Botulinum Toxin Type A for Cold Intolerance Secondary to Digital Amputations and Replantations: A Pilot Study
NCT ID: NCT04917731
Last Updated: 2022-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
28 participants
INTERVENTIONAL
2021-06-02
2023-06-02
Brief Summary
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Detailed Description
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Primary null hypothesis: Randomized subjects who receive botulinum toxin type A injections for pain associated with cold intolerance will experience similar changes in pain as compared to patients randomized to receive saline injections (control)
• As measured by the Cold Insensitivity and Severity Score (CISS) at one week, four weeks, and twelve weeks
Aim 2: To assess the safety of botulinum toxin type A on treating cold intolerance secondary to digital amputations and replantations
Hypothesis: Injection of botulinum toxin for cold intolerance secondary to digital amputations and replantations is not associated with any adverse reactions
III. SUBJECT SELECTION All adult, English-speaking patients who present with cold intolerance secondary to digital amputation or replantation will be approached and asked to participate in the study.
Inclusion criteria 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 criteria 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
All patients who satisfy the inclusion/exclusion criteria will be eligible for enrollment. Vulnerable populations will be excluded from this study.
IV. SUBJECT ENROLLMENT A total of twenty-eight patients will be enrolled.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Botox
The patients in this arm will receive Botox injection to the digital arteries of all affected digits.
Botulinum toxin type A
Botox injected at digital artery
Placebo
The patients in this arm will receive placebo injection of saline to the digital arteries of all affected digits.
Botulinum toxin type A
Botox injected at digital artery
Interventions
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Botulinum toxin type A
Botox injected at digital artery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
75 Years
ALL
Yes
Sponsors
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Allergan
INDUSTRY
Massachusetts General Hospital
OTHER
Responsible Party
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Jonathan M. Winograd, M.D.
Visiting Surgeon, Associate Professor Harvard Medical School
Principal Investigators
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Jonathan M Winograd, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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MGH
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2020P002873
Identifier Type: -
Identifier Source: org_study_id
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