Assessment of Mechanisms of Improved Wound Healing

NCT00673309 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 644

Last updated 2023-07-03

Study results available
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Summary

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

Conditions

  • Burns

Interventions

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

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH
  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • David N. Herndon, MD · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-07-31
Primary Completion
2011-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00673309 on ClinicalTrials.gov