Actively Recruiting
Double Blind Randomized Controlled Trial to Evaluate Botulinum Toxin Injection Effects in Raynaud's Phenomenon
Led by Emory University · Updated on 2025-02-12
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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 a common condition where small blood vessels in the skin have spasms that reduce blood flow. It affects about 5% of the population and can cause symptoms ranging from mild pain and color changes to severe pain, impaired hand function, and tissue damage. This research aims to assess the effects of Botulinum toxin (BT) in patients with RP that does not respond to standard treatments, using both objective and patient-reported measures. The study is a double-blinded, randomized, placebo-controlled trial conducted at a single site. Participants will be randomly assigned to receive injections in their finger bases of either a placebo, 10 units of BT per digit, or 20 units of BT per digit. Before injection, patients rest in a temperature-controlled room to normalize finger temperature. The injections are administered by hand surgeons using a standardized technique to ensure safety and accurate placement. Participants will be evaluated over 24 weeks following injection. Measurements will include finger temperature and tissue oxygen levels at baseline, 4, 12, and 24 weeks. Patient-reported outcomes will assess pain, hand function, and Raynaud's symptoms through questionnaires conducted in person and by phone. The study aims to establish a standard BT injection method and dosage, monitoring changes in symptoms and tissue health throughout the study period.
CONDITIONS
Brief Title
Botulinum Toxin in Raynaud's Phenomenon
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Moderate to severe Raynaud's Phenomenon not controlled after 3 months of standard medical therapy prescribed by a Rheumatologist
- Severe Raynaud's Phenomenon with evidence of tissue loss
You will not qualify if you...
- Age under 18 years
- Botulinum toxin treatment for Raynaud's Phenomenon within the past year
- Active infection at the treatment site (such as cellulitis, pus, fever, chills, or elevated inflammatory markers)
- Prior digital sympathectomy surgery for Raynaud's Phenomenon
- Recent changes in 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single injection with follow-up to 24 weeks
Participants receive injections of Botulinum toxin or placebo into the base of each finger to evaluate the effect on Raynaud's Phenomenon symptoms.
1 injection visit (in-person)
Duration - 24 weeks post injection
Participants are evaluated regularly to assess finger temperature, tissue oxygenation, pain, and hand function over 24 weeks post-injection.
Visits at 4 weeks and 12 weeks (in-person), telephone interviews at 16 and 20 weeks, and a final visit at 24 weeks (in-person)
Trial Site Locations
Total: 1 location
1
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
P
Paul A Ghareeb, MD
A
Anthony Karzon
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Frequently Asked Questions
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