RecruitingPhase 4

Botulinum Toxin in Raynaud's Phenomenon

United States36 participantsStarted 2022-02-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in finger temperature measure

Timeframe: Baseline, 4 weeks, 12 weeks, 24 weeks post injection

Change in tissue Oximetry measure for each finger

Timeframe: Baseline, 4 weeks, 12 weeks, 24 weeks post injection

Trial details

NCT IDNCT05125029

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Paul A Ghareeb, MD

404-686-8143 paul.ghareeb@emory.edu

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