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Evaluation of DermStream(tm) - an Irrigation Product for Chronic Wound Management

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00310752
First Posted: April 4, 2006
Last Update Posted: August 1, 2008
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:
EnzySurge
  Purpose

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 Intervention Phase
Venous Insufficiency Diabetes Device: DermaStream(tm) application and Streaming of Saline Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by EnzySurge:

Enrollment: 11
Study Start Date: March 2006
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:
Until now no expected or unexpected adverse events were occurred
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00310752


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

ClinicalTrials.gov Identifier: NCT00310752     History of Changes
Other Study ID Numbers: DS-1
First Submitted: April 3, 2006
First Posted: April 4, 2006
Last Update Posted: August 1, 2008
Last Verified: July 2008

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases