Pressure UlcerNCT01090076
The Use of Specialised Amino Acid Mixture in Pressure Ulcer Wound Healing Rates- A Placebo Controlled Trial
A study testing Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) in people with Pressure Ulcer, run by Changi General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteSingapore
- Study dates
- Apr 2010to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Specialised Amino Acid Mixture in Pressure Ulcer Wound Healing Rates-A Placebo Controlled Trial
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.
Read the 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.
- Conditions
- Pressure Ulcer
- Being tested
- Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB)
- Keywords
- Pressure Ulcer Wound, Specialized Amino Acid Mixture
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Abound | Experimental | Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) Receives: 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 Receives: Dietary Supplement: Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
% 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.
Measured: weeks 1 to 2
% Wound Area Week 1
Percentage change in wound area after week 1
Measured: week 0 to 1
% Wound Area Week 2
Percentage change in wound area after week 2
Measured: Weeks 1 to 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Alvin Wong, Changi General Hospital
- Investigators
- Alvin Wong, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090076
- Sponsor's protocol ID
- ABOUND
- Status last verified
- Jun 2013
- First submitted
- 18 Mar 2010
- Last updated
- 24 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 19164608Smith 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.
PubMed 15665304Eley 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.
PubMed 17609254Stechmiller JK, Childress B, Cowan L. Arginine supplementation and wound healing. Nutr Clin Pract. 2005 Feb;20(1):52-61. doi: 10.1177/011542650502000152.
PubMed 16207646Benati 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.
PubMed 11431045Desneves 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.
PubMed 16297506Wong 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.
PubMed 24810310
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Specialised Amino Acid Mixture in Pressure Ulcer Wound Healing Rates-A Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT01090076
- Acronym / sponsor ID
- ABOUND
- Conditions
- Pressure Ulcer
- Keywords
- Pressure Ulcer Wound, Specialized Amino Acid Mixture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Apr 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 19 Mar 2010 (estimated)
- Results
- Posted 6 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abound | Experimental | Dietary Supplement: Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB)Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) |
| Placebo | Placebo comparator | Dietary Supplement: Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB)Placebo comparator that contains none of the active ingredients |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Dietary supplement | Abound, Placebo |
Primary outcome
% Viable Tissue
Time frame: weeks 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 1
Time frame: week 0 to 1
Percentage change in wound area after week 1
% Wound Area Week 2
Time frame: Weeks 1 to 2
Percentage change in wound area after week 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19164608Baier 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.
- Background: PubMed 15665304Smith 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.
- Background: PubMed 17609254Eley 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.
- Background: PubMed 16207646Stechmiller JK, Childress B, Cowan L. Arginine supplementation and wound healing. Nutr Clin Pract. 2005 Feb;20(1):52-61. doi: 10.1177/011542650502000152.
- Background: PubMed 11431045Benati 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.
- Background: PubMed 16297506Desneves 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.
- Derived from this study: PubMed 24810310Wong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alvin Wong principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) in people with Pressure Ulcer, run by Changi General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% Viable Tissue (time frame: weeks 1 to 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01090076, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2013.