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P400 for Stage II-IV Pressure Ulcers in Home and Extended Care (P400)

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.
ClinicalTrials.gov Identifier: NCT01139879
Recruitment Status : Completed
First Posted : June 9, 2010
Results First Posted : December 17, 2015
Last Update Posted : December 17, 2015
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pressure Ulcers
Intervention: Device: P400 mattress

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
P400

All patients will receive the P400 mattress

P400 mattress: The P400 mattress will be placed for a period of 12 weeks.


Participant Flow:   Overall Study
    P400
STARTED   10 
COMPLETED   10 
NOT COMPLETED   0 



  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.
Patients with multiple Stage II or at least one Stage III or IV pressure ulcer having less than or equal to 25% necrotic tissue present in the pressure ulcer at the time of placement.

Reporting Groups
  Description
P400

All patients will receive the P400 mattress

P400 mattress: The P400 mattress will be placed for a period of 12 weeks.


Baseline Measures
   P400 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.9  (21.5) 
Gender 
[Units: Participants]
 
Female   7 
Male   3 


  Outcome Measures

1.  Primary:   Change From Baseline in Ulcer Surface Area at Week 12   [ Time Frame: 12 Weeks ]

2.  Secondary:   Incidence of New Ulcers   [ Time Frame: 12 Weeks ]

3.  Secondary:   Healing Rate Per Week   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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
Small study with no comparative arm.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Randy Wolcott
Organization: Wolcott and Associates
phone: 806-793-8869
e-mail: lisa@randallwolcott.com



Responsible Party: Hill-Rom
ClinicalTrials.gov Identifier: NCT01139879     History of Changes
Other Study ID Numbers: CR-0092
First Submitted: June 7, 2010
First Posted: June 9, 2010
Results First Submitted: April 23, 2015
Results First Posted: December 17, 2015
Last Update Posted: December 17, 2015