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

Sponsor
EnzySurge (Industry)
Overall Status
Completed
CT.gov ID
NCT00310752
Collaborator
(none)
11
Enrollment
1
Location
9
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: DermaStream(tm) application and Streaming of Saline
 Phase 1/Phase 2

Detailed Description

Until now no expected or unexpected adverse events were occurred

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Mar 1, 2006
Actual Primary Completion Date :
Dec 1, 2006
Actual Study Completion Date :
Dec 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vascular Surgery Department, Asaf Harofe Medical Center Zrifin Israel

    Sponsors and Collaborators

    • EnzySurge

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00310752
    Other Study ID Numbers:
    • DS-1
    First Posted:
    Apr 4, 2006
    Last Update Posted:
    Aug 1, 2008
    Last Verified:
    Jul 1, 2008
    Additional relevant MeSH terms:
    Venous Insufficiency

    Study Results

    No Results Posted as of Aug 1, 2008