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NCT00776854 Clinical Trial

Bioburden Reduction of Diabetic Foot Ulcer

Diabetic Foot Ulcer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00776854
Other study ID # 12.001a
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received October 18, 2008
Last updated October 20, 2008
Start date November 2008
Est. completion date November 2009

Study information
Verified date October 2008
Source Nomir Medical Technologies
Contact Alan Robbins, MD
Phone 781-893-1000
Email alanhrobbins@comcast.com
Is FDA regulated No
Health authority United Stated: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date November 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- 18 and older

- Diabetic foot ulcer

- MRSA positive

Exclusion Criteria:osteomylelitis pregnancy allery to e mycin

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Noveon laser
870 and 930nm wavelengths

Locations
Country Name City State
United States Nomir Medical Waltham Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Nomir Medical Technologies

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Decrease of Bioburden Effect In diabetic Foot Ulcer 28 days No
See also
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Completed NCT01657474 - Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers N/A
Active, not recruiting NCT00389636 - TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers N/A
Completed NCT01181440 - Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers Phase 3
Enrolling by invitation NCT05888259 - Plantar Pressure Distribution in Diabetic Foot Ulcer N/A
Completed NCT04054804 - Digital Foot Check by Using the D-Foot, a New Software
Not yet recruiting NCT05877378 - Efficacy of PICO Single-use System in Chronic Ulcers N/A
Recruiting NCT06037369 - The Short Message-based Customized Standardized N/A
Completed NCT03312595 - Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU) N/A
Recruiting NCT04564443 - A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot N/A