Potential Benefits of Laser Treatment on Skin Blood Flow... | NCT04947449

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

NCT04947449

Sponsor

University of Texas Southwestern Medical Center

Status

Terminated

Last Update Posted

Mar 7, 2025Actual

Enrollment

4Actual

Phase

Not provided

Conditions

Burn Injury

Interventions

fractional CO2 laser

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment and retention challenges, coupled with our focus changing to a different direction.

Expanded Access Info

Start Date

Jul 29, 2021Actual

Primary Completion Date

Mar 1, 2025Actual

Completion Date

Mar 1, 2025Actual

First Submitted Date

Jun 23, 2021

First Submission Date that Met QC Criteria

Jun 23, 2021

First Posted Date

Jul 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2025

Last Update Posted Date

Mar 7, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Craig Crandall, Professor of Medicine, University of Texas Southwestern Medical CenterPrincipal Investigator

Lead Sponsor

University of Texas Southwestern Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy individuals who undergo laser treatment for burn injuries

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas Southwestern Medical Center		Dallas	Texas	75390	United States