The Use of Specialised Amino Acid Mixture in Pressure Ulcer Wound Healing Rates- A Placebo Controlled Trial

NCT01090076 | Completed Results

• 1 other identifier: ABOUND
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This research aims to address the gap in the studies done and test the effects of a commercial mixture of 7 g of Arginine, 7 g Glutamine and 1.2 g HMB\* twice a day on hard to heal pressure ulcers in an Asian patient cohort in an acute healthcare setting.

Conditions

Pressure Ulcer

Keywords

Pressure Ulcer Wound; Specialized Amino Acid Mixture

Outcome Measures

Primary Outcomes (3)

• % Viable Tissue

  -Percentage viable tissue after 2 weeks The estimated change in proportion of viable and non-viable tissue was determined using area derived from planimetry via acetate tracings. The description of viable tissue was taken to mean granulating (red) or epithelising (pink) tissue, and non-viable tissue were taken as necrotic (black) or sloughy (green or yellow) tissue.

  weeks 1 to 2

• % Wound Area Week 1

  Percentage change in wound area after week 1

  week 0 to 1

• % Wound Area Week 2

  Percentage change in wound area after week 2

  Weeks 1 to 2

Study Arms (2)

Abound

EXPERIMENTAL

Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB)

Dietary Supplement: Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB)

Placebo

PLACEBO COMPARATOR

Placebo comparator that contains none of the active ingredients

Dietary Supplement: Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB)

Interventions

Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) DIETARY_SUPPLEMENT

Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d

Abound; Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with pressure ulcers stage II, III or IV, non-healing admitted to Changi General Hospital for \> 2 weeks
• Patients who are able to attend outpatient follow-up appointments for dietary and wound review

You may not qualify if:

• Age \< 21 years old
• Poorly controlled Diabetic Patients (HbA1c \>7.0%)
• Patients on Total Parenteral Nutrition
• Patients in MICU/ SICU/ Medically Unstable/ Palliative Care
• Patients with severe Sepsis
• Length of stay \< 2 weeks
• Patients who require fluid restriction \< 1L/d
• Patients on any other wound healing supplements (e.g. Zinc, Vitamin A and Vitamin C)
• Patients with lower extremity ulcers with untreated peripheral vascular disease
• Patients with deep tissue infection and/or requiring debridement of necrotic or sloughy tissue
• Patients unable to attend outpatient follow-up appointments
• Patients who cannot tolerate oral intake \> 70% EER and/or Fluid intake 30ml/kg BW
• Patients who require protein restriction
• Patients who are unable to give consent (absence of next-of-kin)

Sponsors & Collaborators

• Changi General Hospital: lead
• Abbott: collaborator

Study Sites (1)

Changi General Hospital

Singapore, Singapore, 529889, Singapore

Location

Related Publications (7)

• Baier S, Johannsen D, Abumrad N, Rathmacher JA, Nissen S, Flakoll P. Year-long changes in protein metabolism in elderly men and women supplemented with a nutrition cocktail of beta-hydroxy-beta-methylbutyrate (HMB), L-arginine, and L-lysine. JPEN J Parenter Enteral Nutr. 2009 Jan-Feb;33(1):71-82. doi: 10.1177/0148607108322403.

  PMID: 19164608 BACKGROUND

• Smith HJ, Mukerji P, Tisdale MJ. Attenuation of proteasome-induced proteolysis in skeletal muscle by beta-hydroxy-beta-methylbutyrate in cancer-induced muscle loss. Cancer Res. 2005 Jan 1;65(1):277-83.

  PMID: 15665304 BACKGROUND

• Eley HL, Russell ST, Baxter JH, Mukerji P, Tisdale MJ. Signaling pathways initiated by beta-hydroxy-beta-methylbutyrate to attenuate the depression of protein synthesis in skeletal muscle in response to cachectic stimuli. Am J Physiol Endocrinol Metab. 2007 Oct;293(4):E923-31. doi: 10.1152/ajpendo.00314.2007. Epub 2007 Jul 3.

  PMID: 17609254 BACKGROUND

• Stechmiller JK, Childress B, Cowan L. Arginine supplementation and wound healing. Nutr Clin Pract. 2005 Feb;20(1):52-61. doi: 10.1177/011542650502000152.

  PMID: 16207646 BACKGROUND

• Benati G, Delvecchio S, Cilla D, Pedone V. Impact on pressure ulcer healing of an arginine-enriched nutritional solution in patients with severe cognitive impairment. Arch Gerontol Geriatr Suppl. 2001;7:43-7. doi: 10.1016/s0167-4943(01)00120-0. No abstract available.

  PMID: 11431045 BACKGROUND

• Desneves KJ, Todorovic BE, Cassar A, Crowe TC. Treatment with supplementary arginine, vitamin C and zinc in patients with pressure ulcers: a randomised controlled trial. Clin Nutr. 2005 Dec;24(6):979-87. doi: 10.1016/j.clnu.2005.06.011. Epub 2005 Nov 15.

  PMID: 16297506 BACKGROUND

• 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: 24810310 DERIVED

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Arginine; Glutamine

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential; Amino Acids, Neutral

Limitations and Caveats

Limitations of trial include small sample size and it was difficult to standardise wound care regimen as the pressure ulcers were of different stages and locations.

Results Point of Contact

• Title: Mr Alvin Wong
• Organization: Changi General Hospital

alvin_wong@cgh.com.sg

68504627

Study Officials

• Alvin Wong

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Dietitian

Study Record Dates

• First Submitted: March 18, 2010
• First Posted: March 19, 2010
• Study Start: April 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 24, 2013
• Results First Posted: June 6, 2013

Record last verified: 2013-06

Locations

SG (1)