Trial · NCT03582800
Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study
NCT03582800, Phase 2, Recruiting, University Hospital, Limoges
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study. Trials, record NCT03582800. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03582800
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study
- NCT number
- NCT03582800
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 40 participants, estimated
- Lead sponsor
- University Hospital, Limoges
- Conditions
- Systemic Sclerosis, Dermatomyositis, iPPSD2
- Interventions
- STS
- First posted
- 2018-07-11
- Last updated
- 2026-09-15
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of the percentage of volume of the treated calcifications / ossifications | between Month 6 and Month 12 | Calculation of percentage of volume evolution of the treated calcification / ossification between the beginning and the end of STS treatment, in each of the three diseases (dermatomyositis, systemic sclerosis and iPPSD2), evaluated on CT-scan measurements. |
| Secondary | Change of the volume of the treated calcifications / ossifications | Month 0, Month 6 and Month 12 | Calculation of volume of the treated calcification / ossification at (i) inclusion, the end of the run-in period (6 month) and after 6 months of local injections of STS in each disease (12 month), evaluated on CT-scan measurements. |
| Secondary | Adverse events | Month 12 | Collection of adverse events (clinical and biological): causality, severity, and seriousness during the STS treatment. |
| Secondary | Change of the Hounsfield density of the treated ectopic calcifications/ossifications | Month 0, Month 6 and Month 12 | Hounsfield density analysis of the treated ectopic calcifications/ossifications at inclusion, the end of the run-in period (6 month) and after 6 months of local injections of STS (12 month), evaluated on CT-scan measurements. |
| Secondary | Change of the percentage of patient with a clinically pertinent variation in pain | Between Month0 and Month 6 and Between Month 6 and Month 12 | Calculation of Percentage of patients with a clinically pertinent variation in pain evaluated with pain scales: difference in hetero-evaluation scale of pain in children (HEDEN) ≥ 2 (2-7 years old) between M0-M6 and M6-M12 |
| Secondary | Change of the percentage of patient with a clinically pertinent variation in pain | Between Month0 and Month 6 and Between Month 6 and Month 12 | Calculation of Percentage of patients with a clinically pertinent variation in pain evaluated with pain scales: difference in visual analogue pain intensity scale (VAS) score ≥ 2 (\> 7 years old) between M0-M6 and M6-M12 |
| Secondary | Change of the percentage of patients with a clinically pertinent variation in quality of life | Between Month0 and Month 6 and Between Month 6 and Month 12 | Calculation of percentage of patients with a clinically pertinent variation in quality of life : difference in PedsQL ≥ 5 (2-18 years old, using appropriates reports) between M0-M6 and M6-M12 |
| Secondary | Change of the percentage of patients with a clinically pertinent variation in quality of life | Between Month0 and Month 6 and Between Month 6 and Month 12 | Calculation of percentage of patients with a clinically pertinent variation in quality of life : difference in Short Form 36 (SF36) score ≥ 20 (\> 18 years old) between M0-M6 and M6-M12 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03582800
GET https://conductscience.org/api/trials/v1/NCT03582800/registered