Botulinum Toxin in Raynaud's Phenomenon
Double Blind RCT to Evaluate the Effect of Botulinum Toxin in Raynaud Phenomenon
Emory University
36 participants
Feb 10, 2022
INTERVENTIONAL
Conditions
Summary
Raynaud's Phenomenon (RP) is the most common vasospastic disorder encountered by hand surgeons with an estimated prevalence of 5% in the general population. It's manifestations are broad, and can range from minor to severe. Sometimes it can be refractory to treatments. The goal of this study is to evaluate the efficacy of Botulinum toxin (BT) in the treatment of treatment refractory RP by objective and subjective measures.
Eligibility
Inclusion Criteria2
- Age 18 or older
- Patients with moderate to severe RP that is not controlled after 3 months of standard medical therapy as prescribed by a Rheumatologist, or severe RP with evidence of tissue loss.
Exclusion Criteria6
- Patients under the age of 18
- Patients who have previously undergone treatment with BT for RP within the past year
- Patients with active infection at the treatment site (active infection defined as cellulitis, purulence, fever, chills, or presence of elevated inflammatory markers, ie. WBC, ESR, CRP)
- Patients who have undergone prior digital sympathectomy surgery for RP
- Patients who have recently altered their medical regimen for RP within the past 4 weeks
- Patients with allergy or contraindication to BT injection
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Interventions
Botulinum toxin is a neurotoxic protein produced by the bacterium Clostridium botulinum that prevents the release of the neurotransmitter acetylcholine from the neuromuscular junction, thereby preventing muscular contraction. Eligible subjects will be randomized 1:1:1 into three different groups: 1) placebo 2) 10 Units of BT injected per digit and 3) 20 units of BT injected per digit.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05125029