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

NCT ID: NCT01996995

Last Updated: 2018-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-07-07

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

Conditions

Onychomycosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Nd:YAG laser pulse therapy

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.

Group Type: EXPERIMENTAL

Nd:YAG laser pulse therapy

Intervention Type: DEVICE

Sham

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.

Group Type: SHAM_COMPARATOR

Sham procedure

Intervention Type: DEVICE

Sham procedure

Interventions

Nd:YAG laser pulse therapy

Intervention Type: DEVICE

Sham procedure

Sham procedure

Intervention Type: DEVICE

Other Intervention Names

S30 PODYLAS

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Research Foundation, The Netherlands

OTHER

Sponsor Role: lead

Responsible Party

Henk Bilo, MD

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

H.J.G. Bilo, professor MD

Role: STUDY_DIRECTOR

Isala Diabetes Centre, Zwolle

Nanne Kleefstra, MD PhD

Role: STUDY_DIRECTOR

Isala Diabetes Centre,Zwolle

G.W.D. Landman, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Isala Diabetes Centre, Zwolle

Leonie Nijenhuis - Rosien, Bsc

Role: PRINCIPAL_INVESTIGATOR

Isala Diabetes Centre, Zwolle

Locations

Isala Diabetes Centre, Isala Hospital

Zwolle, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 25872590 (View on PubMed)

Study Documents

Document Type: Study Protocol

View Document

Other Identifiers

NL46084.075.13

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NL46084.075.13

Identifier Type: -

Identifier Source: org_study_id