Phototherapy For Treatment Of Raynaud's Phenomenon

Raynaud Phenomenon Clinical Trial

Official title:

Phototherapy For Treatment Of Raynaud's Phenomenon

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04898036
• Other study ID #: RHEUM-2021-29567
• Status: Withdrawn
• Phase: N/A
• Start date: August 2022
• Est. completion date: March 2023

Study information

• Verified date: January 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine if blue light therapy can improve the symptoms of Raynaud's phenomenon, and provide parameters for ultimately designing commercial treatment devices, an investigational stationary phototherapy unit was designed and built.

Description:

The purpose of this study is to test the efficacy of blue light phototherapy for the treatment of Raynaud's phenomenon (RP) in human participants. The specific aim is to see if phototherapy treatment applied to the hands will reduce the symptoms that RP participants experience. This will be measured through the use of a visual analog scale (VAS) of both pain and numbness. This study will also help to infer whether blue light phototherapy causes vasodilation through infrared thermal imaging of the hands and continuous measurement of skin temperature with a surface thermistor. Together, the visual analog scale (VAS) and infrared thermal imaging contribute to the objective of deducing whether blue light phototherapy can lead to reduced RP symptoms due to vasodilation of blood vessels.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Must have a current diagnosis by a physician of Raynaud's Phenomenon/Syndrome

Exclusion Criteria:

• Those with active ischemic digital ulcers or gangrene as the cold exposure can be a safety hazard for them.
• Inability of the subject to place their hands into the PTD portal because of physical size or discomfort.
• Inability of the subject to wear protective eyewear.
• Anyone, who in the judgement of any of the investigators, would be unable to safely complete the study procedures.
• Females who are pregnant.
• Adults unable to consent for any reason not explicitly stated herein.

Related Conditions & MeSH terms

• Raynaud Disease
• Raynaud Phenomenon
• Raynaud Syndrome

Intervention

Device:
• Blue Light Therapy
This phototherapy device (PTD-1) consists of a Plexiglas hand compartment (cleanable) enclosed in a powder-coated steel cabinet. Within the cabinet are two blue LED panels located above and below the hand compartment to illuminate the hands.
• Sham Light Therapy
To turn the device into a sham mode, a thin opaque liner can be inserted which will block light from illuminating the hands.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Thermal Imaging	The thermal imaging camera takes still images of the hand before and immediately after treatment. It provides a heat map (color contour) that may be probed afterwards for temperature at designated points. These points are distributed over the fingers, hand and palms. A technician manually reads the temperature in degrees Celsius and enters the values into an Excel spreadsheet designating subject, ID and date; location of measurement; and other temperature readings. These include ambient (room temperature), and outside temperature. The finger and room temperatures, in Celsius, are electronically recorded on an Omega data logger. This is interrogated later to retrieve data. Another continuous reading is obtained of the temperature inside the hand compartment (separate from internal thermoregulation measurements) to track equipment functionality.	4 hours
Primary	Change in Visual Analog Scale (VAS) of Pain	Participants will be asked to rate their pain upon cold room exposure between treatments using a 10 centimeter visual analog scale (VAS). Outcome is reported as the mean change in VAS per arm in units of millimeters.	4 hours
Primary	Change in Visual Analog Scale (VAS) of Numbness	Participants will be asked to rate their numbness upon cold room exposure between treatments using a 10 centimeter visual analog scale (VAS). Outcome is reported as the mean change in VAS per arm in units of millimeters.	4 hours
Secondary	Skin Temperature	Skin temperature of at least one finger will be measured and logged using a thermometer at multiple points during study visit. Outcome is reported in units of degrees Celsius.	4 hours