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Laser Therapy for Onychomycosis in Patients Wih Diabetes at Risk for Diabetic Foot Complications (LASER-1)

Primary Purpose

Onychomycosis

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Nd:YAG laser pulse therapy
Sham procedure
Sponsored by
Medical Research Foundation, The Netherlands
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 .

Exclusion Criteria:

  • 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
  • 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.

Sites / Locations

  • Isala Diabetes Centre, Isala Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Nd:YAG laser pulse therapy

Sham

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Onychomycosis severity index below 6 (in patients with scores >6 at study entry) of the target nail
Complete clinical cure of all affected toes
Change in quality of life
WHO-5 and NailQol questionnaires are taken at baseline and week 52. Translated disease specific questionnaire; NailQol
Change surface healthy target nail / all clinically infected toes patients free of hyperkeratosis

Full Information

First Posted
November 22, 2013
Last Updated
March 20, 2018
Sponsor
Medical Research Foundation, The Netherlands
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1. Study Identification

Unique Protocol Identification Number
NCT01996995
Brief Title
Laser Therapy for Onychomycosis in Patients Wih Diabetes at Risk for Diabetic Foot Complications
Acronym
LASER-1
Official Title
Laser Therapy for Onychomycosis in Patients Wih Diabetes at Risk for Diabetic Foot Complications
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
July 7, 2017 (Actual)
Study Completion Date
July 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Research Foundation, The Netherlands

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nd:YAG laser pulse therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Nd:YAG laser pulse therapy
Other Intervention Name(s)
S30 PODYLAS
Intervention Type
Device
Intervention Name(s)
Sham procedure
Intervention Description
Sham procedure
Primary Outcome Measure Information:
Title
complete cure of the target nail
Description
after one year the clinical and microbiological cure rate of the target nail will be compared with usual care in the placebo group.
Time Frame
outcome measured after 1 year
Secondary Outcome Measure Information:
Title
Microbiological cure of the target nail
Description
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.
Time Frame
outcome measured after 1 year
Title
Complete clinical cure of the target nail
Description
Complete cure is defined as a completely normal nail, or negative microbiological results in case minor abnormalities are present.
Time Frame
outcome measured after 1 year
Title
Markedly clinically improved target nail
Description
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.
Time Frame
outcome measured after 1 year
Title
Onychomycosis severity index below 6 (in patients with scores >6 at study entry) of the target nail
Time Frame
outcome measured after 1 year
Title
Complete clinical cure of all affected toes
Time Frame
outcome measured after 1 year
Title
Change in quality of life
Description
WHO-5 and NailQol questionnaires are taken at baseline and week 52. Translated disease specific questionnaire; NailQol
Time Frame
outcome measured after 1 year
Title
Change surface healthy target nail / all clinically infected toes patients free of hyperkeratosis
Time Frame
outcome after 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 . Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H.J.G. Bilo, professor MD
Organizational Affiliation
Isala Diabetes Centre, Zwolle
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nanne Kleefstra, MD PhD
Organizational Affiliation
Isala Diabetes Centre,Zwolle
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
G.W.D. Landman, MD PhD
Organizational Affiliation
Isala Diabetes Centre, Zwolle
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leonie Nijenhuis - Rosien, Bsc
Organizational Affiliation
Isala Diabetes Centre, Zwolle
Official's Role
Principal Investigator
Facility Information:
Facility Name
Isala Diabetes Centre, Isala Hospital
City
Zwolle
ZIP/Postal Code
8000 GK
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
25872590
Citation
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.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-0622-4

Learn more about this trial

Laser Therapy for Onychomycosis in Patients Wih Diabetes at Risk for Diabetic Foot Complications

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