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

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04947449

Collaborator

(none)

Enrollment

Location

35.1

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Burn Injury	Device: fractional CO2 laser

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Laser Therapy on Burned Skin

Actual Study Start Date :

Jul 29, 2021

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Outcome Measures

Primary Outcome Measures

Skin blood flow [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Craig Crandall, Professor of Medicine, University of Texas Southwestern Medical Center

ClinicalTrials.gov Identifier:

NCT04947449

Other Study ID Numbers:

STU-2021-0241

First Posted:

Jul 1, 2021

Last Update Posted:

Aug 2, 2021

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Craig Crandall, Professor of Medicine, University of Texas Southwestern Medical Center

Additional relevant MeSH terms:

Burns

Study Results

No Results Posted as of Aug 2, 2021