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Effectiveness of dermaPACE™ Device and Standard Treatment Compared to Standard Treatment Alone for Diabetic Foot Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SANUWAVE, Inc.
ClinicalTrials.gov Identifier:
NCT00536744
First received: September 26, 2007
Last updated: March 7, 2014
Last verified: March 2014
Results First Received: March 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Diabetic Foot Ulcers
Interventions: Device: acoustical pulse energy (extracorporeal shockwave)
Other: Sham

  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
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
dermaPACE Application + Standard of Care

dermaPACE application + standard of care

dermaPACE: dermaPACE + Standard of care wound dressing.

Non-energized (Inactive) Application + Standard of Care

Non-energized (inactive) application + standard of care

Sham: Sham treatment + Standard of care wound dressing.


Participant Flow:   Overall Study
    dermaPACE Application + Standard of Care   Non-energized (Inactive) Application + Standard of Care
STARTED   107   99 
COMPLETED   78   71 
NOT COMPLETED   29   28 
Adverse Event                13                10 
Death                2                1 
Physician Decision                3                1 
Lost to Follow-up                3                5 
Withdrawal by Subject                7                8 
PI tried alternative treatment                1                3 



  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
dermaPACE Application + Standard of Care dermaPACE: dermaPACE + Standard of care wound dressing.
Non-energized (Inactive) Application + Standard of Care Sham: Sham treatment (non-energized, inactive device) + Standard of care wound dressing.
Total Total of all reporting groups

Baseline Measures
   dermaPACE Application + Standard of Care   Non-energized (Inactive) Application + Standard of Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 107   99   206 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.4  (10.4)   56.2  (9.4)   58.3  (9.9) 
Gender 
[Units: Participants]
     
Female   24   16   40 
Male   83   83   166 
Region of Enrollment 
[Units: Participants]
     
United States   103   94   197 
Germany   2   3   5 
United Kingdom   2   2   4 


  Outcome Measures

1.  Primary:   The Primary Variable for Effectiveness of the dermaPACE Device Will be Assessed by Comparing the Incidence of Complete Wound Closure of the dermaPACE and Control Groups 12 Weeks Post Initial Application.   [ Time Frame: 12 weeks post initial application ]

2.  Secondary:   Time to Wound Closure, Wound Closure Area and Volume Between Active and Control 12 Weeks Post Initial Application, Subject Pain Assessment Between Active and Control 24 Weeks Post Initial Application   [ Time Frame: 12 weeks post initial application and 24 weeks post initial application ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
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  More Information
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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: Dr. Daniel Jorgensen, MD
Organization: SANUWAVE, Inc.
phone: 678-578-0116
e-mail: daniel.jorgensen@sanuwave.com



Responsible Party: SANUWAVE, Inc.
ClinicalTrials.gov Identifier: NCT00536744     History of Changes
Other Study ID Numbers: SAN07-DERM01
Study First Received: September 26, 2007
Results First Received: March 7, 2014
Last Updated: March 7, 2014
Health Authority: United States: Food and Drug Administration