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

This study has been completed.

First Received: April 3, 2006 Last Updated: July 31, 2008 History of Changes

Sponsored by:	EnzySurge
Information provided by:	EnzySurge
ClinicalTrials.gov Identifier:	NCT00310752

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 I Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Study ID Numbers:	DS-1
Study First Received:	April 3, 2006
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00310752 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Study placed in the following topic categories:

Venous Insufficiency
Vascular Diseases
Diabetes Mellitus

Additional relevant MeSH terms:

Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009