Nutritional Effect of an Oral Supplement Enriched in Arginine, Glutamine and Leucine Metabolite B-Hydroxy B-Methylbutyrate
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- PUSH tool score
Study Overview
Brief Summary
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
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with Stage II pressure ulcer or greater
- •Patients who consent to participate
- •Patients who can ingest the supplement either orally or per feeding tube
- •Patients who are 21 years of age or older
Exclusion Criteria
- •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 bolus tube feedings
Arms & Interventions
Enriched product, dietary supplement
Subjects receiving enriched product compared to an unenriched product
Intervention: Nutritional Supplement/Amino acids and HMB (Dietary Supplement)
Enriched product, dietary supplement
Subjects receiving enriched product compared to an unenriched product
Intervention: Juven (Dietary Supplement)
1
Subjects not receiving enriched product
Intervention: Nutritional Supplement/Amino acids and HMB (Dietary Supplement)
1
Subjects not receiving enriched product
Intervention: Juven (Dietary Supplement)
Outcomes
Primary Outcomes
PUSH tool score
Time Frame: 8 weeks or healing completed
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.
Secondary Outcomes
No secondary outcomes reported