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:	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 II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 Burns Diets

Drug Information available for: Oxandrolone Prasterone Insulin Somatropin Procetofen Ketoconazole Insulin-like growth factor I Fungarest Pioglitazone Pioglitazone hydrochloride Exenatide Mecasermin rinfabate Propranolol hydrochloride Propranolol Dehydroepiandrosterone sulfate Metformin Metformin hydrochloride Clonidine Clonidine hydrochloride Dexpropranolol Somatotropin

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 ]

Estimated Enrollment:	800
Study Start Date:	July 2002
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Experimental 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
3: Experimental 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.
4: Experimental 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.
5: Experimental 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.
6: Experimental 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.
7: Experimental 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.
8: Experimental 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.
10: Experimental 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
11: Experimental 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.
12: Placebo Comparator 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.
9: Experimental 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.
13: Experimental 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.

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

Contact: David N. Herndon, MD	409-770-6733	dherndon@utmb.edu
Contact: Deb Benjamin	409-770-6740	dbenjami@utmb.edu

United States, Texas
University of Texas Medical Branch	Recruiting
Galveston, Texas, United States, 77550
Contact: David N. Herndon, MD 409-770-6733 dherndon@utmb.edu
Contact: Deb Benjamin 409-770-6740 dbenjami@utmb.edu
Principal Investigator: David N. Herndon, MD

Responsible Party:	The University of Texas Medical Branch ( David Herndon, MD / Principal Investigator )
Study ID Numbers:	00-454, P50 GM060338, R01 GM056687, SHC #8660
Study First Received:	December 26, 2007
Last Updated:	December 9, 2009
ClinicalTrials.gov Identifier:	NCT00673309 History of Changes
Health Authority:	United States: Institutional Review Board