A Phase 2/3 interventional study of Stable Isotope Infusion study and Insulin High Dose in Burns, sponsored by The University of Texas Medical Branch, Galveston. Completed at 1 site in United States. Open to participants aged Up to 90 Years. Per ClinicalTrials.gov, last updated 2023-07-03.
Sponsored by The University of Texas Medical Branch, Galveston · Phase 2/3, Interventional, and Treatment
The purpose of this study is to find ways to improve wound healing and decrease the negative effects of trauma from burn injury.
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.
730 studies on the registry are indexed under Burns; 146 are open to participants now.
This study's enrollment of 644 is above the median of 40 across 534 interventional studies indexed under Burns.
Browse Burns studies →The University of Texas Medical Branch, Galveston is the lead sponsor of 256 studies on the registry; 39 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Growth Hormone administered daily until 95% wound healing. Stable Isotope Infusion Study with collection of blood and tissue
Procedure: Stable Isotope Infusion study · Drug: Growth Hormone
Insulin IV administered continuously to 95% healing. Stable Isotope Infusion Study with collection of blood and tissue
Procedure: Stable Isotope Infusion study · Drug: Insulin High Dose
Oxandrolone administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue
Procedure: Stable Isotope Infusion study · Drug: oxandrolone
Propranolol administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue
Procedure: Stable Isotope Infusion study · Drug: Propranolol
IGF-1/IGFBP-3 will be administered until 95% wound healing
Procedure: Stable Isotope Infusion study · Drug: IGF-1/IGFBP-3
Insulin Low Dose will be administered until 95% wound healing.
Procedure: Stable Isotope Infusion study · Drug: Insulin Low Dose
Itraconazole will be administered until 95% wound healing.
Procedure: Stable Isotope Infusion study · Drug: Itraconazole
Growth Hormone and Propranolol will be administered until 95% wound healing.
Procedure: Stable Isotope Infusion study · Drug: Growth Hormone and Propranolol
Oxandrolone and Propranolol will be administered until 95% wound healing
Procedure: Stable Isotope Infusion study · Drug: Oxandrolone and Propranolol
Placebo or Control will be administered until 95% wound healing
Procedure: Stable Isotope Infusion study · Drug: Placebo or Control
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 IV administered continuously throughout hospitalization until wounds are 95% healed.
Also known as: Regular Insulin
Oxandrolone given daily throughout hospitalization until 95% wound healing.
Also known as: nandrolone
Propranolol to be given daily throughout hospitalization until 95% wound healing.
Recombinant Human Growth hormone to be administered daily until 95% wound healing.
Also known as: GH, rhGH, recombinant human Growth Hormone
Insulin administered IV until 95% wound healing
Also known as: Insulin
Drug page: Mecasermin
Insulin Like Growth Factor-1/Insulin like Growth Factor Binding Protein 3 administered until 95% wound healing
Also known as: Insulin Like Growth Factor
Itraconazole administered until 95% wound healing
Drug pages: Growth Hormone · Propranolol
Growth Hormone and Propranolol given until 95% wound healing
Also known as: GH and Propranolol
Drug pages: Oxandrolone · Propranolol
Oxandrolone and Propranolol
Administration of Placebo or Control until 95% wound healing
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.
Time frame: Admission to burn unit to 95% wound healing
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.
Time frame: 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.
Time frame: 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.
Time frame: Admission to burn unit to 95% wound healing
Patients admitted to burn unit with \>40% burn or greater
| Milestone | Growth Hormone Administration | Insulin High Dose Administration | Oxandrolone Administration | Propranolol Administration | Itraconazole Administration | IGF-1/IGFBP-3 Comparator | Insulin Low Dose Administration | Growth Hormone and Propranolol Administration | Oxandrolone and Propranolol | Control or Placebo |
|---|---|---|---|---|---|---|---|---|---|---|
| Started | 64 | 14 | 14 | 25 | 18 | 35 | 14 | 13 | 17 | 30 |
| Completed | 64 | 14 | 14 | 25 | 18 | 35 | 14 | 13 | 17 | 30 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group | — | — | — |
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.
| Age, Continuous | Growth Hormone Administration | Insulin High Dose Administration | Oxandrolone Administration | Propranolol Administration | Itraconazole Administration | IGF-1/IGFBP-3 Comparator | Insulin Low Dose Administration | Growth Hormone and Propranolol Administration | Oxandrolone and Propranolol | Control or Placebo | Total |
|---|
| Sex: Female, Male | Growth Hormone Administration | Insulin High Dose Administration | Oxandrolone Administration | Propranolol Administration | Itraconazole Administration | IGF-1/IGFBP-3 Comparator | Insulin Low Dose Administration | Growth Hormone and Propranolol Administration | Oxandrolone and Propranolol | Control or Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | — | — | — | — | — | — | — | — | — | — | — |
| Male | — | — | — | — | — | — | — | — | — | — | — |
| Protein Net Balance | Growth Hormone Administration | Insulin High Dose Administration | Oxandrolone Administration | Propranolol Administration | Itraconazole Administration | IGF-1/IGFBP-3 Comparator | Insulin Low Dose Administration | Growth Hormone and Propranolol Administration | Oxandrolone and Propranolol | Control or Placebo | Total |
|---|
The record gives a start of Jul 2000, a primary completion of Apr 2011 and a completion of Apr 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2019, 8 years 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Insulin · Oxandrolone · Propranolol · Growth Hormone · Mecasermin · Itraconazole
The University of Texas Medical Branch, Galveston →