Assessment of Mechanisms of Improved Wound Healing

Overview[ - collapse ][ - ]

Purpose The purpose of this study is to find ways to improve wound healing and decrease the negative effects of trauma from burn injury.
ConditionBurns
InterventionProcedure: Collection of blood and tissues
Procedure: Stable Isotope Infusion study
Procedure: Radiology testing: DEXA, K+ counter, ultrasound, MRI
Drug: IGF-1
Drug: Insulin
Drug: oxandrolone
Drug: Propranolol
Drug: Clonidine
Drug: Ketoconazole
Drug: Dehydroepiandrosterone-sulfate
Drug: Fenofibrate
Drug: Metformin
Drug: Byetta
Drug: Growth Hormone
Drug: Pioglitazone
PhasePhase 2/Phase 3
SponsorThe University of Texas, Galveston
Responsible PartyThe University of Texas, Galveston
ClinicalTrials.gov IdentifierNCT00673309
First ReceivedDecember 26, 2007
Last UpdatedMay 4, 2012
Last verifiedMay 2012

Tracking Information[ + expand ][ + ]

First Received DateDecember 26, 2007
Last Updated DateMay 4, 2012
Start DateJuly 2002
Estimated Primary Completion DateApril 2011
Current Primary Outcome MeasuresDecrease hypermetabolism as measured by stable isotope infusion study [Time Frame: Admission to burn unit to 95% wound healing] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Improved rate of wound healing [Time Frame: Admission to burn unit to 95% wound healing] [Designated as safety issue: No]
  • Incidence of morbidity and mortality [Time Frame: Admission to burn unit to discharge] [Designated as safety issue: No]
  • Incidence of sepsis [Time Frame: Admission to burn unit to 95% wound healing] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleAssessment of Mechanisms of Improved Wound Healing
Official TitleAssessment of Mechanisms of Improved Wound Healing of Anabolic Agents and Diet in Severely Burned Patients
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.
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.
Study TypeInterventional
Study PhasePhase 2/Phase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionBurns
InterventionProcedure: Collection of blood and tissues
Blood draw with each stable isotope infusion study and weekly Tissue biopsy: skin, fat, muscle at stable isotope infusion study
Procedure: Stable Isotope Infusion study
1-8 hour stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues.
Procedure: Radiology testing: DEXA, K+ counter, ultrasound, MRI
Testing to be done following every stable isotope infusion study to measure muscle, fat and bone tissues.
Drug: IGF-1
Administration of randomized drug daily throughout hospitalization to 95% wound healing
Other Names:
IGF-1/IGFBP-3Drug: Insulin
Insulin IV administered continuously to maintain serum glucose between 80-110 throughout hospitalization until wounds are 95% healed.
Other Names:
Regular InsulinDrug: oxandrolone
Oxandrolone given daily throughout hospitalization until 95% wound healing.
Other Names:
  • testosterone
  • nandrolone
Drug: Propranolol
Propranolol to be given daily to decrease HR and BP throughout hospitalization until 95% wound healing.
Other Names:
metroprololDrug: Clonidine
Clonidine administered daily throughout hospitalization until 95% wound healing to decrease HR, BP, and anxiety.
Other Names:
CatapresDrug: Ketoconazole
Ketoconazole administered PO every 12 hours throughout hospitalization until 95% wound healing.
Other Names:
  • itraconazole
  • fluconazole
Drug: Dehydroepiandrosterone-sulfate
The hormone Dehydroepiandrosterone-sulfate will be given daily until 95% wound healing.
Other Names:
DHEA-SDrug: Fenofibrate
Fenofibrate administered daily until 95% wound healing.
Other Names:
TricorDrug: Metformin
metformin to be administered daily throughout hospitalization until 95% wound healing.
Other Names:
GlucophageDrug: Byetta
Byetta administered daily throughout hospitalization until 95% wound healing.
Other Names:
  • GLP
  • GLP-1
  • Exenatide
Drug: Growth Hormone
Recombinant Human Growth hormone to be administered daily until 95% wound healing.
Other Names:
  • GH
  • rhGH
  • recombinant human Growth Hormone
Drug: Pioglitazone
Pioglitazone administered daily throughout hospitalization until 95% wound healing
Other Names:
Actos
Study Arm (s)
  • Experimental: 1
    Growth Hormone 0.05 to 0.2 mg/kg q day SQ until 95% wound healing.
  • Experimental: 2
    IGF-1 (or IGF-1/IGFBP-3) administration daily until 95% wound healing
  • Experimental: 3
    Insulin IV administered continuously to maintain serum glucose between 80-110 throughout hospitalization until wounds are 95% healed
  • Experimental: 4
    Oxandrolone (or other Anabolic steroid-nandrolone or testosterone) administered daily until 95% wound healing
  • Experimental: 5
    Propranolol (or other Beta adrenergic blockers-metoprolol) to be given IV or PO to decrease HR and BP throughout hospitalization until 95% wound healing
  • Experimental: 6
    Clonidine (Alpha Adrenergic Agonist) to be given daily to decrease HR and BP and anxiety
  • Experimental: 7
    Ketoconazole (or other glucocorticoid blockers- itraconazole, fluconazole) administered PO every 12 hours throughout hospitalization until 95% wound healing
  • Experimental: 8
    Fenofibrate administered daily until 95% wound healing
  • Experimental: 10
    Pioglitazone administered daily throughout hospitalization to 95% wound healing
  • Experimental: 11
    Byetta (or other Glucagon like peptide drug-GLP, GLP-1, Exenatide) will be administered SQ daily throughout hospitalization until 95% wound healing
  • Placebo Comparator: 12
    Placebo. Sterile water will be administered daily throughout hospitalization to 95% wound healing
  • Experimental: 9
    Metformin PO administered daily throughout hospitalization to 95% wound healing
  • Experimental: 13
    DHEA-S, Dehydroepiandrosterone-sulfate administered daily until 95% wound healing.

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment644
Estimated Completion DateApril 2011
Estimated Primary Completion DateApril 2011
Eligibility 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
GenderBoth
AgesN/A
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00673309
Other Study ID Numbers00-454
Has Data Monitoring CommitteeYes
Information Provided ByThe University of Texas, Galveston
Study SponsorThe University of Texas, Galveston
CollaboratorsNational Institutes of Health (NIH)
Investigators Principal Investigator: David N. Herndon, MD University of Texas
Verification DateMay 2012

Locations[ + expand ][ + ]

University of Texas Medical Branch
Galveston, Texas, United States, 77550