CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 644 enrolled
Drug / intervention
Insulin High Dose +10 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00673309
NCT00673309Phase 3Completed
CompareCT.gov

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

The University of Texas Medical Branch, Galveston·interventional·Posted May 7, 2008·Updated Jul 3, 2023

In Brief

A Phase 3 clinical trial evaluating Stable Isotope Infusion study, Insulin High Dose, and 9 other interventions for Burns. Completed, enrolled 644 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBurns
CountriesUnited States
CollaboratorsNational Institute of General Medical Sciences (NIGMS)

Timeline

Phase 3CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 7, 2008
Enrollment StartJul 1, 2000
Primary CompletionApr 1, 2011
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 10.8 yearsPosted 18.2 years ago

Interventions

Stable Isotope Infusion studyprocedure

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)

Insulin High Dosedrug

Insulin IV administered continuously throughout hospitalization until wounds are 95% healed.

oxandrolonedrug

Oxandrolone given daily throughout hospitalization until 95% wound healing.

Propranololdrug

Propranolol to be given daily throughout hospitalization until 95% wound healing.

Growth Hormonedrug

Recombinant Human Growth hormone to be administered daily until 95% wound healing.

Insulin Low Dosedrug

Insulin administered IV until 95% wound healing

IGF-1/IGFBP-3drug

Insulin Like Growth Factor-1/Insulin like Growth Factor Binding Protein 3 administered until 95% wound healing

Itraconazoledrug

Itraconazole administered until 95% wound healing

Growth Hormone and Propranololdrug

Growth Hormone and Propranolol given until 95% wound healing

Oxandrolone and Propranololdrug

Oxandrolone and Propranolol

Placebo or Controldrug

Administration of Placebo or Control until 95% wound healing