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

This study has been completed.
Sponsor:
Information provided by:
EnzySurge
ClinicalTrials.gov Identifier:
NCT00310752
First received: April 3, 2006
Last updated: July 31, 2008
Last verified: July 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014