Trial Outcomes & Findings for Assessment of Mechanisms of Improved Wound Healing (NCT NCT00673309)
NCT ID: NCT00673309
Last Updated: 2023-07-03
Results Overview
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.
COMPLETED
PHASE2/PHASE3
644 participants
Admission to burn unit to 95% wound healing
2023-07-03
Participant Flow
Patients admitted to burn unit with \>40% burn or greater
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.
Participant milestones
| Measure |
Growth Hormone Administration
Growth Hormone administered daily until 95% wound healing. Stable Isotope Infusion Study with collection of blood and tissue
Stable Isotope Infusion study: 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)
Growth Hormone: Recombinant Human Growth hormone to be administered daily until 95% wound healing.
|
Insulin High Dose Administration
Insulin IV administered continuously to 95% healing. Stable Isotope Infusion Study with collection of blood and tissue
Stable Isotope Infusion study: 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: Insulin IV administered continuously throughout hospitalization until wounds are 95% healed.
|
Oxandrolone Administration
Oxandrolone administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue
Stable Isotope Infusion study: 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)
oxandrolone: Oxandrolone given daily throughout hospitalization until 95% wound healing.
|
Propranolol Administration
Propranolol administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue
Stable Isotope Infusion study: 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)
Propranolol: Propranolol to be given daily throughout hospitalization until 95% wound healing.
|
Itraconazole Administration
Itraconazole administered throughout hospitalization until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue
Stable Isotope Infusion study: 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)
Itraconazole administered throughout hospitalization until 95% wound healing.
|
IGF-1/IGFBP-3 Comparator
IGF-1/IGFBP-3 administered daily to 95% wound healing. Stable Isotope Infusion Study with collection of blood and tissue
Stable Isotope Infusion study: 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)
IGF-1/IGFBP-3 administered until 95% wound healing
|
Insulin Low Dose Administration
Insulin IV administered continuously through hospitalization to 95% wound healing.
|
Growth Hormone and Propranolol Administration
Growth Hormone and Propranolol administration throughout hospitalization to 95% wound healing.
Includes stable isotope infusion studies.
|
Oxandrolone and Propranolol
Oxandrolone and Propranolol administration throughout hospitalization to 95% wound healing.
Includes stable isotope infusion studies
|
Control or Placebo
Control or Placebo administered through hospitalization to 95% wound healing. Includes stable isotope infusion studies.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
64
|
14
|
14
|
25
|
18
|
35
|
14
|
13
|
17
|
30
|
|
Overall Study
COMPLETED
|
64
|
14
|
14
|
25
|
18
|
35
|
14
|
13
|
17
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of Mechanisms of Improved Wound Healing
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Admission to burn unit to 95% wound healingPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Admission to burn unit to 95% wound healingPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Admission to burn unit to dischargePopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Admission to burn unit to 95% wound healingPopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Tina Mack-Moshay- ClinicalTrials.gov Administrator
University of Texas Medical Branch
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place