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. |
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Condition | Burns |
Intervention | Procedure: 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 |
Phase | Phase 2/Phase 3 |
Sponsor | The University of Texas, Galveston |
Responsible Party | The University of Texas, Galveston |
ClinicalTrials.gov Identifier | NCT00673309 |
First Received | December 26, 2007 |
Last Updated | May 4, 2012 |
Last verified | May 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | December 26, 2007 |
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Last Updated Date | May 4, 2012 |
Start Date | July 2002 |
Estimated Primary Completion Date | April 2011 |
Current Primary Outcome Measures | Decrease 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 |
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Descriptive Information[ + expand ][ + ]
Brief Title | Assessment of Mechanisms of Improved Wound Healing |
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Official Title | Assessment 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 Type | Interventional |
Study Phase | Phase 2/Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Burns |
Intervention | Procedure: 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:
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:
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:
Recombinant Human Growth hormone to be administered daily until 95% wound healing. Other Names:
Pioglitazone administered daily throughout hospitalization until 95% wound healing Other Names: Actos |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 644 |
Estimated Completion Date | April 2011 |
Estimated Primary Completion Date | April 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 |
Gender | Both |
Ages | N/A |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00673309 |
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Other Study ID Numbers | 00-454 |
Has Data Monitoring Committee | Yes |
Information Provided By | The University of Texas, Galveston |
Study Sponsor | The University of Texas, Galveston |
Collaborators | National Institutes of Health (NIH) |
Investigators | Principal Investigator: David N. Herndon, MD University of Texas |
Verification Date | May 2012 |
Locations[ + expand ][ + ]
University of Texas Medical Branch | Galveston, Texas, United States, 77550 |
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