Assessment of Mechanisms of Improved Wound Healing

NCT00673309 | Completed Phase 2 Results DMC

• 4 other identifiers: 00-454P50GM060338R01GM056687SHC #8660
• Study Type: interventional
• Target: 644
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

burns

Outcome Measures

Primary Outcomes (1)

• Decrease Hypermetabolism as Measured by Stable Isotope Infusion Study

  At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are.

  Admission to burn unit to 95% wound healing

Secondary Outcomes (3)

• Improved Rate of Wound Healing

  Admission to burn unit to 95% wound healing

• Incidence of Morbidity and Mortality

  Admission to burn unit to discharge

• Incidence of Sepsis

  Admission to burn unit to 95% wound healing

Study Arms (10)

Growth Hormone

EXPERIMENTAL

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

Procedure: Stable Isotope Infusion study; Drug: Growth Hormone

Insulin High Dose

EXPERIMENTAL

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

Procedure: Stable Isotope Infusion study; Drug: Insulin High Dose

Oxandrolone

EXPERIMENTAL

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

Procedure: Stable Isotope Infusion study; Drug: oxandrolone

Propranolol

EXPERIMENTAL

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

Procedure: Stable Isotope Infusion study; Drug: Propranolol

IGF-1/IGFBP-3

EXPERIMENTAL

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

Procedure: Stable Isotope Infusion study; Drug: IGF-1/IGFBP-3

Insulin Low Dose

EXPERIMENTAL

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

Procedure: Stable Isotope Infusion study; Drug: Insulin Low Dose

Itraconazole

EXPERIMENTAL

Itraconazole will be administered until 95% wound healing.

Procedure: Stable Isotope Infusion study; Drug: Itraconazole

Growth Hormone and Propranolol

EXPERIMENTAL

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

Procedure: Stable Isotope Infusion study; Drug: Growth Hormone and Propranolol

Oxandrolone and Propranolol

EXPERIMENTAL

Oxandrolone and Propranolol will be administered until 95% wound healing

Procedure: Stable Isotope Infusion study; Drug: Oxandrolone and Propranolol

Control/Placebo

PLACEBO COMPARATOR

Placebo or Control will be administered until 95% wound healing

Procedure: Stable Isotope Infusion study; Drug: Placebo or Control

Interventions

Stable Isotope Infusion study PROCEDURE

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)

Control/Placebo; Growth Hormone; Growth Hormone and Propranolol; IGF-1/IGFBP-3; Insulin High Dose; Insulin Low Dose; Itraconazole; Oxandrolone; Oxandrolone and Propranolol; Propranolol

Insulin High Dose DRUG

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

Also known as: Regular Insulin

Insulin High Dose

oxandrolone DRUG

Oxandrolone given daily throughout hospitalization until 95% wound healing.

Also known as: nandrolone

Oxandrolone

Propranolol DRUG

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

Propranolol

Growth Hormone DRUG

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

Also known as: GH, rhGH, recombinant human Growth Hormone

Growth Hormone

Insulin Low Dose DRUG

Insulin administered IV until 95% wound healing

Also known as: Insulin

Insulin Low Dose

IGF-1/IGFBP-3 DRUG

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

Also known as: Insulin Like Growth Factor

IGF-1/IGFBP-3

Itraconazole DRUG

Itraconazole administered until 95% wound healing

Itraconazole

Growth Hormone and Propranolol DRUG

Growth Hormone and Propranolol given until 95% wound healing

Also known as: GH and Propranolol

Growth Hormone and Propranolol

Oxandrolone and Propranolol DRUG

Oxandrolone and Propranolol

Oxandrolone and Propranolol

Placebo or Control DRUG

Administration of Placebo or Control until 95% wound healing

Control/Placebo

Eligibility Criteria

• Age: Up to 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77550, United States

Location

Related Publications (9)

• Zinter MS, Markovic D, Asaro LA, Nadkarni VM, McQuillen PS, Sinha P, Matthay MA, Jeschke MG, Agus MSD, Sapru A; CAF-PINT Investigators of the PALISI Network. Tight Glycemic Control, Inflammation, and the ICU: Evidence for Heterogeneous Treatment Effects in Two Randomized Controlled Trials. Am J Respir Crit Care Med. 2023 Apr 1;207(7):945-949. doi: 10.1164/rccm.202210-1988LE. No abstract available.

  PMID: 36656551 DERIVED

• Kraft R, Herndon DN, Finnerty CC, Shahrokhi S, Jeschke MG. Occurrence of multiorgan dysfunction in pediatric burn patients: incidence and clinical outcome. Ann Surg. 2014 Feb;259(2):381-7. doi: 10.1097/SLA.0b013e31828c4d04.

  PMID: 23511841 DERIVED

• Jeschke MG, Williams FN, Finnerty CC, Rodriguez NA, Kulp GA, Ferrando A, Norbury WB, Suman OE, Kraft R, Branski LK, Al-mousawi AM, Herndon DN. The effect of ketoconazole on post-burn inflammation, hypermetabolism and clinical outcomes. PLoS One. 2012;7(5):e35465. doi: 10.1371/journal.pone.0035465. Epub 2012 May 11.

  PMID: 22606232 DERIVED

• Jeschke MG, Gauglitz GG, Kulp GA, Finnerty CC, Williams FN, Kraft R, Suman OE, Mlcak RP, Herndon DN. Long-term persistance of the pathophysiologic response to severe burn injury. PLoS One. 2011;6(7):e21245. doi: 10.1371/journal.pone.0021245. Epub 2011 Jul 18.

  PMID: 21789167 DERIVED

• Jeschke MG, Kraft R, Emdad F, Kulp GA, Williams FN, Herndon DN. Glucose control in severely thermally injured pediatric patients: what glucose range should be the target? Ann Surg. 2010 Sep;252(3):521-7; discussion 527-8. doi: 10.1097/SLA.0b013e3181f2774c.

  PMID: 20739853 DERIVED

• Mecott GA, Herndon DN, Kulp GA, Brooks NC, Al-Mousawi AM, Kraft R, Rivero HG, Williams FN, Branski LK, Jeschke MG. The use of exenatide in severely burned pediatric patients. Crit Care. 2010;14(4):R153. doi: 10.1186/cc9222. Epub 2010 Aug 11.

  PMID: 20701787 DERIVED

• Jeschke MG, Kulp GA, Kraft R, Finnerty CC, Mlcak R, Lee JO, Herndon DN. Intensive insulin therapy in severely burned pediatric patients: a prospective randomized trial. Am J Respir Crit Care Med. 2010 Aug 1;182(3):351-9. doi: 10.1164/rccm.201002-0190OC. Epub 2010 Apr 15.

  PMID: 20395554 DERIVED

• Gauglitz GG, Herndon DN, Kulp GA, Meyer WJ 3rd, Jeschke MG. Abnormal insulin sensitivity persists up to three years in pediatric patients post-burn. J Clin Endocrinol Metab. 2009 May;94(5):1656-64. doi: 10.1210/jc.2008-1947. Epub 2009 Feb 24.

  PMID: 19240154 DERIVED

• Jeschke MG, Chinkes DL, Finnerty CC, Kulp G, Suman OE, Norbury WB, Branski LK, Gauglitz GG, Mlcak RP, Herndon DN. Pathophysiologic response to severe burn injury. Ann Surg. 2008 Sep;248(3):387-401. doi: 10.1097/SLA.0b013e3181856241.

  PMID: 18791359 DERIVED

MeSH Terms

Conditions

Burns

Interventions

Insulin; Oxandrolone; Nandrolone; Propranolol; Growth Hormone; Insulin-Like Peptides; Itraconazole

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrenes; Estranes; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pituitary Hormones, Anterior; Pituitary Hormones; Intercellular Signaling Peptides and Proteins; Proteins; Biological Factors; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Limitations and Caveats

At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are.

Results Point of Contact

• Title: Tina Mack-Moshay- ClinicalTrials.gov Administrator
• Organization: University of Texas Medical Branch

tlmackmo@utmb.edu

409-266-6917

Study Officials

• David N. Herndon, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: May 7, 2008
• Study Start: July 1, 2000
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2013
• Last Updated: July 3, 2023
• Results First Posted: December 16, 2019

Record last verified: 2023-06

Locations

US (1)