Botulinum Toxin in Raynaud's Phenomenon

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: American Society for Surgery of the Hand
• Treatments: Botulinum Toxins

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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