Phototherapy For Treatment Of Raynaud's Phenomenon

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-31

Study Completion Date

2023-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Raynaud Disease Raynaud Phenomenon Raynaud Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Sham First, then Experimental

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

Group Type EXPERIMENTAL

Blue Light Therapy

Intervention Type 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.

Sham Light Therapy

Intervention Type 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

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

Group Type EXPERIMENTAL

Blue Light Therapy

Intervention Type 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.

Sham Light Therapy

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No