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

Pressure Ulcers Stage III Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03038490
• Other study ID #: KW/FR-16-167(104-04)
• Status: Recruiting
• Phase: N/A
• First received: January 28, 2017
• Last updated: January 30, 2017
• Start date: December 1, 2016
• Est. completion date: March 31, 2020

Study information

• Verified date: January 2017
• Source: Our Lady of Maryknoll Hospital
• Contact: Kwok Man Lo, FHKAM (Med)
• Email: lokm1[@]ha.org.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 31, 2020
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcer, Stage IV
• Pressure Ulcers Stage III
• Ulcer

Intervention

Dietary Supplement:
• ABOUND
an oral mixture of arginine, glutamine and beta-hydroxy-beta-methylbutyrate

Locations

Country	Name	City	State
Hong Kong	Our Lady of Maryknoll Hospital	Wong Tai Sin

Sponsors (2)

Lead Sponsor	Collaborator
Our Lady of Maryknoll Hospital	Wong Tai Sin Hospital

Country where clinical trial is conducted

Hong Kong, 

References & 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage change in pressure ulcer area		4 weeks
Primary	change in Pressure Ulcer Scale for Healing (PUSH)		4 weeks
Secondary	number of hospital admissions		six months
Secondary	length of hospitalisation		six months