BurnsPhase 2/3NCT00673309

Assessment of Mechanisms of Improved Wound Healing

A Phase 2/3 study testing Stable Isotope Infusion study, Insulin High Dose and oxandrolone in people with Burns, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to find ways to improve wound healing and decrease the negative effects of trauma from burn injury. Read more about this study

Who is it for?: Ages Up to 90 years
Conditions the study is for: Burns
What is being tested?: Stable Isotope Infusion study, Insulin High Dose and oxandrolone
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 644 participants
Where: 1 siteUnited States
Study dates: Jul 2000to Apr 2013
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Up to 90 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patient is between 0 and 90 years of age
Patient 18 years and older consents to participate in study protocol. If patient is not able to consent, consent will be obtained from closest family member or legal guardian. Parental permission will be obtained for patients less than 18 years of age. Assent will be obtained from children 7-17 years of age if child is physically/mentally able to do so.
greater than 30% TBSA burn requiring at least 1 operation with donor sites for skin grafting

Who cannot join

Known history of AIDS, AIDS-related complex, Human Immunodeficiency Virus
History of cancer within 5 years
Tuberculosis, arthritis, cirrhosis, hyperlipidemia, bone or endocrine diseases, autoimmune diseases
Chronic glucocorticoid or non-steroidal anti-inflammatory drug therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Texas Medical Branch
Galveston, Texas, 77550

Other trials in United States

About this study

Official title: Assessment of Mechanisms of Improved Wound Healing of Anabolic Agents and Diet in Severely Burned Patients

The purpose of this study is to find ways to improve wound healing and decrease the negative effects of trauma from burn injury.

Read the detailed description

This study involves research and the investigators hope to learn the following: how or what effect one or more anabolic ("tissue building") agents have on muscle metabolism, wound healing, and immune function after severe burn. The agents include the following: growth hormone, insulin-like growth factor-1 in combination with its binding proteins, insulin, Beta-adrenergic blockers, Alpha Adrenergic Agonist, anabolic steroids such as testosterone, Oxandrolone and nandrolone, ketoconazole and its derivatives, dehydroepiandrosterone, fenofibrate, diet or the application of skin substitute.

Conditions: Burns
Being tested: Stable Isotope Infusion study, Insulin High Dose, oxandrolone, Propranolol, Growth Hormone
Keywords: burns
Medical subject headings: Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Stable Isotope Infusion studyProcedure or surgery
Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)
Insulin High DoseDrug
Also called Regular Insulin
Insulin IV administered continuously throughout hospitalization until wounds are 95% healed.
oxandroloneDrug
Also called nandrolone
Oxandrolone given daily throughout hospitalization until 95% wound healing.
PropranololDrug
Propranolol to be given daily throughout hospitalization until 95% wound healing.
Growth HormoneDrug
Also called GH, rhGH, recombinant human Growth Hormone
Recombinant Human Growth hormone to be administered daily until 95% wound healing.
Insulin Low DoseDrug
Also called Insulin
Insulin administered IV until 95% wound healing
IGF-1/IGFBP-3Drug
Also called Insulin Like Growth Factor
Insulin Like Growth Factor-1/Insulin like Growth Factor Binding Protein 3 administered until 95% wound healing
ItraconazoleDrug
Itraconazole administered until 95% wound healing
Growth Hormone and PropranololDrug
Also called GH and Propranolol
Growth Hormone and Propranolol given until 95% wound healing
Oxandrolone and PropranololDrug
Oxandrolone and Propranolol
Placebo or ControlDrug
Administration of Placebo or Control until 95% wound healing

Study groups in NCT00673309
Study group	Role	What they receive
Growth Hormone	Experimental	Growth Hormone administered daily until 95% wound healing. Stable Isotope Infusion Study with collection of blood and tissue Receives: Procedure: Stable Isotope Infusion study; Drug: Growth Hormone
Insulin High Dose	Experimental	Insulin IV administered continuously to 95% healing. Stable Isotope Infusion Study with collection of blood and tissue Receives: Procedure: Stable Isotope Infusion study; Drug: Insulin High Dose
Oxandrolone	Experimental	Oxandrolone administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue Receives: Procedure: Stable Isotope Infusion study; Drug: oxandrolone
Propranolol	Experimental	Propranolol administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue Receives: Procedure: Stable Isotope Infusion study; Drug: Propranolol
IGF-1/IGFBP-3	Experimental	IGF-1/IGFBP-3 will be administered until 95% wound healing Receives: Procedure: Stable Isotope Infusion study; Drug: IGF-1/IGFBP-3
Insulin Low Dose	Experimental	Insulin Low Dose will be administered until 95% wound healing. Receives: Procedure: Stable Isotope Infusion study; Drug: Insulin Low Dose
Itraconazole	Experimental	Itraconazole will be administered until 95% wound healing. Receives: Procedure: Stable Isotope Infusion study; Drug: Itraconazole
Growth Hormone and Propranolol	Experimental	Growth Hormone and Propranolol will be administered until 95% wound healing. Receives: Procedure: Stable Isotope Infusion study; Drug: Growth Hormone and Propranolol
Oxandrolone and Propranolol	Experimental	Oxandrolone and Propranolol will be administered until 95% wound healing Receives: Procedure: Stable Isotope Infusion study; Drug: Oxandrolone and Propranolol
Control/Placebo	Placebo comparator	Placebo or Control will be administered until 95% wound healing Receives: Procedure: Stable Isotope Infusion study; Drug: Placebo or Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Decrease Hypermetabolism as Measured by Stable Isotope Infusion Study
At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are.
Measured: Admission to burn unit to 95% wound healing

Secondary outcomes (3)

Improved Rate of Wound Healing
At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are.
Measured: Admission to burn unit to 95% wound healing
Incidence of Morbidity and Mortality
At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are.
Measured: Admission to burn unit to discharge
Incidence of Sepsis
At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are.
Measured: Admission to burn unit to 95% wound healing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2000Apr 2013

First posted7 May 2008 (estimated)
Study startJul 2000
Primary completionApr 2011
Study completionApr 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for BurnsStudies of the same condition, open and under way.
More trials run by The University of Texas Medical Branch, GalvestonThe 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 644 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00673309
Sponsor's protocol ID: 00-454
Other IDs: P50GM060338, R01GM056687, SHC #8660
Status last verified: Jun 2023
First submitted: 26 Dec 2007
Last updated: 3 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Zinter MS, Markovic D, Asaro LA, Nadkarni VM, McQuillen PS, Sinha P, Matthay MA, Jeschke MG, Agus MSD, Sapru A; CAF-PINT Investigators of the PALISI Network. Tight Glycemic Control, Inflammation, and the ICU: Evidence for Heterogeneous Treatment Effects in Two Randomized Controlled Trials. Am J Respir Crit Care Med. 2023 Apr 1;207(7):945-949. doi: 10.1164/rccm.202210-1988LE. No abstract available.
PubMed 36656551
Kraft R, Herndon DN, Finnerty CC, Shahrokhi S, Jeschke MG. Occurrence of multiorgan dysfunction in pediatric burn patients: incidence and clinical outcome. Ann Surg. 2014 Feb;259(2):381-7. doi: 10.1097/SLA.0b013e31828c4d04.
PubMed 23511841
Jeschke MG, Williams FN, Finnerty CC, Rodriguez NA, Kulp GA, Ferrando A, Norbury WB, Suman OE, Kraft R, Branski LK, Al-mousawi AM, Herndon DN. The effect of ketoconazole on post-burn inflammation, hypermetabolism and clinical outcomes. PLoS One. 2012;7(5):e35465. doi: 10.1371/journal.pone.0035465. Epub 2012 May 11.
PubMed 22606232
Jeschke MG, Gauglitz GG, Kulp GA, Finnerty CC, Williams FN, Kraft R, Suman OE, Mlcak RP, Herndon DN. Long-term persistance of the pathophysiologic response to severe burn injury. PLoS One. 2011;6(7):e21245. doi: 10.1371/journal.pone.0021245. Epub 2011 Jul 18.
PubMed 21789167
Jeschke MG, Kraft R, Emdad F, Kulp GA, Williams FN, Herndon DN. Glucose control in severely thermally injured pediatric patients: what glucose range should be the target? Ann Surg. 2010 Sep;252(3):521-7; discussion 527-8. doi: 10.1097/SLA.0b013e3181f2774c.
PubMed 20739853
Mecott GA, Herndon DN, Kulp GA, Brooks NC, Al-Mousawi AM, Kraft R, Rivero HG, Williams FN, Branski LK, Jeschke MG. The use of exenatide in severely burned pediatric patients. Crit Care. 2010;14(4):R153. doi: 10.1186/cc9222. Epub 2010 Aug 11.
PubMed 20701787
Jeschke MG, Kulp GA, Kraft R, Finnerty CC, Mlcak R, Lee JO, Herndon DN. Intensive insulin therapy in severely burned pediatric patients: a prospective randomized trial. Am J Respir Crit Care Med. 2010 Aug 1;182(3):351-9. doi: 10.1164/rccm.201002-0190OC. Epub 2010 Apr 15.
PubMed 20395554
Gauglitz GG, Herndon DN, Kulp GA, Meyer WJ 3rd, Jeschke MG. Abnormal insulin sensitivity persists up to three years in pediatric patients post-burn. J Clin Endocrinol Metab. 2009 May;94(5):1656-64. doi: 10.1210/jc.2008-1947. Epub 2009 Feb 24.
PubMed 19240154
Jeschke MG, Chinkes DL, Finnerty CC, Kulp G, Suman OE, Norbury WB, Branski LK, Gauglitz GG, Mlcak RP, Herndon DN. Pathophysiologic response to severe burn injury. Ann Surg. 2008 Sep;248(3):387-401. doi: 10.1097/SLA.0b013e3181856241.
PubMed 18791359

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
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RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
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All Burns trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Mechanisms of Improved Wound Healing of Anabolic Agents and Diet in Severely Burned Patients
ClinicalTrials.gov ID: NCT00673309
Acronym / sponsor ID: 00-454
Conditions: Burns
Keywords: burns
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 644 participants (actual)
Lead sponsor: The University of Texas Medical Branch, GalvestonUniversity, hospital or other
Collaborators: National Institute of General Medical Sciences (NIGMS)
Study start: Jul 2000
Primary completion: Apr 2011 (actual)
Study completion: Apr 2013 (actual)
First posted: 7 May 2008 (estimated)
Results: Posted 16 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to find ways to improve wound healing and decrease the negative effects of trauma from burn injury.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 10

Arm	Type	Receives
Growth Hormone	Experimental	Procedure: Stable Isotope Infusion study, Drug: Growth HormoneGrowth Hormone administered daily until 95% wound healing. Stable Isotope Infusion Study with collection of blood and tissue
Insulin High Dose	Experimental	Procedure: Stable Isotope Infusion study, Drug: Insulin High DoseInsulin IV administered continuously to 95% healing. Stable Isotope Infusion Study with collection of blood and tissue
Oxandrolone	Experimental	Procedure: Stable Isotope Infusion study, Drug: oxandroloneOxandrolone administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue
Propranolol	Experimental	Procedure: Stable Isotope Infusion study, Drug: PropranololPropranolol administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue
IGF-1/IGFBP-3	Experimental	Procedure: Stable Isotope Infusion study, Drug: IGF-1/IGFBP-3IGF-1/IGFBP-3 will be administered until 95% wound healing
Insulin Low Dose	Experimental	Procedure: Stable Isotope Infusion study, Drug: Insulin Low DoseInsulin Low Dose will be administered until 95% wound healing.
Itraconazole	Experimental	Procedure: Stable Isotope Infusion study, Drug: ItraconazoleItraconazole will be administered until 95% wound healing.
Growth Hormone and Propranolol	Experimental	Procedure: Stable Isotope Infusion study, Drug: Growth Hormone and PropranololGrowth Hormone and Propranolol will be administered until 95% wound healing.
Oxandrolone and Propranolol	Experimental	Procedure: Stable Isotope Infusion study, Drug: Oxandrolone and PropranololOxandrolone and Propranolol will be administered until 95% wound healing
Control/Placebo	Placebo comparator	Procedure: Stable Isotope Infusion study, Drug: Placebo or ControlPlacebo or Control will be administered until 95% wound healing

Who may qualify

Ages: Up to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Patient is between 0 and 90 years of age
Patient 18 years and older consents to participate in study protocol. If patient is not able to consent, consent will be obtained from closest family member or legal guardian. Parental permission will be obtained for patients less than 18 years of age. Assent will be obtained from children 7-17 years of age if child is physically/mentally able to do so.
greater than 30% TBSA burn requiring at least 1 operation with donor sites for skin grafting

Key exclusion criteria (4 listed)

Known history of AIDS, AIDS-related complex, Human Immunodeficiency Virus
History of cancer within 5 years
Tuberculosis, arthritis, cirrhosis, hyperlipidemia, bone or endocrine diseases, autoimmune diseases
Chronic glucocorticoid or non-steroidal anti-inflammatory drug therapy

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
Stable Isotope Infusion studyStable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)	Procedure or surgery	Control/Placebo, Growth Hormone, Growth Hormone and Propranolol, IGF-1/IGFBP-3, Insulin High Dose, Insulin Low Dose, Itraconazole, Oxandrolone, Oxandrolone and Propranolol, Propranolol
Insulin High DoseAlso: Regular InsulinInsulin IV administered continuously throughout hospitalization until wounds are 95% healed.	Drug	Insulin High Dose
oxandroloneAlso: nandroloneOxandrolone given daily throughout hospitalization until 95% wound healing.	Drug	Oxandrolone
PropranololPropranolol to be given daily throughout hospitalization until 95% wound healing.	Drug	Propranolol
Growth HormoneAlso: GH, rhGH, recombinant human Growth HormoneRecombinant Human Growth hormone to be administered daily until 95% wound healing.	Drug	Growth Hormone
Insulin Low DoseAlso: InsulinInsulin administered IV until 95% wound healing	Drug	Insulin Low Dose
IGF-1/IGFBP-3Also: Insulin Like Growth FactorInsulin Like Growth Factor-1/Insulin like Growth Factor Binding Protein 3 administered until 95% wound healing	Drug	IGF-1/IGFBP-3
ItraconazoleItraconazole administered until 95% wound healing	Drug	Itraconazole
Growth Hormone and PropranololAlso: GH and PropranololGrowth Hormone and Propranolol given until 95% wound healing	Drug	Growth Hormone and Propranolol
Oxandrolone and PropranololOxandrolone and Propranolol	Drug	Oxandrolone and Propranolol
Placebo or ControlAdministration of Placebo or Control until 95% wound healing	Drug	Control/Placebo

Primary outcome

Decrease Hypermetabolism as Measured by Stable Isotope Infusion Study
Time frame: Admission to burn unit to 95% wound healing
At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are.

3 secondary outcomes

Improved Rate of Wound Healing
Time frame: Admission to burn unit to 95% wound healing
Incidence of Morbidity and Mortality
Time frame: Admission to burn unit to discharge
Incidence of Sepsis
Time frame: Admission to burn unit to 95% wound healing

Results and safety

Results posted to the registry on 16 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Growth Hormone Administration	64	64
Insulin High Dose Administration	14	14
Oxandrolone Administration	14	14
Propranolol Administration	25	25
Itraconazole Administration	18	18
IGF-1/IGFBP-3 Comparator	35	35
Insulin Low Dose Administration	14	14
Growth Hormone and Propranolol Administration	13	13
Oxandrolone and Propranolol	17	17
Control or Placebo	30	30

Primary outcome: Decrease Hypermetabolism as Measured by Stable Isotope Infusion Study

Time frame: Admission to burn unit to 95% wound healing

Population analysed: At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EG000	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36656551Zinter MS, Markovic D, Asaro LA, Nadkarni VM, McQuillen PS, Sinha P, Matthay MA, Jeschke MG, Agus MSD, Sapru A; CAF-PINT Investigators of the PALISI Network. Tight Glycemic Control, Inflammation, and the ICU: Evidence for Heterogeneous Treatment Effects in Two Randomized Controlled Trials. Am J Respir Crit Care Med. 2023 Apr 1;207(7):945-949. doi: 10.1164/rccm.202210-1988LE. No abstract available.
Derived from this study: PubMed 23511841Kraft R, Herndon DN, Finnerty CC, Shahrokhi S, Jeschke MG. Occurrence of multiorgan dysfunction in pediatric burn patients: incidence and clinical outcome. Ann Surg. 2014 Feb;259(2):381-7. doi: 10.1097/SLA.0b013e31828c4d04.
Derived from this study: PubMed 22606232Jeschke MG, Williams FN, Finnerty CC, Rodriguez NA, Kulp GA, Ferrando A, Norbury WB, Suman OE, Kraft R, Branski LK, Al-mousawi AM, Herndon DN. The effect of ketoconazole on post-burn inflammation, hypermetabolism and clinical outcomes. PLoS One. 2012;7(5):e35465. doi: 10.1371/journal.pone.0035465. Epub 2012 May 11.
Derived from this study: PubMed 21789167Jeschke MG, Gauglitz GG, Kulp GA, Finnerty CC, Williams FN, Kraft R, Suman OE, Mlcak RP, Herndon DN. Long-term persistance of the pathophysiologic response to severe burn injury. PLoS One. 2011;6(7):e21245. doi: 10.1371/journal.pone.0021245. Epub 2011 Jul 18.
Derived from this study: PubMed 20739853Jeschke MG, Kraft R, Emdad F, Kulp GA, Williams FN, Herndon DN. Glucose control in severely thermally injured pediatric patients: what glucose range should be the target? Ann Surg. 2010 Sep;252(3):521-7; discussion 527-8. doi: 10.1097/SLA.0b013e3181f2774c.
Derived from this study: PubMed 20701787Mecott GA, Herndon DN, Kulp GA, Brooks NC, Al-Mousawi AM, Kraft R, Rivero HG, Williams FN, Branski LK, Jeschke MG. The use of exenatide in severely burned pediatric patients. Crit Care. 2010;14(4):R153. doi: 10.1186/cc9222. Epub 2010 Aug 11.
Derived from this study: PubMed 20395554Jeschke MG, Kulp GA, Kraft R, Finnerty CC, Mlcak R, Lee JO, Herndon DN. Intensive insulin therapy in severely burned pediatric patients: a prospective randomized trial. Am J Respir Crit Care Med. 2010 Aug 1;182(3):351-9. doi: 10.1164/rccm.201002-0190OC. Epub 2010 Apr 15.
Derived from this study: PubMed 19240154Gauglitz GG, Herndon DN, Kulp GA, Meyer WJ 3rd, Jeschke MG. Abnormal insulin sensitivity persists up to three years in pediatric patients post-burn. J Clin Endocrinol Metab. 2009 May;94(5):1656-64. doi: 10.1210/jc.2008-1947. Epub 2009 Feb 24.
Derived from this study: PubMed 18791359Jeschke MG, Chinkes DL, Finnerty CC, Kulp G, Suman OE, Norbury WB, Branski LK, Gauglitz GG, Mlcak RP, Herndon DN. Pathophysiologic response to severe burn injury. Ann Surg. 2008 Sep;248(3):387-401. doi: 10.1097/SLA.0b013e3181856241.

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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. This study is not recruiting at the moment.

David N. Herndon, MD principal investigator

University of Texas

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Stable Isotope Infusion study, Insulin High Dose and oxandrolone in people with Burns, run by The University of Texas Medical Branch, Galveston 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 3 Jul 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease Hypermetabolism as Measured by Stable Isotope Infusion Study (time frame: Admission to burn unit to 95% wound healing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00673309, which also lists 9 linked publications.

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 3 Jul 2023.