NCT03038490

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

2.8 years

First QC Date

January 28, 2017

Last Update Submit

January 30, 2017

Conditions

Pressure Ulcers Stage IIIPressure Ulcer, Stage IV

Outcome Measures

Primary Outcomes (2)

  • percentage change in pressure ulcer area

    4 weeks

  • change in Pressure Ulcer Scale for Healing (PUSH)

    4 weeks

Secondary Outcomes (2)

  • number of hospital admissions

    six months

  • length of hospitalisation

    six months

Study Arms (2)

Study group

EXPERIMENTAL

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.

Dietary Supplement: ABOUND

Control group

NO INTERVENTION

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.

Interventions

ABOUNDDIETARY_SUPPLEMENT

an oral mixture of arginine, glutamine and beta-hydroxy-beta-methylbutyrate

Study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Our Lady of Maryknoll Hospital

Wong Tai Sin, 852, Hong Kong

RECRUITING

Related Publications (3)

  • 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.

    PMID: 19563522BACKGROUND

  • 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.

    PMID: 24810310BACKGROUND

  • 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.

    PMID: 25643304BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Abound vaccine

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Kwok Man Lo, FHKAM (Med)

CONTACT

lokm1@ha.org.hk

Ka Ying Doris Miu, FHKAM (Med)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Consultant

Study Record Dates

First Submitted

January 28, 2017

First Posted

January 31, 2017

Study Start

December 1, 2016

Primary Completion

September 30, 2019

Study Completion

March 31, 2020

Last Updated

January 31, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)