Diabetic Foot UlcerPhase 1NCT00776854
Bioburden Reduction of Diabetic Foot Ulcer
A Phase 1 study testing Noveon laser in people with Diabetic Foot Ulcer, run by Nomir Medical Technologies at 1 site in United States.
Trial summary
Study to see if a laser can get rid of bacateria called MRSA in your diabetic ulcer Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Noveon laser
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Nov 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 and older
- Diabetic foot ulcer
- MRSA positive
- Exclusion Criteria:osteomylelitis pregnancy allery to e mycin
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nomir Medical
Waltham, Massachusetts, 02452
Alan robbins, MD, 781-893-1000
About this study
Official title: Noveon Laser Treatment to Effect Bioburden Reduction or Elimination in Diabetic Foot Ulcer: A Davice Performance Clinical Study
Study to see if a laser can get rid of bacateria called MRSA in your diabetic ulcer
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Noveon laser
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noveon laserDevice
870 and 930nm wavelengths
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of Bioburden Effect In diabetic Foot Ulcer
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionJul 2009 (estimated)
- Study completionNov 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nomir Medical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776854
- Sponsor's protocol ID
- 12.001a
- Status last verified
- Oct 2008
- First submitted
- 18 Oct 2008
- Last updated
- 21 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noveon Laser Treatment to Effect Bioburden Reduction or Elimination in Diabetic Foot Ulcer: A Davice Performance Clinical Study
- ClinicalTrials.gov ID
- NCT00776854
- Acronym / sponsor ID
- 12.001a
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nomir Medical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Nov 2009 (estimated)
- First posted
- 21 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to see if a laser can get rid of bacateria called MRSA in your diabetic ulcer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 and older
- Diabetic foot ulcer
- MRSA positive
- Exclusion Criteria:osteomylelitis pregnancy allery to e mycin
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noveon laser870 and 930nm wavelengths | Device | – |
Primary outcome
Decrease of Bioburden Effect In diabetic Foot Ulcer
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2008.
Related trials for Diabetic Foot Ulcer
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Noveon laser in people with Diabetic Foot Ulcer, run by Nomir Medical Technologies at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alan Robbins, MD (781-893-1000, alanhrobbins@comcast.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease of Bioburden Effect In diabetic Foot Ulcer (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2008.