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Sponsors and Collaborators: |
Central Arkansas Veterans Healthcare System Abbott |
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Information provided by: | Central Arkansas Veterans Healthcare System |
ClinicalTrials.gov Identifier: | NCT00502372 |
The focus of this study is to look at the role of nutrition in the healing of pressure ulcers. The purpose of this study is to test whether the rate of healing of pressure ulcers is increased in those patients receiving a nutritional supplement of amino acids and the leucine metabolite, B-hydroxy-B-methylbutyrate is enhanced when compared to control patients receiving a supplement containing only one of the proteins in the experimental supplement
Condition | Intervention | Phase |
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Pressure Ulcers |
Behavioral: Nutritional Supplement/Amino acids and HMB |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Factorial Assignment, Efficacy Study |
Official Title: | Nutritional Effect of an Oral Supplement Enriched in Arginine, Glutamine and Leucine Metabolite B-Hydroxy B-Methylbutyrate |
Estimated Enrollment: | 76 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | March 2009 |
Patients who have pressure ulcers Stage II or greater will be randomized to receiving one of two nutritional supplements. One supplement contains arginine and the other contains both arginine,glutamine and leucine metabolites. Pressure ulcers will be measured at study entry and measured biweekly using a standardized tool (PUSH) until the trial is completed or the pressure ulcer has healed.
Inclusion criteria include:
Exclusion criteria include:
Ages Eligible for Study: | 21 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cathey L. Powers, MD | 501-257-5080 | powerscatheyl@uams.edu |
Contact: Ronni Chernoff, PhD | 501-257-5537 | chernoffronni@uams.edu |
United States, Arkansas | |
Central Arkansas Veterans Healthcare System | |
Little Rock, Arkansas, United States, 72205 |
Principal Investigator: | Cathey Powers, MD | Central Arkansas VA/UAMS College of Medicine |
Principal Investigator: | Ronni Chernoff, PhD | Central Arkansas VA/UAMS College of Medicine |
Study ID Numbers: | BJ93 |
Study First Received: | July 13, 2007 |
Last Updated: | July 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00502372 History of Changes |
Health Authority: | United States: Institutional Review Board |
Skin Diseases Ulcer Skin Ulcer Pressure Ulcer |
Skin Diseases Skin Ulcer Pressure Ulcer |