Effect of an Oral Supplement Enriched in Amino Acids and the Leucine Metabolite B-hydroxy B-methylbutyrate (HMB)

Pressure Ulcers Clinical Trial

Official title: Nutritional Effect of an Oral Supplement Enriched in Arginine, Glutamine and Leucine Metabolite B-Hydroxy B-Methylbutyrate

Status Terminated

Clinical Trial 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

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers

• NCT number: NCT00502372
• Study type: Interventional
• Source: Central Arkansas Veterans Healthcare System
• Status: Terminated
• Phase: Phase 1
• Start date: December 2008
• Completion date: January 2010