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A Post Marketing Clinical Study Utilizing DermaStream and Saline in Venous Ulcers

NCT01129986 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2013-09-04

No results posted yet for this study

Summary

An open-label, prospective, controlled, two-step approach, post-marketing clinical study, applying DermaStream with saline streaming, in conjunction with a sustained multi-compression wrap, on healthy individuals and on patients with a venous stasis ulcer of the lower extremity.

Conditions

  • Venous Stasis Ulcers

Interventions

DEVICE

DermaStream

Five treatment days. On each day DermaStream application for up to 4 hours of saline streaming.

Sponsors & Collaborators

  • EnzySurge

    lead INDUSTRY

Principal Investigators

  • Daniel Ihnat · S.A.L.S.A, Tucson Arizona

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-07-31
Completion
2011-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01129986 on ClinicalTrials.gov