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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. Identifier: NCT00310752
Recruitment Status : Completed
First Posted : April 4, 2006
Last Update Posted : August 1, 2008
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Brief Summary:

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

Detailed Description:
Until now no expected or unexpected adverse events were occurred

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diabetic ulcer, OR Venous insufficiency ulcer
  • Age range: 18-80 years
  • Wound max. diameter range: 1.5 - 10 centimeters
  • Wound San Antonio assessment system: grade 1 and 2, stage A and B
  • Palpable pulses in the Posterior Tibial and the Dorsalis Pedis arteries
  • Ankle-Brachial Index > 0.7 by Doppler
  • Wound present for at least 6 weeks
  • Wound location: foot or calf, at a location where the device can be attached properly
  • Lack of purulent discharge from the wound.

Exclusion Criteria:

  • Hypoalbuminemia: Albumin < 2gr/dl
  • Right-side congestive heart failure with edema of legs: +2 or higher
  • Renal insufficiency: Cr > 2 mg/dl
  • Abnormal liver function: ALT or AST>300
  • Skin disorders adjacent to the wound, unrelated to the pathology of the wound
  • Non-cooperative patient

Information from the National Library of Medicine

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 identifier (NCT number): NCT00310752

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Vascular Surgery Department, Asaf Harofe Medical Center
Zrifin, Israel
Sponsors and Collaborators
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Principal Investigator: Arie Bass, Prof. Asaf Harofe Medical Center

Layout table for additonal information Identifier: NCT00310752     History of Changes
Other Study ID Numbers: DS-1
First Posted: April 4, 2006    Key Record Dates
Last Update Posted: August 1, 2008
Last Verified: July 2008
Additional relevant MeSH terms:
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Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases