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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-12-31

Brief Summary

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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

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Until now no expected or unexpected adverse events were occurred

Conditions

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Venous Insufficiency Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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DermaStream(tm) application and Streaming of Saline

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Arie Bass, Prof.

Role: PRINCIPAL_INVESTIGATOR

Asaf Harofe Medical Center

Locations

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Vascular Surgery Department, Asaf Harofe Medical Center

Zrifin, , Israel

Site Status

Countries

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Israel

Other Identifiers

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DS-1

Identifier Type: -

Identifier Source: org_study_id