RECRUITING

Botulinum Toxin in Raynaud's Phenomenon

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Conditions

Raynaud PhenomenonBotulinum toxinRaynaud Phenomenon refractory to treatment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Double Blind RCT to Evaluate the Effect of Botulinum Toxin in Raynaud Phenomenon

Quick Facts

Study Start:2022-02-10
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05125029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 or older
  2. * 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.
  1. * Patients under the age of 18
  2. * Patients who have previously undergone treatment with BT for RP within the past year
  3. * 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)
  4. * Patients who have undergone prior digital sympathectomy surgery for RP
  5. * Patients who have recently altered their medical regimen for RP within the past 4 weeks
  6. * Patients with allergy or contraindication to BT injection

Contacts and Locations

Study Contact

Paul A Ghareeb, MD
CONTACT
404-686-8143
paul.ghareeb@emory.edu
Anthony Karzon
CONTACT
akarzon@emory.edu

Principal Investigator

Paul A Ghareeb, MD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Emory University Hospital
Atlanta, Georgia, 30322
United States

Collaborators and Investigators

Sponsor: Emory University

  • Paul A Ghareeb, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-10
Study Completion Date2024-12

Study Record Updates

Study Start Date2022-02-10
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • Botulinum toxin
  • Raynaud Phenomenon refractory to treatment

Additional Relevant MeSH Terms

  • Raynaud Phenomenon