NCT00310752

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 4, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

August 1, 2008

Status Verified

July 1, 2008

Enrollment Period

9 months

First QC Date

April 3, 2006

Last Update Submit

July 31, 2008

Conditions

Venous InsufficiencyDiabetes

Interventions

DermaStream(tm) application and Streaming of SalineDEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vascular Surgery Department, Asaf Harofe Medical Center

Zrifin, Israel

Location

MeSH Terms

Conditions

Venous InsufficiencyDiabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Arie Bass, Prof.

    Asaf Harofe Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 3, 2006

First Posted

April 4, 2006

Study Start

March 1, 2006

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

August 1, 2008

Record last verified: 2008-07

Locations

IL(1)