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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Alvin Wong, Changi General Hospital
ClinicalTrials.gov Identifier:
NCT01090076
First received: March 18, 2010
Last updated: June 14, 2013
Last verified: June 2013
Results First Received: February 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition: Pressure Ulcer
Intervention: Dietary Supplement: Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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

Reporting Groups
  Description
Abound 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 Placebo x 2 sachets/d

Participant Flow:   Overall Study
    Abound     Placebo  
STARTED     12     14  
COMPLETED     11     12  
NOT COMPLETED     1     2  
Death                 1                 1  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
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
Total Total of all reporting groups

Baseline Measures
    Abound     Placebo     Total  
Number of Participants  
[units: participants]
  12     14     26  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     1     4     5  
>=65 years     11     10     21  
Age  
[units: years]
Mean ± Standard Deviation
  78.5  ± 18.4     74.3  ± 12.4     75.4  ± 15.4  
Gender  
[units: participants]
     
Female     9     6     15  
Male     3     8     11  
Region of Enrollment  
[units: participants]
     
Singapore     12     14     26  



  Outcome Measures
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1.  Primary:   % Viable Tissue   [ Time Frame: weeks 1 to 2 ]

2.  Primary:   % Wound Area Week 1   [ Time Frame: week 0 to 1 ]

3.  Primary:   % Wound Area Week 2   [ Time Frame: Weeks 1 to 2 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Mr Alvin Wong
Organization: Changi General Hospital
phone: 68504627
e-mail: alvin_wong@cgh.com.sg


Publications:
Publications automatically indexed to this study:

Responsible Party: Alvin Wong, Changi General Hospital
ClinicalTrials.gov Identifier: NCT01090076     History of Changes
Other Study ID Numbers: ABOUND
Study First Received: March 18, 2010
Results First Received: February 13, 2013
Last Updated: June 14, 2013
Health Authority: Singapore: Health Sciences Authority
Singapore: Domain Specific Review Boards