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

Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310752
• Other study ID #: DS-1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 3, 2006
• Last updated: July 31, 2008
• Start date: March 2006
• Est. completion date: December 2006

Study information

• Verified date: July 2008
• Source: EnzySurge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Until now no expected or unexpected adverse events were occurred

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Venous Insufficiency

Intervention

Device:
• DermaStream(tm) application and Streaming of Saline

Locations

Country	Name	City	State
Israel	Vascular Surgery Department, Asaf Harofe Medical Center	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
EnzySurge

Country where clinical trial is conducted

Israel,