Assessment of Mechanisms of Improved Wound Healing
Information source: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Burns
Intervention: Collection of blood and tissues (Procedure); Stable Isotope Infusion study (Procedure); Radiology testing: DEXA, K+ counter, ultrasound, MRI (Procedure); 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 (Drug)
Phase: Phase 2/Phase 3
Sponsored by: The University of Texas Medical Branch, Galveston
Official(s) and/or principal investigator(s):
David N. Herndon, MD, Principal Investigator, Affiliation: University of Texas
The purpose of this study is to find ways to improve wound healing and decrease the negative
effects of trauma from burn injury.
Official title: Assessment of Mechanisms of Improved Wound Healing of Anabolic Agents and Diet in Severely Burned Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Decrease hypermetabolism as measured by stable isotope infusion study
Improved rate of wound healing
Incidence of morbidity and mortality
Incidence of sepsis
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.
Minimum age: N/A.
Maximum age: 90 Years.
- 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
- Known history of AIDS, AIDS-related complex, Human Immunodeficiency Virus
- History of cancer within 5 years
- Tuberculosis, arthritis, cirrhosis, hyperlipidemia, bone or endocrine diseases,
- Chronic glucocorticoid or non-steroidal anti-inflammatory drug therapy
Locations and Contacts
University of Texas Medical Branch, Galveston, Texas 77550, United States
Starting date: July 2002
Last updated: May 4, 2012