Status:
UNKNOWN
Botulinum Toxin Type A for Cold Intolerance Secondary to Digital Amputations and Replantations: A Pilot Study
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Allergan
Conditions:
Cold Intolerance
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
Aim 1: To assess the efficacy of botulinum toxin type A on treating cold intolerance secondary to digital amputations, revascularizations, or replantations Primary null hypothesis: Randomized subject...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 2 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04917731
Start Date
June 2 2021
End Date
June 2 2023
Last Update
August 24 2022
Active Locations (1)
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1
MGH
Boston, Massachusetts, United States, 02114