NCT00673309

Assessment of Mechanisms of Improved Wound Healing

Assessment of Mechanisms of Improved Wound Healing of Anabolic Agents and Diet in Severely Burned Patients

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 644 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: All
• Age: 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Burns

Interventions

Type	Name	Description
PROCEDURE	Stable Isotope Infusion study	Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle)
DRUG	Insulin High Dose	Insulin IV administered continuously throughout hospitalization until wounds are 95% healed.
DRUG	oxandrolone	Oxandrolone given daily throughout hospitalization until 95% wound healing.
DRUG	Propranolol	Propranolol to be given daily throughout hospitalization until 95% wound healing.
DRUG	Growth Hormone	Recombinant Human Growth hormone to be administered daily until 95% wound healing.
DRUG	Insulin Low Dose	Insulin administered IV until 95% wound healing
DRUG	IGF-1/IGFBP-3	Insulin Like Growth Factor-1/Insulin like Growth Factor Binding Protein 3 administered until 95% wound healing
DRUG	Itraconazole	Itraconazole administered until 95% wound healing
DRUG	Growth Hormone and Propranolol	Growth Hormone and Propranolol given until 95% wound healing
DRUG	Oxandrolone and Propranolol	Oxandrolone and Propranolol
DRUG	Placebo or Control	Administration of Placebo or Control until 95% wound healing

Timeline

• Start date: 2000-07-01
• Primary completion: 2011-04-01
• Completion: 2013-04-01
• First posted: 2008-05-07
• Last updated: 2023-07-03
• Results posted: 2019-12-16

Locations

1 site across 1 country: United States