Status:
COMPLETED
Evaluation of DermStream(tm) - an Irrigation Product for Chronic Wound Management
Lead Sponsor:
EnzySurge
Conditions:
Venous Insufficiency
Diabetes
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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 provide...
Detailed Description
Until now no expected or unexpected adverse events were occurred
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00310752
Start Date
March 1 2006
End Date
December 1 2006
Last Update
August 1 2008
Active Locations (1)
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1
Vascular Surgery Department, Asaf Harofe Medical Center
Zrifin, Israel