Assessment of Mechanisms of Improved Wound Healing

The University of Texas System (UT)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Burns

Treatments: Drug: Itraconazole; Drug: Placebo or Control; Drug: Growth Hormone; Drug: oxandrolone; Drug: Oxandrolone and Propranolol; Drug: Insulin Low Dose; Drug: IGF-1/IGFBP-3; Procedure: Stable Isotope Infusion study; Drug: Propranolol; Drug: Insulin High Dose; Drug: Growth Hormone and Propranolol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00673309

SHC #8660 (Other Grant/Funding Number)

00-454

P50GM060338 (U.S. NIH Grant/Contract)

R01GM056687 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 644 patients

Sex: All

Ages: Under 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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644 participants in 10 patient groups, including a placebo group

Growth Hormone

Experimental group

Description:

Growth Hormone administered daily until 95% wound healing. Stable Isotope Infusion Study with collection of blood and tissue

Treatment:

Procedure: Stable Isotope Infusion study

Drug: Growth Hormone

Insulin High Dose

Experimental group

Description:

Insulin IV administered continuously to 95% healing. Stable Isotope Infusion Study with collection of blood and tissue

Treatment:

Drug: Insulin High Dose

Procedure: Stable Isotope Infusion study

Oxandrolone

Experimental group

Description:

Oxandrolone administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue

Treatment:

Procedure: Stable Isotope Infusion study

Drug: oxandrolone

Propranolol

Experimental group

Description:

Propranolol administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue

Treatment:

Drug: Propranolol

Procedure: Stable Isotope Infusion study

IGF-1/IGFBP-3

Experimental group

Description:

IGF-1/IGFBP-3 will be administered until 95% wound healing

Treatment:

Drug: IGF-1/IGFBP-3

Procedure: Stable Isotope Infusion study

Insulin Low Dose

Experimental group

Description:

Insulin Low Dose will be administered until 95% wound healing.

Treatment:

Drug: Insulin Low Dose

Procedure: Stable Isotope Infusion study

Itraconazole

Experimental group

Description:

Itraconazole will be administered until 95% wound healing.

Treatment:

Procedure: Stable Isotope Infusion study

Drug: Itraconazole

Growth Hormone and Propranolol

Experimental group

Description:

Growth Hormone and Propranolol will be administered until 95% wound healing.

Treatment:

Drug: Growth Hormone and Propranolol

Procedure: Stable Isotope Infusion study

Oxandrolone and Propranolol

Experimental group

Description:

Oxandrolone and Propranolol will be administered until 95% wound healing

Treatment:

Procedure: Stable Isotope Infusion study

Drug: Oxandrolone and Propranolol

Control/Placebo

Placebo Comparator group

Description:

Placebo or Control will be administered until 95% wound healing

Treatment:

Drug: Placebo or Control

Procedure: Stable Isotope Infusion study