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Bioburden Reduction of Diabetic Foot Ulcer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00776854
Recruitment Status : Unknown
Verified October 2008 by Nomir Medical Technologies.
Recruitment status was:  Not yet recruiting
First Posted : October 21, 2008
Last Update Posted : October 21, 2008
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Device: Noveon laser Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Noveon Laser Treatment to Effect Bioburden Reduction or Elimination in Diabetic Foot Ulcer: A Davice Performance Clinical Study
Study Start Date : November 2008
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Device: Noveon laser
    870 and 930nm wavelengths

Outcome Measures

Primary Outcome Measures :
  1. Decrease of Bioburden Effect In diabetic Foot Ulcer [ Time Frame: 28 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 and older
  • Diabetic foot ulcer
  • MRSA positive

Exclusion Criteria:osteomylelitis pregnancy allery to e mycin

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776854


Contacts
Contact: Alan Robbins, MD 781-893-1000 alanhrobbins@comcast.com

Locations
United States, Massachusetts
Nomir Medical Not yet recruiting
Waltham, Massachusetts, United States, 02452
Contact: Alan robbins, MD    781-893-1000      
Sponsors and Collaborators
Nomir Medical Technologies
More Information

Responsible Party: Alan Robbin, M.D., Nomir Medical
ClinicalTrials.gov Identifier: NCT00776854     History of Changes
Other Study ID Numbers: 12.001a
First Posted: October 21, 2008    Key Record Dates
Last Update Posted: October 21, 2008
Last Verified: October 2008

Additional relevant MeSH terms:
Ulcer
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases