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

Phase 1

Terminated

• Conditions: Pressure Ulcers
• Interventions: Dietary Supplement: Nutritional Supplement/Amino acids and HMB; Dietary Supplement: Juven

• Registration Number: NCT00502372
• Lead Sponsor: Central Arkansas Veterans Healthcare System

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 Timeline

• Study First Submitted: 2007-07-13
• Study First Submitted QC: 2007-07-13
• Study First Posted: 2007-07-17
• Study Start: 2008-12
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-14
• Last Update Posted: 2015-12-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enriched product, dietary supplement	Nutritional Supplement/Amino acids and HMB	Subjects receiving enriched product compared to an unenriched product
Enriched product, dietary supplement	Juven	Subjects receiving enriched product compared to an unenriched product
1	Juven	Subjects not receiving enriched product
1	Nutritional Supplement/Amino acids and HMB	Subjects not receiving enriched product

Primary Outcome Measures

Name	Time	Method
PUSH tool score	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.

Trial Locations

Locations (1)

Central Arkansas Veterans Healthcare System; 🇺🇸 Little Rock, Arkansas, United States