Burn InjuryHSRNCT07050264
The Effect of Simulated Burn Injury on Post Exercise Recovery in Hot Environments
A study testing Simulated burn injury via application of absorbent and impermeable material over 60% of the body in people with Burn Injury and Body Temperature Regulation, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Burn Injury, Body Temperature Regulation, Cardiovascular Physiology
- What is being tested?
- Simulated burn injury via application of absorbent and impermeable material over 60% of the body
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elizabeth A Gideon, PhD contact
United States1 site, 1 recruiting
- Recruiting
Institute for Exercise and Environmental Medicine - Texas Health Presbyterian Hospital Dallas
Dallas, Texas, 75231
Erin M Harper, B.S., 214-345-4737, erin.harper2@utsouthwestern.edu
Craig G Crandall, PhD, craigcrandall@texashealth.org
About this study
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.
- Being tested
- Simulated burn injury via application of absorbent and impermeable material over 60% of the body
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Hot and Humid with simulated burns | Experimental | Individuals will be exposed to hot and humid conditions with a simulated burn injury. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core Temperature
Measured: From baseline to end of 60 minutes of recovery
Secondary outcomes (1)
Heart Rate
Measured: From baseline to the end of 60 minutes of recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Mar 2026
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn InjuryStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Craig Crandall, University of Texas Southwestern Medical Center
- Investigators
- Craig G Crandall, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050264
- Sponsor's protocol ID
- STU20251344
- Other IDs
- R35GM152112-01
- Acronym
- HSR
- Status last verified
- May 2026
- First submitted
- 25 Jun 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simulated Burn Injury on Post Exercise Recovery in Hot Environments
- ClinicalTrials.gov ID
- NCT07050264
- Acronym / sponsor ID
- HSR / STU20251344
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hot and Humid with simulated burns | Experimental | Other: Simulated burn injury via application of absorbent and impermeable material over 60% of the bodyIndividuals will be exposed to hot and humid conditions with a simulated burn injury. |
| 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 | Other: Simulated burn injury via application of absorbent and impermeable material over 60% of the bodyIndividuals will be exposed to hot and dry conditions with a simulated burn injury. |
| Hot and Dry without simulated burns | No intervention | –Individuals will be exposed to hot and dry conditions without a simulated burn injury. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulated burn injury via application of absorbent and impermeable material over 60% of the bodySimulated burn injury via application of absorbent and impermeable material over 60% of the body | Other | Hot and Dry with simulated burns, Hot and Humid with simulated burns |
Primary outcome
Core Temperature
Time frame: From baseline to end of 60 minutes of recovery
1 secondary outcome
Heart Rate
Time frame: From baseline to the end of 60 minutes of recovery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth A Gideon, PhD contact
Craig G Crandall, PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulated burn injury via application of absorbent and impermeable material over 60% of the body in people with Burn Injury and Body Temperature Regulation, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin M Harper, B.S. (12143454737, erin.harper2@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core Temperature (time frame: From baseline to end of 60 minutes of recovery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.