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Assessment of Mechanisms of Improved Wound Healing

This study has been completed.
Sponsor:
Collaborator:
Information provided by (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
  Purpose

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


Condition Intervention Phase
Burns
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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Mechanisms of Improved Wound Healing of Anabolic Agents and Diet in Severely Burned Patients

Resource links provided by NLM:


Further study details as provided by The University of Texas, Galveston:

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 ]

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 ]

Enrollment: 644
Study Start Date: July 2002
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Growth Hormone 0.05 to 0.2 mg/kg q day SQ until 95% wound healing.
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: Growth Hormone
Recombinant Human Growth hormone to be administered daily until 95% wound healing.
Other Names:
  • GH
  • rhGH
  • recombinant human Growth Hormone
Experimental: 2
IGF-1 (or IGF-1/IGFBP-3) administration daily until 95% wound healing
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 Name: IGF-1/IGFBP-3
Experimental: 3
Insulin IV administered continuously to maintain serum glucose between 80-110 throughout hospitalization until wounds are 95% healed
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: Insulin
Insulin IV administered continuously to maintain serum glucose between 80-110 throughout hospitalization until wounds are 95% healed.
Other Name: Regular Insulin
Experimental: 4
Oxandrolone (or other Anabolic steroid-nandrolone or testosterone) administered daily until 95% wound healing
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: oxandrolone
Oxandrolone given daily throughout hospitalization until 95% wound healing.
Other Names:
  • testosterone
  • nandrolone
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
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: Propranolol
Propranolol to be given daily to decrease HR and BP throughout hospitalization until 95% wound healing.
Other Name: metroprolol
Experimental: 6
Clonidine (Alpha Adrenergic Agonist) to be given daily to decrease HR and BP and anxiety
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: Clonidine
Clonidine administered daily throughout hospitalization until 95% wound healing to decrease HR, BP, and anxiety.
Other Name: Catapres
Experimental: 7
Ketoconazole (or other glucocorticoid blockers- itraconazole, fluconazole) administered PO every 12 hours throughout hospitalization until 95% wound healing
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: Ketoconazole
Ketoconazole administered PO every 12 hours throughout hospitalization until 95% wound healing.
Other Names:
  • itraconazole
  • fluconazole
Experimental: 8
Fenofibrate administered daily until 95% wound healing
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: Fenofibrate
Fenofibrate administered daily until 95% wound healing.
Other Name: Tricor
Experimental: 10
Pioglitazone administered daily throughout hospitalization to 95% wound healing
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: Pioglitazone
Pioglitazone administered daily throughout hospitalization until 95% wound healing
Other Name: Actos
Experimental: 11
Byetta (or other Glucagon like peptide drug-GLP, GLP-1, Exenatide) will be administered SQ daily throughout hospitalization until 95% wound healing
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: Byetta
Byetta administered daily throughout hospitalization until 95% wound healing.
Other Names:
  • GLP
  • GLP-1
  • Exenatide
Placebo Comparator: 12
Placebo. Sterile water will be administered daily throughout hospitalization to 95% wound healing
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.
Experimental: 9
Metformin PO administered daily throughout hospitalization to 95% wound healing
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: Metformin
metformin to be administered daily throughout hospitalization until 95% wound healing.
Other Name: Glucophage
Experimental: 13
DHEA-S, Dehydroepiandrosterone-sulfate administered daily until 95% wound healing.
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: Dehydroepiandrosterone-sulfate
The hormone Dehydroepiandrosterone-sulfate will be given daily until 95% wound healing.
Other Name: DHEA-S

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.

  Eligibility

Ages Eligible for Study:   up to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673309

Locations
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77550
Sponsors and Collaborators
The University of Texas, Galveston
Investigators
Principal Investigator: David N. Herndon, MD University of Texas
  More Information

No publications provided by The University of Texas, Galveston

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00673309     History of Changes
Other Study ID Numbers: 00-454, P50 GM060338, R01 GM056687, SHC #8660
Study First Received: December 26, 2007
Last Updated: May 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas, Galveston:
burns

Additional relevant MeSH terms:
Clonidine
Dehydroepiandrosterone
Fenofibrate
Hormones
Insulin
Insulin, Globin Zinc
Itraconazole
Ketoconazole
Metformin
Oxandrolone
Pioglitazone
Propranolol
Testosterone
14-alpha Demethylase Inhibitors
Adjuvants, Immunologic
Adrenergic Agents
Adrenergic Agonists
Adrenergic Antagonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Antagonists
Anabolic Agents
Analgesics
Androgens
Anti-Arrhythmia Agents
Anti-Infective Agents
Antifungal Agents
Antihypertensive Agents
Antimetabolites
Autonomic Agents

ClinicalTrials.gov processed this record on November 25, 2014