We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01090076
First Posted: March 19, 2010
Last Update Posted: June 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Abbott
Information provided by (Responsible Party):
Alvin Wong, Changi General Hospital
Results First Submitted: February 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
  Hide More Information

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 by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Alvin Wong, Changi General Hospital
ClinicalTrials.gov Identifier: NCT01090076     History of Changes
Other Study ID Numbers: ABOUND
First Submitted: March 18, 2010
First Posted: March 19, 2010
Results First Submitted: February 13, 2013
Results First Posted: June 6, 2013
Last Update Posted: June 24, 2013