NCT00310752CompletedPhase 1
Evaluation of DermStream(tm) - an Irrigation Product for Chronic Wound Management
EnzySurge1 site in 1 country11 target enrollmentStarted: March 1, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 11
- Locations
- 1
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- 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
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Not Applicable
Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic StenosisAortic Valve StenosisNCT01475799Direct Flow Medical, Inc.112
Withdrawn
Phase 1
Assessment of Systemically Administered Torisel Delivery to Brain Tumors by Intratumoral MicrodialysisBrain NeoplasmsNCT00949026Emory University
Not yet recruiting
Not Applicable
Evaluation of the Safety and Performance of the Hydrustent® Biodegradable Hydrogel Ureteral StentUrinary LithiasisNCT06719089Hydrumedical134
Completed
Not Applicable
Effectiveness and Safety Evaluation of Aqueduct -100 DeviceCervix Uteri DilationNCT02851953Aqueduct Medical Ltd41
Terminated
Not Applicable
To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH.Benign Prostatic HyperplasiaNCT02962674ProstaCare Singapore Pte. Ltd.49