NCT06529757

Brief Summary

This project will identify the efficacy of whole body skin wetting aimed to attenuate excessive elevations in internal body temperatures during physical activity in well-healed burn survivors. The investigators will conduct a randomized crossover design study. Non-burned control subjects, subjects who experienced burns covering \~20% to 40% of their body surface area, and subject having burns \>40% of their body surface area will be investigated. Subjects will exercise in heated environmental conditions while receiving no cooling or whole body skin wetting.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jul 2024Jul 2026

First Submitted

Initial submission to the registry

July 26, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

July 31, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

October 21, 2025

Status Verified

October 1, 2025

Enrollment Period

2 years

First QC Date

July 26, 2024

Last Update Submit

October 20, 2025

Conditions

Burn Injury

Outcome Measures

Primary Outcomes (1)

  • Core Temperature

    During exercise, one's core body temperature will increase. This device will measure this increase in core body temperature throughout the exercise.

    Prior to and throughout the bout of exercise; an average of 90 minutes.

Secondary Outcomes (3)

  • Mean Skin Temperature

    Prior to and throughout the bout of exercise; an average of 90 minutes.

  • Rate Pressure Product

    Prior to and throughout the bout of exercise; an average of 90 minutes.

  • Whole body sweat rate

    Before and after exercise. 2 min per measure.

Study Arms (2)

Hot and Dry Environment_no cooling

EXPERIMENTAL

Subjects will exercise for 60 minutes in a hot and dry environment while being exposed to no cooling.

Other: Non-cooling

Hot and Dry Environment_whole body skin wetting

EXPERIMENTAL

Subjects will exercise for 60 minutes in a hot and dry environment while being exposed to whole body skin wetting.

Other: Whole body cooling

Interventions

Whole body coolingOTHER

Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to whole body skin wetting. Skin wetting will be performed by spraying water onto the whole body throughout the exercise bout.

Hot and Dry Environment_whole body skin wetting
Non-coolingOTHER

Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to no cooling modalities.

Hot and Dry Environment_no cooling

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male and female subjects
  • years of age.
  • Free of any underlying medical conditions

You may not qualify if:

  • Any burn-related injuries resulting in at least one night of hospitalization.
  • Heart disease or any other chronic medical condition requiring regular medical therapy including cancer, diabetes, and hypertension.
  • Abnormalities detected on routine screening
  • Individuals who participate in a structured aerobic exercise training program at moderate to high intensities.
  • Current smokers, as well as individuals who regularly smoked within the past 3 years.
  • Body mass index of greater than 30 kg/m\^2.
  • Pregnant individuals
  • Healthy male and female subjects
  • years of age.
  • Free of any underlying medical conditions
  • Having a burn injury covering 20-40% or \>40% of the participant's body surface area; at least 50% of those burn injuries must be full thickness that required skin grafting.
  • Participants must have been hospitalized due to the burn injury for a minimum of 15 days
  • Any burn-related injuries resulting in at least one night of hospitalization.
  • Heart disease or any other chronic medical condition requiring regular medical therapy including cancer, diabetes, and hypertension.
  • Abnormalities detected on routine screening
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Exercise and Environmental Medicine

Dallas, Texas, 75231, United States

RECRUITING

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Craig Crandall, PhD

CONTACT

214-345-4623craigcrandall@texashealth.org

Erin Harper, BS

CONTACT

214-345-4737ErinHarper@texashealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 26, 2024

First Posted

July 31, 2024

Study Start

July 31, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

October 21, 2025

Record last verified: 2025-10

Locations

US(1)