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

July 31, 2008 updated by: EnzySurge

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Until now no expected or unexpected adverse events were occurred

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Zrifin, Israel
        • Vascular Surgery Department, Asaf Harofe Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EnzySurge

Investigators

  • Principal Investigator: Arie Bass, Prof., Asaf Harofe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

April 3, 2006

First Submitted That Met QC Criteria

April 3, 2006

First Posted (Estimate)

April 4, 2006

Study Record Updates

Last Update Posted (Estimate)

August 1, 2008

Last Update Submitted That Met QC Criteria

July 31, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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