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Clinical Trials/NCT04947449
NCT04947449
Terminated
Not Applicable

Laser Therapy on Burned Skin

University of Texas Southwestern Medical Center1 site in 1 country4 target enrollmentJuly 29, 2021
ConditionsBurn Injury

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Burn Injury
Sponsor
University of Texas Southwestern Medical Center
Enrollment
4
Locations
1
Primary Endpoint
Skin blood flow
Status
Terminated
Last Updated
last year

Overview

Brief Summary

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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
July 29, 2021
End Date
March 1, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Craig Crandall

Professor of Medicine

University of Texas Southwestern Medical Center

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Skin blood flow

Time Frame: Upwards to 6 months after the final laser treatment

Primary outcome variables will be skin blood flow and sweating responses from skin treated with laser therapy and adjacent untreated/uninjured skin.

Study Sites (1)

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