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

EnzySurge11 enrolled

Overview

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.

Until now no expected or unexpected adverse events were occurred

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Venous Insufficiency Diabetes

Interventions

DermaStream(tm) application and Streaming of SalineDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Vascular Surgery Department, Asaf Harofe Medical Center

Zrifin, Israel

Data from ClinicalTrials.gov

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