Trial · Interventional

CompletedPhase 2/3Results postedRegistry data

Assessment of Mechanisms of Improved Wound Healing

NCTNCT00673309Other id00-454Other idP50GM060338Other idR01GM056687Other idSHC #8660

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2/3
Enrollment: 644 participants (actual)
Sponsor: The University of Texas Medical Branch, Galveston · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: Jul 2000
Primary completion: Apr 2011
Completion: Apr 2013
First posted: 7 May 2008 (estimated)
Last update posted: 3 Jul 2023
Conditions: Burns

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200020052010

Ph 2/3
Assessment of Mechanisms of Improved Wound Healing
NCT00673309
Jul 2000 to Apr 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

Stable Isotope Infusion studyProcedure
Insulin High DoseDrug
oxandroloneDrug
PropranololDrug
Growth HormoneDrug
Insulin Low DoseDrug
IGF-1/IGFBP-3Drug
ItraconazoleDrug
Growth Hormone and PropranololDrug
Oxandrolone and PropranololDrug
Placebo or ControlDrug

Arms10

Experimental
Growth Hormone
Growth Hormone administered daily until 95% wound healing. Stable Isotope Infusion Study with collection of blood and tissue
Experimental
Insulin High Dose
Insulin IV administered continuously to 95% healing. Stable Isotope Infusion Study with collection of blood and tissue
Experimental
Oxandrolone
Oxandrolone administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue
Experimental
Propranolol
Propranolol administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue
Experimental
IGF-1/IGFBP-3
IGF-1/IGFBP-3 will be administered until 95% wound healing
Experimental
Insulin Low Dose
Insulin Low Dose will be administered until 95% wound healing.
Experimental
Itraconazole
Itraconazole will be administered until 95% wound healing.
Experimental
Growth Hormone and Propranolol
Growth Hormone and Propranolol will be administered until 95% wound healing.
Experimental
Oxandrolone and Propranolol
Oxandrolone and Propranolol will be administered until 95% wound healing
Placebo comparator
Control/Placebo
Placebo or Control will be administered until 95% wound healing

Primary outcomes1

Outcomes the sponsor listed as primary.

Decrease Hypermetabolism as Measured by Stable Isotope Infusion Study
Time frame · Admission to burn unit to 95% wound healing
Registry description
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.

Secondary outcomes(3)

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· Admission to burn unit to 95% wound healing

Decrease Hypermetabolism as Measured by Stable Isotope Infusion Study

Group	Value
Growth Hormone	not posted
Insulin High Dose	not posted
Oxandrolone	not posted
Propranolol	not posted
IGF-1/IGFBP-3	not posted
Insulin Low Dose	not posted
Itraconazole	not posted
Growth Hormone and Propranolol	not posted
Oxandrolone and Propranolol	not posted
Control/Placebo	not posted

Secondary and other outcome results(3)

Secondary outcome· Admission to burn unit to 95% wound healing

Improved Rate of Wound Healing

Group	Value
Growth Hormone	not posted
Insulin High Dose	not posted
Oxandrolone	not posted
Propranolol	not posted
IGF-1/IGFBP-3	not posted
Insulin Low Dose	not posted
Itraconazole	not posted
Growth Hormone and Propranolol	not posted
Oxandrolone and Propranolol	not posted
Control/Placebo	not posted

Secondary outcome· Admission to burn unit to discharge

Incidence of Morbidity and Mortality

Group	Value
Growth Hormone	not posted
Insulin High Dose	not posted
Oxandrolone	not posted
Propranolol	not posted
IGF-1/IGFBP-3	not posted
Insulin Low Dose	not posted
Itraconazole	not posted
Growth Hormone and Propranolol	not posted
Oxandrolone and Propranolol	not posted
Control/Placebo	not posted

Secondary outcome· Admission to burn unit to 95% wound healing

Incidence of Sepsis

Group	Value
Growth Hormone	not posted
Insulin High Dose	not posted
Oxandrolone	not posted
Propranolol	not posted
IGF-1/IGFBP-3	not posted
Insulin Low Dose	not posted
Itraconazole	not posted
Growth Hormone and Propranolol	not posted
Oxandrolone and Propranolol	not posted
Control/Placebo	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Groupunknown - Shriner's Burn Hospital revoked access to study-related data.. We are unable to submit the additional information or results-data.	–	0 / 0	0 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedZinter 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. PMID 36656551
DerivedKraft 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. PMID 23511841
DerivedJeschke 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. PMID 22606232
DerivedJeschke 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. PMID 21789167
DerivedJeschke 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. PMID 20739853
DerivedJeschke 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. PMID 20395554
DerivedGauglitz 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. PMID 19240154
DerivedJeschke 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. PMID 18791359

Eligibility

Who could join, as posted.

Sex: All
Age: up to 90 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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