Evaluation of DermStream(tm) - an Irrigation Product for Chronic Wound Management
|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: NCT00310752|
Recruitment Status : Completed
First Posted : April 4, 2006
Last Update Posted : August 1, 2008
The primary purpose of this study is to evaluate the safety of DermaStream(tm) in the management of chronic wounds.
Other goals of this study are to gain feedback from patients and healthcare providers on the ease of use (the ergonomic aspect) of the device, and to make a preliminary evaluation of the efficacy of DermaStream(tm) in chronic wound management.
|Condition or disease||Intervention/treatment||Phase|
|Venous Insufficiency Diabetes||Device: DermaStream(tm) application and Streaming of Saline||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310752
|Vascular Surgery Department, Asaf Harofe Medical Center|
|Principal Investigator:||Arie Bass, Prof.||Asaf Harofe Medical Center|