Text Size

Bioburden Reduction of Diabetic Foot Ulcer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Nomir Medical Technologies.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Nomir Medical Technologies
ClinicalTrials.gov Identifier:
NCT00776854
First received: October 18, 2008
Last updated: October 20, 2008
Last verified: October 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Diabetic Foot Ulcer
 Device: Noveon laser
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nomir Medical Technologies:

Primary Outcome Measures:
  • Decrease of Bioburden Effect In diabetic Foot Ulcer [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2008
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Noveon laser
    870 and 930nm wavelengths
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Alan Robbin, M.D., Nomir Medical
ClinicalTrials.gov Identifier: NCT00776854     History of Changes
Other Study ID Numbers: 12.001a
Study First Received: October 18, 2008
Last Updated: October 20, 2008
Health Authority: United Stated: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013