Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Raynaud's Phenomenon (RP) is the most common vasospastic (i.e. conditions where small blood vessels near the surface of the skin have spasms that limit blood flow) disorder encountered by hand surgeons with an estimated prevalence of 5% in the general population. The clinical manifestations are broad, and can range from minor pain, cold sensitivity and color changes to impaired hand function, intolerable pain and tissue loss/digital ulceration. Treatment algorithms include activity modification and medical therapies. However, refractory RP can warrant surgical intervention, such as peri-arterial sympathectomy, of which has significant associated morbidity. While the exact mechanism is still being elucidated, several retrospective reviews have demonstrated efficacy of BT in the treatment of RP. Specifically, increases in post treatment perfusion have been demonstrated and clinical evidence of improvement in pain scores and tissue loss are reported. However, the literature varies in regard to injection technique (location and dose) and duration of action. The goal of this study is to evaluate the efficacy of BT in the treatment of treatment refractory RP by objective and subjective measures. This study will perform a single-site double-blinded, randomized, placebo-controlled trial evaluating two different doses of BT (10 units and 20 units) injected into each patient's fingers of both hands versus injection of a normal saline control, given that there is currently no widely accepted standard of care for the treatment of BT. Following injection, patients will be evaluated in regular intervals to assess for impact on finger temperature, oxygenation, patient reported outcome measures (PROMs), and effect on tissue loss. The study will take place under Emory University School of Medicine, specifically the Upper Extremity Division. Patients may also be originally seen under the Rheumatology Division and subsequently referred to the Upper Extremity Division for study participation. In total, the study aims to recruit 36 patients. There will be no outside recruitment or advertisement materials. With this research study, the study team seeks to establish a standardized injection technique and dosage for this disease and to determine duration of symptom alleviation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05125029
Study type Interventional
Source Emory University
Contact Paul A Ghareeb, MD
Phone 404-686-8143
Email [email protected]
Status Not yet recruiting
Phase Phase 4
Start date November 2021
Completion date September 2023

See also
  Status Clinical Trial Phase
Withdrawn NCT03393325 - Tadalafil-Delivra and Raynaud's Phenomenon
Recruiting NCT03749577 - Nutritional Strategies to Increase Nitric Oxide Signaling in Raynaud's Phenomenon N/A
Completed NCT03699436 - Effectiveness of Electric Stimulation Therapy in Raynaud's Phenomenon N/A
Recruiting NCT03984422 - Application for Monitoring and Evaluation of Raynaud's Phenomenon
Recruiting NCT04015193 - Follow-up of SPTS in Patients With Raynaud's Phenomenon
Not yet recruiting NCT04898036 - Phototherapy For Treatment Of Raynaud's Phenomenon N/A
Not yet recruiting NCT03972566 - Localized Effects of PBM and Exogenous NO on CREST Patients Calcinosis Cutis & Raynaud Phenomenon
Recruiting NCT04854850 - Apollo Device for Fatigue in Systemic Sclerosis N/A
Completed NCT03129178 - Beet the Cold: The Effect of Inorganic Nitrate Supplementation in Individuals With Raynaud's Phenomenon N/A
Completed NCT04388176 - Cold Challenge With C21 in RP Phase 2
Completed NCT01280266 - Efficacy Study of PDE-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon Phase 2/Phase 3
Completed NCT04644523 - Dermoscopy in Primary Raynaud's Phenomenon
Completed NCT03094910 - Investigation of the Rewarming og the Fingers After Cooling and the Autonomic Nervous System in Raynaud's Phenomenon N/A
Terminated NCT03639766 - The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon Phase 4
Terminated NCT03869008 - Potential Benefit for Non Invasive Vagus Nerve Stimulation Using GammaCore in the Treatment of Raynaud's Phenomena. N/A
Recruiting NCT01347008 - Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis Phase 3