NCT00776854

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2008

Completed
11 days until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

October 21, 2008

Status Verified

October 1, 2008

Enrollment Period

8 months

First QC Date

October 18, 2008

Last Update Submit

October 20, 2008

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

  • Decrease of Bioburden Effect In diabetic Foot Ulcer

    28 days

Interventions

Noveon laserDEVICE

870 and 930nm wavelengths

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • and older
  • Diabetic foot ulcer
  • MRSA positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nomir Medical

Waltham, Massachusetts, 02452, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Central Study Contacts

Alan Robbins, MD

CONTACT

781-893-1000alanhrobbins@comcast.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 18, 2008

First Posted

October 21, 2008

Study Start

November 1, 2008

Primary Completion

July 1, 2009

Study Completion

November 1, 2009

Last Updated

October 21, 2008

Record last verified: 2008-10

Locations

US(1)