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VA never granted approval following suspension of enrollment.
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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enriched product, dietary supplement | Experimental | Subjects receiving enriched product compared to an unenriched product |
|
| 1 | Active Comparator | Subjects not receiving enriched product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional Supplement/Amino acids and HMB | Dietary Supplement | Subjects will be randomized to receive enriched dietary supplement (Juven) v arginine only (Argenaid) dietary supplement |
| Measure | Description | Time Frame |
|---|---|---|
| PUSH tool score | The PUSH tool measures the healing of a pressure ulcer by actually measuring the depth and width, in 2 dimensions, of a wound. A wound heals from the wound bed and closes from the inside to the outside if healthy pink granulation tissue can be seen. This tool contributes to the consistency of measurement of a healing wound. | 8 weeks or healing completed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cathey Powers, MD | Central Arkansas VA/UAMS College of Medicine | Principal Investigator |
| Ronni Chernoff, PhD | Central Arkansas VA/UAMS College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Arkansas Veterans Healthcare System | Little Rock | Arkansas | 72205 | United States |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D000596 | Amino Acids |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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|
| Juven | Dietary Supplement | comparison of Juven with arginine only product in wound healing |
|
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| D000602 |
| Amino Acids, Peptides, and Proteins |