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NCT04947449 Clinical Trial

Potential Benefits of Laser Treatment on Skin Blood Flow and Sweating in Burn Survivors

Burn Injury Clinical Trial

Official title:
Laser Therapy on Burned Skin

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04947449
Other study ID # STU-2021-0241
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 29, 2021
Est. completion date June 30, 2024

Study information
Verified date August 2023
Source University of Texas Southwestern Medical Center
Contact whitley Atkins, PhD
Phone 214-345-4623
Email whitleyatkins@texashealth.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to examine effects of laser therapy on blood flow and sweating responses in burn-injured skin.

Description:

This is a longitudinal study in which the effects of laser therapy on cutaneous vascular responses and sweating of the treated areas are assessed. Specifically, burn survivors who will undergo standard of care laser therapy to treat burn-related scars will perform whole-body heating and local heating procedures prior to the initiation of laser therapy, at an intermediate point during the laser therapy regimen, and upon conclusion of the laser therapy regimen. For this pilot investigation a placebo will not be incorporated. Primary outcome variables will be skin blood flow and sweating responses from skin treated with laser therapy and adjacent untreated/uninjured skin.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 18-65 years old - Experience a severe burn injury that warrant laser therapy. - Free of any significant underlying medical problems based upon a detailed medical history and physical exam Exclusion Criteria: - Known heart disease - Other chronic medical conditions requiring regular medical therapy including cancer, diabetes, uncontrolled hypertension, and uncontrolled hypercholesterolemia. - Abnormality detected on routine screening suggestive of cardiac ischemia or previously undetected cardiac disease or resting left bundle branch block on screening electrocardiogram. - Subject with a body mass index >35 kg/m2 - Pregnant or planning to become pregnant within the subsequent 6 months.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• fractional CO2 laser
Standard of care laser treatment of burn-related injuries will be performed. This protocol assesses the effects of those treatments on skin blood flow and sweating responses.

Locations
Country Name City State
United States University of Texas Southwestern Medical Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Skin blood flow Primary outcome variables will be skin blood flow and sweating responses from skin treated with laser therapy and adjacent untreated/uninjured skin. Upwards to 6 months after the final laser treatment
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