Phototherapy For Treatment Of Raynaud's Phenomenon

NCT04898036 | Withdrawn FDA Device

• 1 other identifier: RHEUM-2021-29567
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Raynaud Disease; Raynaud Phenomenon; Raynaud Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Skin Temperature

  4 hours

Other Outcomes (1)

• Thermal Imaging

  4 hours

Study Arms (2)

Sham First, then Experimental

EXPERIMENTAL

Participants in this group will receive the sham treatment first, then the experimental treatment.

Device: Blue Light Therapy; Device: Sham Light Therapy

Experimental First, then Sham

EXPERIMENTAL

Participants in this group will receive the experimental treatment first, then the sham treatment.

Device: Blue Light Therapy; Device: Sham Light Therapy

Interventions

Blue Light Therapy DEVICE

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.

Experimental First, then Sham; Sham First, then Experimental

Sham Light Therapy DEVICE

To turn the device into a sham mode, a thin opaque liner can be inserted which will block light from illuminating the hands.

Experimental First, then Sham; Sham First, then Experimental

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Raynaud Disease

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jerry Molitor, MD, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 24, 2021
• Study Start: August 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: January 6, 2023

Record last verified: 2023-01

Locations

US (1)