Evaluation of DermStream(tm) - an Irrigation Product for Chronic Wound Management
Phase 1
Completed
- Conditions
- Venous InsufficiencyDiabetes
- Registration Number
- NCT00310752
- Lead Sponsor
- EnzySurge
- 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.
- Detailed Description
Until now no expected or unexpected adverse events were occurred
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vascular Surgery Department, Asaf Harofe Medical Center
🇮🇱Zrifin, Israel