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

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.

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Key information

Conditions

Venous Insufficiency Cardiovascular Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Vascular Surgery Department, Asaf Harofe Medical Center

Zrifin, Israel

About this study

Until now no expected or unexpected adverse events were occurred

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DermaStream(tm) application and Streaming of Saline

Device

Sponsors and collaborators

Lead sponsor

EnzySurge

Industry

Registry information

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2006
First posted: Apr 4, 2006
Registry last updated: Aug 1, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed