Using sodium thiosulfate injections to treat ectopic calcifications and ossifications

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study investigates the use of subcutaneous sodium thiosulfate injections to treat ectopic calcifications and ossifications associated with conditions like systemic sclerosis, dermatomyositis, and iPPSD2. The study aims to assess the efficacy of sodium thiosulfate, which is traditionally used for cyanide poisoning, in alleviating pain and improving quality of life for patients suffering from these rare complications. Participants will be monitored for significant morbidity and functional impact related to their calcifications or ossifications, with a focus on those who are not candidates for surgical intervention. The study will include patients aged 2 years and older who meet specific inclusion criteria and have provided informed consent.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient presenting with:

  * ectopic ossification secondary to iPPSD2 or
  * ectopic calcification secondary to dermatomyositis or
  * ectopic calcification secondary to systemic sclerosis
* Patient aged 2 years or over
* Indication of STS infusion validated by a multidisciplinary committee, based on the significant morbidity and/or functional impact of the targeted calcification/ossification
* Patient with no planned surgery of the calcifications/ossifications for the twelve coming months
* Women of childbearing potential on highly effective contraception (such as hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence)
* Men with women of childbearing potential partners should use condoms during the whole treatment period and until 91 days after the last injection.
* Informed consent signed by the patient / parents
* Patient affiliated to the social security system

Exclusion Criteria:

* Allergy to STS or one of the excipients used
* Contraindication to local injection of STS
* Anticoagulant therapy
* Pregnant, parturient or breastfeeding woman
* Patient deprived of freedom by a court judgment or an administrative decision
* Patient undergoing psychiatric care under coercion
* Legally protected adult patients (guardianship / curatorship)
* Patient unable to give consent
* Patient placed under judicial protection

Where it's running

• CHU de BORDEAUX
  Bordeaux, France Recruiting
• Hospice Civil de Lyon
  Bron, France Recruiting
• ApHp - Hôpital Bicêtre
  Le Kremlin-Bicêtre, France Recruiting
• CHU de Limoges
  Limoges, France Recruiting
• ApHp - hôpital Lariboisière
  Paris, France Recruiting
• Hôpital Cochin
  Paris, France Recruiting

Study contacts

• Principal investigator: Vincent GUIGONIS, MD — University Hospital, Limoges
• Study coordinator: Vincent GUIGONIS, MD
• Email: vincent.guigonis@unilim.fr
• Phone: 555056358

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.