Bioburden Reduction of Diabetic Foot Ulcer

October 20, 2008 updated by: Nomir Medical Technologies

Noveon Laser Treatment to Effect Bioburden Reduction or Elimination in Diabetic Foot Ulcer: A Davice Performance Clinical Study

Study to see if a laser can get rid of bacateria called MRSA in your diabetic ulcer

Study Overview

Status

Unknown

Conditions

Diabetic Foot Ulcer

Intervention / Treatment

Device: Noveon laser

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Massachusetts
  - Waltham, Massachusetts, United States, 02452
    - Nomir Medical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

18 and older
Diabetic foot ulcer
MRSA positive

Exclusion Criteria:osteomylelitis pregnancy allery to e mycin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Decrease of Bioburden Effect In diabetic Foot Ulcer Time Frame: 28 days	28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nomir Medical Technologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

July 1, 2009

Study Completion (Anticipated)

November 1, 2009

Study Registration Dates

First Submitted

October 18, 2008

First Submitted That Met QC Criteria

October 20, 2008

First Posted (Estimate)

October 21, 2008

Study Record Updates

Last Update Posted (Estimate)