NCT07050264

Brief Summary

Burn survivors have difficulty thermoregulating due to reduced skin blood flow and sweating responses at the grafted sites. It has been previously shown that this impaired heat dissipation results in burn survivors experiencing higher core temperatures for a given exercise/environmental exposure compared to non-burned individuals. This also holds true with the use of simulated burn injury. When an absorbent material is applied to the skin over a desired amount of body surface area, it replicates a burn injury of the same size (i.e., simulated burn injury). A question that remains unknown is if this impaired thermoregulation in burn survivors would affect post-exercise core temperature recovery, i.e., do burn survivors recover slower than non-burned individuals upon stopping exercise. To that end, the primary objective of this project is to determine the rate at which body temperature and other markers of thermoregulation recover after a bout of exercise in the heat and if this response is different in the same individual with and without simulated burn injury.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
27mo left

Started Mar 2026

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

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Study Timeline

Key milestones and dates

Study Progress8%
Mar 2026Aug 2028

First Submitted

Initial submission to the registry

June 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

2.4 years

First QC Date

June 25, 2025

Last Update Submit

January 23, 2026

Conditions

Burn InjuryBody Temperature RegulationCardiovascular Physiology

Outcome Measures

Primary Outcomes (1)

  • Core Temperature

    From baseline to end of 60 minutes of recovery

Secondary Outcomes (1)

  • Heart Rate

    From baseline to the end of 60 minutes of recovery

Study Arms (4)

Hot and Humid with simulated burns

EXPERIMENTAL

Individuals will be exposed to hot and humid conditions with a simulated burn injury.

Other: Simulated burn injury via application of absorbent and impermeable material over 60% of the body

Hot and Humid without simulated burns

NO INTERVENTION

Individuals will be exposed to hot and humid conditions without a simulated burn injury.

Hot and Dry with simulated burns

EXPERIMENTAL

Individuals will be exposed to hot and dry conditions with a simulated burn injury.

Other: Simulated burn injury via application of absorbent and impermeable material over 60% of the body

Hot and Dry without simulated burns

NO INTERVENTION

Individuals will be exposed to hot and dry conditions without a simulated burn injury.

Interventions

Simulated burn injury via application of absorbent and impermeable material over 60% of the bodyOTHER

Simulated burn injury via application of absorbent and impermeable material over 60% of the body

Hot and Dry with simulated burnsHot and Humid with simulated burns

Eligibility Criteria

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

You may qualify if:

  • and 65 years of age
  • free of any significant underlying medical problems based upon a detailed medical history and physical exam, and normal resting electrocardiogram.

You may not qualify if:

  • Known heart disease
  • other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, and uncontrolled hypertension, etc. as well as serious abnormalities detected on routine screening.
  • Individuals who are pregnant, planning to become pregnant, or breastfeeding will be excluded, this will be confirmed in females using a urine pregnancy test.
  • Taking prescribed medications (such as beta blockers and non-dihydropyridine calcium channel blockers) or over-the-counter medications that have known influences on thermoregulatory response.
  • Current smokers, as well as individuals who regularly smoked within the past 3 years.
  • body mass index is ≥ 31 kg/m2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Exercise and Environmental Medicine - Texas Health Presbyterian Hospital Dallas

Dallas, Texas, 75231, United States

RECRUITING

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Craig G Crandall, PhD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin M Harper, B.S.

CONTACT

12143454737erin.harper2@utsouthwestern.edu

Elizabeth A Gideon, PhD

CONTACT

betsygideon@texashealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Internal Medicine and director of the thermal and vascular physiology lab

Study Record Dates

First Submitted

June 25, 2025

First Posted

July 3, 2025

Study Start

March 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)