Assessment of Mechanisms of Improved Wound Healing - Full Text View

Sponsor:	The University of Texas, Galveston
Collaborator:	National Institutes of Health (NIH)
Information provided by (Responsible Party):	The University of Texas, Galveston
ClinicalTrials.gov Identifier:	NCT00673309

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:

MedlinePlus related topics: Anabolic Steroids Anxiety Burns Diabetes Medicines

Drug Information available for: Oxandrolone Prasterone Testosterone propionate Methyltestosterone Testosterone cypionate Testosterone Testosterone enanthate Propranolol hydrochloride Nandrolone decanoate Metformin Metformin hydrochloride Clonidine Clonidine hydrochloride Insulin human Somatropin Fenofibrate Ketoconazole Insulin-like growth factor I Itraconazole Fluconazole Pioglitazone Pioglitazone hydrochloride Exenatide

U.S. FDA Resources

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.

Ages Eligible for Study:	up to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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