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

NCT01996995 | Completed

• 1 other identifier: NL46084.075.13
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Onychomycosis

Outcome Measures

Primary Outcomes (1)

• 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.

  outcome measured after 1 year

Secondary Outcomes (7)

• Microbiological cure of the target nail

  outcome measured after 1 year

• Complete clinical cure of the target nail

  outcome measured after 1 year

• Markedly clinically improved target nail

  outcome measured after 1 year

• Onychomycosis severity index below 6 (in patients with scores >6 at study entry) of the target nail

  outcome measured after 1 year

• Complete clinical cure of all affected toes

  outcome measured after 1 year

Study Arms (2)

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.

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.

Device: Sham procedure

Interventions

Nd:YAG laser pulse therapy DEVICE

Also known as: S30 PODYLAS

Nd:YAG laser pulse therapy

Sham procedure DEVICE

Sham procedure

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical Research Foundation, The Netherlands: lead

Study Sites (1)

Isala Diabetes Centre, Isala Hospital

Zwolle, 8000 GK, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 25872590 DERIVED

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• H.J.G. Bilo, professor MD

  Isala Diabetes Centre, Zwolle

  STUDY DIRECTOR

• Nanne Kleefstra, MD PhD

  Isala Diabetes Centre,Zwolle

  STUDY DIRECTOR

• G.W.D. Landman, MD PhD

  Isala Diabetes Centre, Zwolle

  PRINCIPAL INVESTIGATOR

• Leonie Nijenhuis - Rosien, Bsc

  Isala Diabetes Centre, Zwolle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: November 27, 2013
• Study Start: March 1, 2015
• Primary Completion: July 7, 2017
• Study Completion: July 7, 2017
• Last Updated: March 21, 2018

Record last verified: 2018-03

Locations

NL (1)