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
Recruitment status was Not yet recruiting
Sponsor:
Nomir Medical Technologies
Information provided by:
Nomir Medical Technologies
ClinicalTrials.gov Identifier:
NCT00776854
First received: October 18, 2008
Last updated: October 20, 2008
Last verified: October 2008
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 18, 2008 | ||||
| Last Updated Date | October 20, 2008 | ||||
| Start Date ICMJE | November 2008 | ||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Decrease of Bioburden Effect In diabetic Foot Ulcer [ Time Frame: 28 days ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00776854 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Bioburden Reduction of Diabetic Foot Ulcer | ||||
| Official Title ICMJE | Noveon Laser Treatment to Effect Bioburden Reduction or Elimination in Diabetic Foot Ulcer: A Davice Performance Clinical Study | ||||
| Brief Summary | Study to see if a laser can get rid of bacateria called MRSA in your diabetic ulcer |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Diabetic Foot Ulcer | ||||
| Intervention ICMJE | Device: Noveon laser
870 and 930nm wavelengths |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | November 2009 | ||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:osteomylelitis pregnancy allery to e mycin - |
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00776854 | ||||
| Other Study ID Numbers ICMJE | 12.001a | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Alan Robbin, M.D., Nomir Medical | ||||
| Study Sponsor ICMJE | Nomir Medical Technologies | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Nomir Medical Technologies | ||||
| Verification Date | October 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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