Back to resultsBioburden Reduction of Diabetic Foot Ulcer
Primary Purpose
Diabetic Foot Ulcer
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Noveon laser
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer
Eligibility Criteria
Inclusion Criteria:
- 18 and older
- Diabetic foot ulcer
- MRSA positive
Exclusion Criteria:osteomylelitis pregnancy allery to e mycin
-
Sites / Locations
- Nomir Medical
Outcomes
Primary Outcome Measures
Decrease of Bioburden Effect In diabetic Foot Ulcer
Secondary Outcome Measures
Full Information
NCT ID
NCT00776854
First Posted
October 18, 2008
Last Updated
October 20, 2008
Sponsor
Nomir Medical Technologies
1. Study Identification
Unique Protocol Identification Number
NCT00776854
Brief Title
Bioburden Reduction of Diabetic Foot Ulcer
Official Title
Noveon Laser Treatment to Effect Bioburden Reduction or Elimination in Diabetic Foot Ulcer: A Davice Performance Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
November 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Nomir Medical Technologies
4. Oversight
5. Study Description
Brief Summary
Study to see if a laser can get rid of bacateria called MRSA in your diabetic ulcer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Noveon laser
Intervention Description
870 and 930nm wavelengths
Primary Outcome Measure Information:
Title
Decrease of Bioburden Effect In diabetic Foot Ulcer
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 and older
Diabetic foot ulcer
MRSA positive
Exclusion Criteria:osteomylelitis pregnancy allery to e mycin
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alan Robbins, MD
Phone
781-893-1000
Email
alanhrobbins@comcast.com
Facility Information:
Facility Name
Nomir Medical
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02452
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan robbins, MD
Phone
781-893-1000
12. IPD Sharing Statement
Learn more about this trial
Bioburden Reduction of Diabetic Foot Ulcer
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