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

NCT04947449 | Terminated FDA Device

• 1 other identifier: STU-2021-0241
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Burn Injury

Keywords

laser treatment; laser therapy; skin blood flow; sweating

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

fractional CO2 laser DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy individuals who undergo laser treatment for burn injuries

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 1, 2021
• Study Start: July 29, 2021
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

US (1)