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Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00971048
First Posted: September 3, 2009
Last Update Posted: January 27, 2014
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.
Information provided by (Responsible Party):
Healthpoint
Results First Submitted: October 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions: Diabetic Foot Ulcers
Pressure Ulcers
Interventions: Device: HP828-101
Device: Hydrogel/Hydrocolloid

  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
Adults 18 years of age and older who had a DFU or PU on the foot that was a partial or full thickness wound

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
HP828-101 Treating DFU HP828-101 : Topical test article approximately the size of a nickel, applied once daily Treatment group had diabetic foot ulcers (DFU)
Standard of Care Treating DFU

For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel

Hydrogel for DFU (3M Tegaderm Hydrogel)

HP828-101 Treating PU HP828-101 : Topical test article approximately the size of a nickel, applied once daily Treatment group had pressure ulcers (PU)
Standard of Care Treating PU

For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel

Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)


Participant Flow:   Overall Study
    HP828-101 Treating DFU   Standard of Care Treating DFU   HP828-101 Treating PU   Standard of Care Treating PU
STARTED   30   33   12   13 
COMPLETED   29   31   11   11 
NOT COMPLETED   1   2   1   2 
Protocol Violation                1                2                0                1 
Adverse Event                0                0                1                0 
Physician Decision                0                0                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
HP828-101 Treating DFU HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
Standard of Care Treating DFU

For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel

Hydrogel for DFU(3M Tegaderm Hydrogel)

HP828-101 Treating PU HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
Standard of Care Treating PU

For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel

Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)

Total Total of all reporting groups

Baseline Measures
   HP828-101 Treating DFU   Standard of Care Treating DFU   HP828-101 Treating PU   Standard of Care Treating PU   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   33   12   13   88 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   18   17   7   7   49 
>=65 years   12   16   5   6   39 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.5  (13.5)   63.5  (10.4)   61.3  (12.6)   64.1  (17.0)   62.6  (12.7) 
Gender 
[Units: Participants]
         
Female   11   10   4   5   30 
Male   19   23   8   8   58 
Region of Enrollment 
[Units: Participants]
         
United States   30   33   12   13   88 


  Outcome Measures
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1.  Primary:   Adequate Management of the Wound Assessed by a Left Movement (Improvement) in the Modified Bates Jensen Wound Assessment Tool.   [ Time Frame: 22 - 29 days ]

2.  Secondary:   Number of Participants With Wound Closure by Day 22.   [ Time Frame: 22 days ]

3.  Secondary:   Pain Assessed by a 100-mm VAS Scale.   [ Time Frame: At every visit: Day 8, Day 15, Day 22, Day 29 ]

4.  Secondary:   Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT)   [ Time Frame: At every visit: Day 8, Day 15, Day 22, Day 29 ]


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jaime Dickerson, PhD
Organization: Smith & Nephew Biotherapeutics
phone: 817-302-3914
e-mail: jaime.dickerson@smith-nephew.com


Publications:

Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT00971048     History of Changes
Other Study ID Numbers: 828-101-09-013
First Submitted: August 27, 2009
First Posted: September 3, 2009
Results First Submitted: October 9, 2013
Results First Posted: January 27, 2014
Last Update Posted: January 27, 2014