Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05125029

Botulinum Toxin in Raynaud's Phenomenon

Led by Emory University · Updated on 2025-02-12

36

Participants Needed

1

Research Sites

198 weeks

Total Duration

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Sponsors

E

Emory University

Lead Sponsor

A

American Society for Surgery of the Hand

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Botulinum Toxin in Raynaud's Phenomenon

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 or older
  • Patients with moderate to severe Raynaud's Phenomenon not controlled after 3 months of standard medical therapy
  • Patients with severe Raynaud's Phenomenon showing evidence of tissue loss
Not Eligible

You will not qualify if you...

  • Patients under 18 years old
  • Previous Botulinum toxin treatment for Raynaud's Phenomenon within the past year
  • Active infection at the treatment site including cellulitis, fever, chills, or elevated inflammatory markers
  • Prior digital sympathectomy surgery for Raynaud's Phenomenon
  • Changes to medical treatment for Raynaud's Phenomenon within the past 4 weeks
  • Allergy or contraindication to Botulinum toxin injection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Emory University Hospital

Atlanta, Georgia, United States, 30322

Actively Recruiting

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Research Team

P

Paul A Ghareeb, MD

CONTACT

A

Anthony Karzon

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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