OnychomycosisLASER-1NCT01996995
Laser Therapy for Onychomycosis in Patients Wih Diabetes at Risk for Diabetic Foot Complications
A study testing Nd:YAG laser pulse therapy in people with Onychomycosis, run by Medical Research Foundation, The Netherlands at 1 site in Netherlands.
Trial summary
In a sham controlled double-blind trial we aim to establish the efficacy and safety of local application of laser therapy in patients with diabetes with onychomycosis and risk factors for diabetes related foot complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Nd:YAG laser pulse therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2015to 7 Jul 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes
- Over 18 years old
- Clinically suspicion with microbiologic confirmation of onychomycosis
- Patient is at risk for diabetic foot ulcers defines as Simms score 1, 2 .
Who cannot join
- Patients without the microbiological confirmation of fungal nail infection
- Patients with an active or history of a diabetic foot ulcer
- Patients who used systemic or topical anti fungal agents during the preceding 3 months
- Patients with ischemic rest pain
- Patients with ankle brachial index < 0.9
- Patients with a documented toe pressure below 50 mmHg
Show all 11Show fewer
- Patients receiving dialysis, severe renal insufficiently (eGFR below 30 ml/min)
- Patients with an insufficient knowledge of the Dutch language to understand requirements of the study
- Patients with a dark skin color (Fitspatrick 4 and 5)
- Patients who uses immunosuppressive medication
- Patient suffering from nail psoriasis , lichen planus, or other abnormalities that could result in clinically abnormal toenails.
Trial locations and contacts
1 site in 1 country.
About this study
In a sham controlled double-blind trial we aim to establish the efficacy and safety of local application of laser therapy in patients with diabetes with onychomycosis and risk factors for diabetes related foot complications. Onychomycosis leads to thickened and distorted nails, which in turn leads to increased local pressure. The combination of onychomycosis and neuropathy or peripheral arterial disease (PAD) increases the risk of developing diabetes related foot complications. Usual care for high-risk patients with diabetes and onychomycosis is completely symptomatic with frequent skiving and clipping of the nails. No effective curative local therapies exist and systemic agents are often withheld due to concerns for side effects and interactions.
Aim: The primary aim is to evaluate the efficacy of 4 sessions N-YAG 1064nM laser application on the one-year clinical and microbiological cure rate in a randomised, double-blinded sham-controlled design with blinded outcome assessment.
Read more
Study population: Patients with diabetes mellitus, with an increased risk for diabetic foot ulcers.
Intervention: local laser treatment from a podiatrist and the other group receives treatment according to a control procedure. The laser procedure will be performed as a sham procedure by a second podiatrist.
Main study parameters/endpoints: The effect of 4 sessions of laser therapy on cure rate (clinical and microbiological) after one year.
Read the detailed description
Setting of the study: Hospital, outpatient departments (Foot clinic, Isala, Zwolle)
Inclusion criteria: Patients with clinical suspicion and microbiologic confirmation of onychomycosis , diagnosis of T1DM or T2DM, 18 years or older, at risk for diabetic foot ulcers defined by a modified Simm's classification score 1 or 2 with either neuropathy or PAD, nail involvement of at least 25% of the target nail.
Exclusion criteria: no microbiologic confirmation, Simms' classification score 3, the presence or history of diabetic foot ulcers, ischemic pain, ankle brachial index < 0.9, patients receiving dialysis, severe renal insufficiently (eGFR below 30 ml/min), a documented toe pressure below 50 mmHg, use of systemic or topical antifungal agents 3 months prior to inclusion, use of immunosuppressive drugs, presence of psoriasis, lichen planus, or other abnormalities that could result in clinically abnormal toenails, a history of epilepsy and insufficient knowledge of the Dutch language. Patients with a dark skin color (Fitzpatrick 4 and 5) are excluded since dark skin color is associated with dark nails, which theoretically leads to increased temperatures during laser application
- Conditions
- Onychomycosis
- Being tested
- Nd:YAG laser pulse therapy, Sham procedure
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nd:YAG laser pulse therapyDevice
Also called S30 PODYLAS
Sham procedureDevice
Sham procedure
| Study group | Role | What they receive |
|---|---|---|
| Nd:YAG laser pulse therapy | Experimental | Nd:YAG laser pulse therapy Patients are treated with laser session in week 0, 2, 4, and 12. The settings are; 1064 nm, spot size 3 mm, 20 J /cm2, 5 Hz, power 10 W, pulse duration 132 millisecond. A maximum of two sequential sessions (one session on the horizontal and one the vertical passing) will be applied to eliminate potential safety issues in those patients with a lack protective sensibility. Receives: Device: Nd:YAG laser pulse therapy |
| Sham | Sham comparator | Sham treatment Patients are treated with a sham session in week 0, 2, 4, and 12. The study settings are similar to the laser except the laser beam. Because the patient is also blinded, they can't see the procedure. The sound and the beeps are audible similar to the laser treatment. Receives: Device: Sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete cure of the target nail
after one year the clinical and microbiological cure rate of the target nail will be compared with usual care in the placebo group.
Measured: outcome measured after 1 year
Secondary outcomes (7)
Microbiological cure of the target nail
Patient with a negative microbiologic results of the target nail at week 52 will be regarded as having a microbiological cure. Patients with negative microbiological results at week 30 and positive microbiologic results at week 52 will be regarded as having a second infection. Patients with positive microbiologic results (with the same species) at week 30 and positive results at week 52 (the same species) will be regarded as treatment failure.
Measured: outcome measured after 1 year
Complete clinical cure of the target nail
Complete cure is defined as a completely normal nail, or negative microbiological results in case minor abnormalities are present.
Measured: outcome measured after 1 year
Markedly clinically improved target nail
A markedly improved nail is defined as a nail with less than 10% abnormalities without hyperkeratosis after 52 weeks in nails that were affected more than 10% of the surface area.
Measured: outcome measured after 1 year
Onychomycosis severity index below 6 (in patients with scores >6 at study entry) of the target nail
Measured: outcome measured after 1 year
Complete clinical cure of all affected toes
Measured: outcome measured after 1 year
Change in quality of life
WHO-5 and NailQol questionnaires are taken at baseline and week 52. Translated disease specific questionnaire; NailQol
Measured: outcome measured after 1 year
Change surface healthy target nail / all clinically infected toes patients free of hyperkeratosis
Measured: outcome after 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startMar 2015
- Primary completion7 Jul 2017
- Study completion7 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OnychomycosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Research Foundation, The Netherlands
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henk Bilo, MD, Medical Research Foundation, The Netherlands
- Investigators
- H.J.G. Bilo, professor MD, Study director, Isala Diabetes Centre, ZwolleNanne Kleefstra, MD PhD, Study director, Isala Diabetes Centre,ZwolleG.W.D. Landman, MD PhD, Principal investigator, Isala Diabetes Centre, ZwolleLeonie Nijenhuis - Rosien, Bsc, Principal investigator, Isala Diabetes Centre, Zwolle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996995
- Sponsor's protocol ID
- NL46084.075.13
- Other IDs
- NL46084.075.13
- Acronym
- LASER-1
- Status last verified
- Mar 2018
- First submitted
- 22 Nov 2013
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Nijenhuis-Rosien L, Kleefstra N, Wolfhagen MJ, Groenier KH, Bilo HJ, Landman GW. Laser therapy for onychomycosis in patients with diabetes at risk for foot complications: study protocol for a randomized, double-blind, controlled trial (LASER-1). Trials. 2015 Mar 22;16:108. doi: 10.1186/s13063-015-0622-4.
PubMed 25872590
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Therapy for Onychomycosis in Patients Wih Diabetes at Risk for Diabetic Foot Complications
- ClinicalTrials.gov ID
- NCT01996995
- Acronym / sponsor ID
- LASER-1 / NL46084.075.13
- Conditions
- Onychomycosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Medical Research Foundation, The NetherlandsUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- 7 Jul 2017 (actual)
- Study completion
- 7 Jul 2017 (actual)
- First posted
- 27 Nov 2013 (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.
In a sham controlled double-blind trial we aim to establish the efficacy and safety of local application of laser therapy in patients with diabetes with onychomycosis and risk factors for diabetes related foot complications. Onychomycosis leads to thickened and distorted nails, which in turn leads to increased local pressure. The combination of onychomycosis and neuropathy or peripheral arterial disease (PAD) increases the risk of developing diabetes related foot complications. Usual care for high-risk patients with diabetes and onychomycosis is completely symptomatic with frequent skiving and clipping of the nails. No effective curative local therapies exist and systemic agents are often withheld due to concerns for side effects and interactions.
Aim: The primary aim is to evaluate the efficacy of 4 sessions N-YAG 1064nM laser application on the one-year clinical and microbiological cure rate in a randomised, double-blinded sham-controlled design with blinded outcome assessment.
Study population: Patients with diabetes mellitus, with an increased risk for diabetic foot ulcers.
Intervention: local laser treatment from a podiatrist and the other group receives treatment according to a control procedure. The laser procedure will be performed as a sham procedure by a second podiatrist.
Main study parameters/endpoints: The effect of 4 sessions of laser therapy on cure rate (clinical and microbiological) after one year.
Detailed description
Setting of the study: Hospital, outpatient departments (Foot clinic, Isala, Zwolle)
Inclusion criteria: Patients with clinical suspicion and microbiologic confirmation of onychomycosis , diagnosis of T1DM or T2DM, 18 years or older, at risk for diabetic foot ulcers defined by a modified Simm's classification score 1 or 2 with either neuropathy or PAD, nail involvement of at least 25% of the target nail.
Exclusion criteria: no microbiologic confirmation, Simms' classification score 3, the presence or history of diabetic foot ulcers, ischemic pain, ankle brachial index < 0.9, patients receiving dialysis, severe renal insufficiently (eGFR below 30 ml/min), a documented toe pressure below 50 mmHg, use of systemic or topical antifungal agents 3 months prior to inclusion, use of immunosuppressive drugs, presence of psoriasis, lichen planus, or other abnormalities that could result in clinically abnormal toenails, a history of epilepsy and insufficient knowledge of the Dutch language. Patients with a dark skin color (Fitzpatrick 4 and 5) are excluded since dark skin color is associated with dark nails, which theoretically leads to increased temperatures during laser application
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nd:YAG laser pulse therapy | Experimental | Device: Nd:YAG laser pulse therapyNd:YAG laser pulse therapy Patients are treated with laser session in week 0, 2, 4, and 12. The settings are; 1064 nm, spot size 3 mm, 20 J /cm2, 5 Hz, power 10 W, pulse duration 132 millisecond. A maximum of two sequential sessions (one session on the horizontal and one the vertical passing) will be applied to eliminate potential safety issues in those patients with a lack protective sensibility. |
| Sham | Sham comparator | Device: Sham procedureSham treatment Patients are treated with a sham session in week 0, 2, 4, and 12. The study settings are similar to the laser except the laser beam. Because the patient is also blinded, they can't see the procedure. The sound and the beeps are audible similar to the laser treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diabetes
- Over 18 years old
- Clinically suspicion with microbiologic confirmation of onychomycosis
- Patient is at risk for diabetic foot ulcers defines as Simms score 1, 2 .
Key exclusion criteria (11 listed)
- Patients without the microbiological confirmation of fungal nail infection
- Patients with an active or history of a diabetic foot ulcer
- Patients who used systemic or topical anti fungal agents during the preceding 3 months
- Patients with ischemic rest pain
- Patients with ankle brachial index < 0.9
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 |
|---|---|---|
| Nd:YAG laser pulse therapyAlso: S30 PODYLAS | Device | Nd:YAG laser pulse therapy |
| Sham procedureSham procedure | Device | Sham |
Primary outcome
complete cure of the target nail
Time frame: outcome measured after 1 year
after one year the clinical and microbiological cure rate of the target nail will be compared with usual care in the placebo group.
7 secondary outcomes
Microbiological cure of the target nail
Time frame: outcome measured after 1 year
Complete clinical cure of the target nail
Time frame: outcome measured after 1 year
Markedly clinically improved target nail
Time frame: outcome measured after 1 year
Onychomycosis severity index below 6 (in patients with scores >6 at study entry) of the target nail
Time frame: outcome measured after 1 year
Complete clinical cure of all affected toes
Time frame: outcome measured after 1 year
Change in quality of life
Time frame: outcome measured after 1 year
Change surface healthy target nail / all clinically infected toes patients free of hyperkeratosis
Time frame: outcome after 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
- Derived from this study: PubMed 25872590Nijenhuis-Rosien L, Kleefstra N, Wolfhagen MJ, Groenier KH, Bilo HJ, Landman GW. Laser therapy for onychomycosis in patients with diabetes at risk for foot complications: study protocol for a randomized, double-blind, controlled trial (LASER-1). Trials. 2015 Mar 22;16:108. doi: 10.1186/s13063-015-0622-4.
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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.
H.J.G. Bilo, professor MD study director
Isala Diabetes Centre, Zwolle
Nanne Kleefstra, MD PhD study director
Isala Diabetes Centre,Zwolle
G.W.D. Landman, MD PhD principal investigator
Isala Diabetes Centre, Zwolle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nd:YAG laser pulse therapy in people with Onychomycosis, run by Medical Research Foundation, The Netherlands at 1 site in Netherlands.
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 4 inclusion and 11 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: finished, as of the sponsor's last update on 21 Mar 2018. 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 Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete cure of the target nail (time frame: outcome measured after 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01996995, which also lists 1 linked publication.
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 Mar 2018.