Botulinum Toxin Type A for Cold Intolerance Secondary to Digital Amputations and Replantations: A Pilot Study
Status unconfirmed · Phase 1 · Has a placebo group
Conditions studied: Cold Intolerance
In brief
Patients will be selected for cold intolerance after finger amputation or replantation. They will be given Botox or placebo dose as treatment and assessed over 3 months.
Key facts
- Study ID
- NCT04917731
- Run by
- Massachusetts General Hospital
- People needed
- 28
- Starts
- 2021-06-02
- Expected to finish
- 2023-06-02
- Last updated by the study team
- 2022-08-24
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Adults (≥18 years) diagnosed with cold intolerance secondary to digital amputations, revascularizations, or replantations and a CISS score of 30 or higher (the threshold for pathological cold intolerance)11 Ability to give informed consent
You may not qualify if…
- Adults ≥ 75 years old Inability or unwillingness to participate in CISS or DASH survey Major medical comorbidity expected to worsen in the next 6 months Comorbid chronic pain condition Severe and untreated mental health conditions or active substance dependence Pregnant or breastfeeding Known hypersensitivity to botulinum toxin Patients with a compromised respiratory function Pre-existing neuromuscular disorders Receiving therapy with aminoglycosides, anticholinergic agents, and muscle relaxants Infection in the proposed injection site
Where it is running
- MGH — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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