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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01090076
Enrollment
26
Registered
2010-03-19
Start date
2010-04-30
Completion date
2011-09-30
Last updated
2013-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Ulcer

Keywords

Pressure Ulcer Wound, Specialized Amino Acid Mixture

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.

Detailed description

Pressure ulcers are defined as areas of localised damage to the skin, muscle or underlying tissue, caused by shear, friction or unrelieved pressure, usually over bony prominences. They are associated with many health conditions that cause prolonged bed rest, immobility, inactivity or poor sensation and can significantly contribute to morbidity and mortality, particularly in the aged population. International prevalence rates range widely from 4.6%- 83.6% due to methodological differences and classification systems. In Singapore, a study on the prevalence of pressure ulcers in 3 hospitals revealed a prevalence of 9% to 14%. Pressure ulcers often fail to heal in a timely and orderly manner, resulting in a chronic non-healing wound. Many intrinsic and extrinsic factors have been identified that can disrupt the wound healing processes of haemostasis, inflammation, proliferation, angiogenesis and remodelling. One of the factors gaining more interest for its impact on wound healing processes is nutritional status. Arginine is a semi-essential amino acid because even though the body normally makes enough of it, supplementation is sometimes needed during critical illness and severe trauma. There have been numerous research studies focusing on using arginine to enhance wound healing and pressure ulcer prevention. It is required for promotion of nitrogen balance, cell proliferation, T lymphocyte function and collagen accumulation. It also changes into nitric oxide, which is known for its vasodilatory and angiogenic properties. Glutamine is conditionally essential amino acid because it can be manufactured in the body, but under extreme physical stress the demand for glutamine exceeds the body's ability to make it. Adequate amounts of glutamine are generally obtained through diet alone because the body is also able to make glutamine on its own. Certain medical conditions, including injuries, surgery, infections, and prolonged stress, can deplete glutamine levels. Since glutamine plays a key role in the immune system, a deficiency in this nutrient can significantly slow the healing process. Beta-hydroxy-Beta methylbutyrate (HMB) is a metabolite of leucine, an essential amino acid. HMB supplementation was associated with increased muscle mass accretion. HMB appears to assert its effect via inhibiting muscle proteolysis and modulating protein turnover. Recently, arginine has been found to accelerate wound healing in combination with HMB and glutamine. It was shown that healthy subjects who are supplemented orally with arginine had a significant rise in plasma arginine and ornithine levels that led to enhanced rate of collagen synthesis. In another recent study, a HMB/Arginine/Lysine mixture increased protein turnover in elderly patients over a year long period. However, there is no known randomised controlled trial done on patients with chronic hard to heal wounds in acute healthcare settings. AIM To compare pressure ulcer healing rates in patients supplemented with a commercial HMB/Arginine/Lysine mixture (Abound) and standard high protein, high energy iso-nitrogenous medical nutritional supplements versus patients supplemented with only standard high protein, high energy iso-nitrogenous medical nutritional supplements. OUTCOME INDICATORS * Percentage change in wound size (length, depth, area) * Percentage change in proportion of viable wound tissue (Refer to wound data collection for details) The study will take on a comparative, randomised controlled trial design.

Interventions

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

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

Sponsors

Abbott
CollaboratorINDUSTRY
Changi General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
% Viable Tissueweeks 1 to 2-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.
% Wound Area Week 1week 0 to 1Percentage change in wound area after week 1
% Wound Area Week 2Weeks 1 to 2Percentage change in wound area after week 2

Countries

Singapore

Participant flow

Recruitment details

26 subjects were recruited between June 2010 to June 2011 and all subjects were inpatients of Changi General Hospital. 23 subjects completed the trial.

Pre-assignment details

Subjects were randomly assigned to either arm after an initial assessment by PI and wound nurses. There is no wash out period for this trial

Participants by arm

ArmCount
Abound
Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : 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
12
Placebo
Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : 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
14
Total26

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath11
Overall StudyWithdrawal by Subject01

Baseline characteristics

CharacteristicPlaceboAboundTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
10 Participants11 Participants21 Participants
Age, Categorical
Between 18 and 65 years
4 Participants1 Participants5 Participants
Age Continuous74.3 years
STANDARD_DEVIATION 12.4
78.5 years
STANDARD_DEVIATION 18.4
75.4 years
STANDARD_DEVIATION 15.4
Region of Enrollment
Singapore
14 participants12 participants26 participants
Sex: Female, Male
Female
6 Participants9 Participants15 Participants
Sex: Female, Male
Male
8 Participants3 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 120 / 14
serious
Total, serious adverse events
0 / 120 / 14

Outcome results

Primary

% 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.

Time frame: weeks 1 to 2

ArmMeasureValue (MEAN)Dispersion
Abound% Viable Tissue43.06 Percentage of viable tissueStandard Error 8.43
Placebo% Viable Tissue25.94 Percentage of viable tissueStandard Error 6.68
p-value: 0.023t-test, 2 sided
Primary

% Wound Area Week 1

Percentage change in wound area after week 1

Time frame: week 0 to 1

ArmMeasureValue (MEAN)Dispersion
Abound% Wound Area Week 1-15.37 percent changeStandard Error 7.64
Placebo% Wound Area Week 1-13.68 percent changeStandard Error 7.68
p-value: 0.877t-test, 2 sided
Primary

% Wound Area Week 2

Percentage change in wound area after week 2

Time frame: Weeks 1 to 2

ArmMeasureValue (MEAN)Dispersion
Abound% Wound Area Week 2-27.50 Percentage changeStandard Error 10.11
Placebo% Wound Area Week 2-37.54 Percentage changeStandard Error 7.33
p-value: 0.44t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026