Effect of an Oral Supplement Enriched in Amino Acids and the Leucine Metabolite B-Hydroxy B-Methylbutyrate (HMB) - NCT00502372-72205 (Clinical Trial 177684)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy177684.aspx
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| City: |
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Little Rock |
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State:
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AR |
| Zip Code: |
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72205 |
| Conditions: |
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Pressure Ulcers |
| Purpose: |
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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
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| Study summary: |
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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:
- Stage II or greater pressure ulcer
- Patient consent
- Patients who can drink supplement or receive it by tube
- Patients who are 21 years old or greater
Exclusion criteria include:
- Patients with infected wounds
- Patients with cellulitis, sepsis or osteomyelitis
- Patients with end-organ failure
- Patients with poorly controlled diabetes mellitus (HbA1C>10)
- Patients who cannot tolerate oral or tube feeding |
| Criteria: |
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Inclusion Criteria:
1. Patients with Stage II pressure ulcer or greater
2. Patients who consent to participate
3. Patients who can ingest the supplement either orally or per feeding tube
4. Patients who are 21 years of age or older
Exclusion Criteria:
1. Patients with infected wounds
2. Patients with cellulitis, sepsis or osteomyelitis
3. Patients with end-organ failure
4. Patients with poorly controlled diabetes mellitus (HbA1C>10)
5. Patients who cannot tolerate oral or bolus tube feedings |
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| Study is available at: |
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Central Arkansas Veterans Healthcare System Little Rock, AR 72205 United States
Primary Contact: Cathey L. Powers, MD Email: powerscatheyl@uams.edu Phone: 501-257-5080 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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