis: Therapeutic Effects of Extracorporeal Shock Wave Therapy (ESWT)
- ClinicalTrials.gov ID
- NCT01683500
- Acronym / sponsor ID
- CCESWT01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 11 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| shock wave therapy | Experimental | Device: shock wave therapy with Modulith SLK (Storz)intervention: shock wave therapy with Modulith SLK (Storz) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age of 18
- Calcinosis cutis due to connective tissue disease
- information about ESWT given
- Patient understands the study and signs the informed consent
Key exclusion criteria (8 listed)
- No ESWT done
- cuagulopathy
- sepsis
- pregnancy
- pace maker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shock wave therapy with Modulith SLK (Storz)Three sessions with shock wave therapy, interval of one week. | Device | shock wave therapy |
Primary outcome
change in pain
Time frame: after 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
Related trials for Calcinosis Cutis in Connective Tissue Disease
RecruitingObservational study
Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images
Systemic Sclerosis (SSc), Calcinosis Cutis
Not yet recruitingObservational study
Tissue Validation of Mammographic Breast Arterial Calcification in Mastectomy Specimens
Breast Cancer, Vascular Calcification
Active, not recruiting
Searching for Masses and Calcifications at the Same Time in Breast Cancer Screening
Mammography, Breast Cancer
Active, not recruitingObservational study
MRI Characterization of Mammographically Detected DCIS
Breast Cancer, Stage 0
Recruiting
Multicenter Cardiac Decision Impact Study in People With Breast Cancer
Breast Cancer, Cardiovascular (CV) Risk
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Blumhardt, MD principal investigator
University Hospital Zurich, Division of Rheumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing shock wave therapy with Modulith SLK (Storz) in people with Calcinosis Cutis in Connective Tissue Disease, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in pain (time frame: after 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.