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Assessment of Mechanisms of Improved Wound Healing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00673309
Recruitment Status : Completed
First Posted : May 7, 2008
Results First Posted : December 16, 2019
Last Update Posted : December 16, 2019
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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

Condition or disease Intervention/treatment Phase
Burns Procedure: Stable Isotope Infusion study Drug: Insulin High Dose Drug: oxandrolone Drug: Propranolol Drug: Growth Hormone Drug: Insulin Low Dose Drug: IGF-1/IGFBP-3 Drug: Itraconazole Drug: Growth Hormone and Propranolol Drug: Oxandrolone and Propranolol Drug: Placebo or Control Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 644 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Mechanisms of Improved Wound Healing of Anabolic Agents and Diet in Severely Burned Patients
Study Start Date : July 2000
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Growth Hormone
Growth Hormone administered daily until 95% wound healing. Stable Isotope Infusion Study with collection of blood and tissue
Procedure: 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)

Drug: Growth Hormone
Recombinant Human Growth hormone to be administered daily until 95% wound healing.
Other Names:
  • GH
  • rhGH
  • recombinant human Growth Hormone

Experimental: Insulin High Dose
Insulin IV administered continuously to 95% healing. Stable Isotope Infusion Study with collection of blood and tissue
Procedure: 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)

Drug: Insulin High Dose
Insulin IV administered continuously throughout hospitalization until wounds are 95% healed.
Other Name: Regular Insulin

Experimental: Oxandrolone
Oxandrolone administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue
Procedure: 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)

Drug: oxandrolone
Oxandrolone given daily throughout hospitalization until 95% wound healing.
Other Name: nandrolone

Experimental: Propranolol
Propranolol administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue
Procedure: 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)

Drug: Propranolol
Propranolol to be given daily throughout hospitalization until 95% wound healing.

Experimental: IGF-1/IGFBP-3
IGF-1/IGFBP-3 will be administered until 95% wound healing
Procedure: 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)

Drug: IGF-1/IGFBP-3
Insulin Like Growth Factor-1/Insulin like Growth Factor Binding Protein 3 administered until 95% wound healing
Other Name: Insulin Like Growth Factor

Experimental: Insulin Low Dose
Insulin Low Dose will be administered until 95% wound healing.
Procedure: 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)

Drug: Insulin Low Dose
Insulin administered IV until 95% wound healing
Other Name: Insulin

Experimental: Itraconazole
Itraconazole will be administered until 95% wound healing.
Procedure: 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)

Drug: Itraconazole
Itraconazole administered until 95% wound healing

Experimental: Growth Hormone and Propranolol
Growth Hormone and Propranolol will be administered until 95% wound healing.
Procedure: 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)

Drug: Growth Hormone and Propranolol
Growth Hormone and Propranolol given until 95% wound healing
Other Name: GH and Propranolol

Experimental: Oxandrolone and Propranolol
Oxandrolone and Propranolol will be administered until 95% wound healing
Procedure: 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)

Drug: Oxandrolone and Propranolol
Oxandrolone and Propranolol

Placebo Comparator: Control/Placebo
Placebo or Control will be administered until 95% wound healing
Procedure: 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)

Drug: Placebo or Control
Administration of Placebo or Control until 95% wound healing




Primary Outcome Measures :
  1. Decrease Hypermetabolism as Measured by Stable Isotope Infusion Study [ Time Frame: Admission to burn unit to 95% wound healing ]
    Shriner's Burn Hospital revoked access to study-related data.. We are unable to submit the additional information or results-data.


Secondary Outcome Measures :
  1. Improved Rate of Wound Healing [ Time Frame: Admission to burn unit to 95% wound healing ]
    Shriner's Burn Hospital revoked access to study-related data.. We are unable to submit the additional information or results-data.

  2. Incidence of Morbidity and Mortality [ Time Frame: Admission to burn unit to discharge ]
    Shriner's Burn Hospital revoked access to study-related data.. We are unable to submit the additional information or results-data.

  3. Incidence of Sepsis [ Time Frame: Admission to burn unit to 95% wound healing ]
    Shriner's Burn Hospital revoked access to study-related data.. We are unable to submit the additional information or results-data.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00673309


Locations
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United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77550
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
National Institute of General Medical Sciences (NIGMS)
Investigators
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Principal Investigator: David N. Herndon, MD University of Texas
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00673309    
Other Study ID Numbers: 00-454
P50GM060338 ( U.S. NIH Grant/Contract )
R01GM056687 ( U.S. NIH Grant/Contract )
SHC #8660 ( Other Grant/Funding Number: Shriners Hospital for children )
First Posted: May 7, 2008    Key Record Dates
Results First Posted: December 16, 2019
Last Update Posted: December 16, 2019
Last Verified: August 2018
Keywords provided by The University of Texas Medical Branch, Galveston:
burns
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Itraconazole
Propranolol
Hormones
Oxandrolone
Nandrolone
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Cytochrome P-450 CYP3A Inhibitors
Androgens
Anabolic Agents