Evaluation of DermStream(tm) - an Irrigation Product for Chronic Wound Management - Clinical Trial for Venous Insufficiency | NCT00310752

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

DermaStream(tm) application and Streaming of Saline

About this trial

This is an interventional treatment trial for Venous Insufficiency

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Vascular Surgery Department, Asaf Harofe Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00310752

First Posted

April 3, 2006

Last Updated

July 31, 2008

Sponsor

EnzySurge

1. Study Identification

Unique Protocol Identification Number

NCT00310752

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2008

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

December 2006 (Actual)

Study Completion Date

December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

EnzySurge

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Insufficiency, Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

DermaStream(tm) application and Streaming of Saline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arie Bass, Prof.

Organizational Affiliation

Asaf Harofe Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vascular Surgery Department, Asaf Harofe Medical Center

City

Zrifin

Country

Israel

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

Venous Insufficiency, Diabetes

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial