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The Use of an Oral Mixture of Arginine, Glutamine and Beta-hydroxy-beta-methylbutyrate for Treatment of Pressure Ulcers

Primary Purpose

Pressure Ulcers Stage III, Pressure Ulcer, Stage IV

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
ABOUND
Sponsored by
Our Lady of Maryknoll Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pressure Ulcers Stage III

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Inpatients of medical and geriatric wards of OLMH and WTSH
  2. Aged 18 and older with stage III - IV lesions
  3. Patients fed orally or through feeding tubes were included

Exclusion Criteria:

  1. Patients with history of using the nutritional supplement (ABOUND) in previous three months
  2. Patients with cellulitis, wounds with purulent discharge or osteomyelitis or sepsis
  3. Patients requiring protein restriction
  4. Patients with poorly controlled diabetes mellitus (latest HbA1C > 8.5) (healing process may be affected
  5. Patients under palliative care

Sites / Locations

  • Our Lady of Maryknoll HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study group

Control group

Arm Description

The treatment group would be given 2 Sackets of an oral mixture of arginine, glutamine and HMB (ABOUND) every day for a maximum period of 4 weeks, either orally or via enteral feeding.

All patients would be assessed by a dietitian to ensure them receiving nutritional support of at least 30 kcal/kg/day and of at least 1.2 g/kg/day of protein regardless of feeding method. During the study period, vitamin C and zinc supplement would not be given.

Outcomes

Primary Outcome Measures

percentage change in pressure ulcer area
change in Pressure Ulcer Scale for Healing (PUSH)

Secondary Outcome Measures

number of hospital admissions
length of hospitalisation

Full Information

First Posted
January 28, 2017
Last Updated
January 30, 2017
Sponsor
Our Lady of Maryknoll Hospital
Collaborators
Wong Tai Sin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03038490
Brief Title
The Use of an Oral Mixture of Arginine, Glutamine and Beta-hydroxy-beta-methylbutyrate for Treatment of Pressure Ulcers
Official Title
The Use of an Oral Mixture of Arginine, Glutamine and Beta-hydroxy-beta-methylbutyrate for the Treatment of Pressure Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
September 30, 2019 (Anticipated)
Study Completion Date
March 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Our Lady of Maryknoll Hospital
Collaborators
Wong Tai Sin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To investigate whether an oral nutritional supplement of a mixture of arginine, glutamine and HMB for a maximum period of four weeks is more beneficial than the standard dietary approach to the healing of pressure ulcers, and to examine whether the use of it can reduce admissions and length of hospitalizations for these patients.
Detailed Description
All patients would be assessed by a dietitian to ensure them receiving nutritional support of at least 30 kcal/kg/day and of at least 1.2 g/kg/day of protein regardless of feeding method. During the study period, vitamin C and zinc supplement would not be given. Nutritional supplement other than that provided by the dietitian to meet the energy and protein requirement would not be given. The pressure ulcers would be cared according to the "Basic nursing standards for patient care: Wound dressing - Version 5" published by the Hospital Authority Head Office. The treatment group would also be given 2 Sackets of a mixture of arginine, glutamine and HMB (ABOUND) every day for a maximum period of 4 weeks, either orally or via enteral feeding.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcers Stage III, Pressure Ulcer, Stage IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
The treatment group would be given 2 Sackets of an oral mixture of arginine, glutamine and HMB (ABOUND) every day for a maximum period of 4 weeks, either orally or via enteral feeding.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
All patients would be assessed by a dietitian to ensure them receiving nutritional support of at least 30 kcal/kg/day and of at least 1.2 g/kg/day of protein regardless of feeding method. During the study period, vitamin C and zinc supplement would not be given.
Intervention Type
Dietary Supplement
Intervention Name(s)
ABOUND
Intervention Description
an oral mixture of arginine, glutamine and beta-hydroxy-beta-methylbutyrate
Primary Outcome Measure Information:
Title
percentage change in pressure ulcer area
Time Frame
4 weeks
Title
change in Pressure Ulcer Scale for Healing (PUSH)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
number of hospital admissions
Time Frame
six months
Title
length of hospitalisation
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inpatients of medical and geriatric wards of OLMH and WTSH Aged 18 and older with stage III - IV lesions Patients fed orally or through feeding tubes were included Exclusion Criteria: Patients with history of using the nutritional supplement (ABOUND) in previous three months Patients with cellulitis, wounds with purulent discharge or osteomyelitis or sepsis Patients requiring protein restriction Patients with poorly controlled diabetes mellitus (latest HbA1C > 8.5) (healing process may be affected Patients under palliative care
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kwok Man Lo, FHKAM (Med)
Email
lokm1@ha.org.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Ka Ying Doris Miu, FHKAM (Med)
Facility Information:
Facility Name
Our Lady of Maryknoll Hospital
City
Wong Tai Sin
ZIP/Postal Code
852
Country
Hong Kong
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19563522
Citation
Cereda E, Gini A, Pedrolli C, Vanotti A. Disease-specific, versus standard, nutritional support for the treatment of pressure ulcers in institutionalized older adults: a randomized controlled trial. J Am Geriatr Soc. 2009 Aug;57(8):1395-402. doi: 10.1111/j.1532-5415.2009.02351.x. Epub 2009 Jun 25.
Results Reference
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PubMed Identifier
24810310
Citation
Wong A, Chew A, Wang CM, Ong L, Zhang SH, Young S. The use of a specialised amino acid mixture for pressure ulcers: a placebo-controlled trial. J Wound Care. 2014 May;23(5):259-60, 262-4, 266-9. doi: 10.12968/jowc.2014.23.5.259.
Results Reference
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PubMed Identifier
25643304
Citation
Cereda E, Klersy C, Serioli M, Crespi A, D'Andrea F; OligoElement Sore Trial Study Group. A nutritional formula enriched with arginine, zinc, and antioxidants for the healing of pressure ulcers: a randomized trial. Ann Intern Med. 2015 Feb 3;162(3):167-74. doi: 10.7326/M14-0696. Erratum In: Ann Intern Med. 2015 Dec 15;163(12):964.
Results Reference
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The Use of an Oral Mixture of Arginine, Glutamine and Beta-hydroxy-beta-methylbutyrate for Treatment of Pressure Ulcers

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