Laser Therapy for Onychomycosis in Patients Wih Diabetes at Risk for Diabetic Foot Complications (LASER-1)
Rationale: Onychomycosis is an important problem for patients with diabetes. Nails with fungal infection become thick and distorted with resulting pressure increase and the potential for serious complications like diabetic foot ulcers. As part of the diabetic foot care program, nails of patients at risk for developing ulcers and suspected onychomycosis are frequently skived. There is no effective local therapy that cures infection; systemic antifungal medication are often withheld due to concerns for interactions with other drugs and side effects.
Aim: To determine the efficacy of Nd:YAG laser therapy to treat onychomycosis in diabetes patients with risk factors for developing diabetic foot complications.
Setting: A randomized, double blind, controlled trial. Study population: Patients with diabetes mellitus, with an increased risk for diabetic ulcers.
Intervention: local laser treatment from a podiatrist and the other group receives treatment according to a control procedure. The later 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Laser Therapy for Onychomycosis in Patients Wih Diabetes at Risk for Diabetic Foot Complications|
- complete cure of the target nail [ Time Frame: outcome measured after 1 year ] [ Designated as safety issue: No ]after one year the clinical and microbiological cure rate of the target nail will be compared with usual care in the placebo group.
- Microbiological cure of the target nail [ Time Frame: outcome measured after 1 year ] [ Designated as safety issue: No ]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 [ Time Frame: outcome measured after 1 year ] [ Designated as safety issue: No ]Complete clinical cure is defined a normal nail (with only minor abnormalities; less than 5% of the surface area of the target nail at <1/4 distance of the distal nail edge without hyperkeratosis
- Markedly clinically improved target nail [ Time Frame: outcome measured after 1 year ] [ Designated as safety issue: No ]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 [ Time Frame: outcome measured after 1 year ] [ Designated as safety issue: No ]
- Complete clinical cure of all affected toes [ Time Frame: outcome measured after 1 year ] [ Designated as safety issue: No ]
- Change in quality of life [ Time Frame: outcome measured after 1 year ] [ Designated as safety issue: No ]WHO-5 Translated disease specific questionnaire; NailQol
- Change surface healthy target nail / all clinically infected toes patients free of hyperkeratosis [ Time Frame: outcome after 52 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: Nd:YAG laser pulse therapy
Nd:YAG laser pulse therapy 4 treatment sessions in 12 weeks
Device: Nd:YAG laser pulse therapy
Other Name: S30 PODYLAS
Sham Comparator: Sham
Sham treatment 4 sessions in 12 weeks
Device: Sham procedure
Setting of the study: Hospital, outpatient departments (Foot clinic, Isala, Zwolle)
Inclusion criteria: Patients are required to meet the following criteria; known diabetes, over 18 years old, clinically suspicion and microbiologic confirmation of onychomycosis, at risk for diabetic foot ulcers defined by a simm's score of 1 or higher.
Exclusion criteria: Patients without microbiologic confirmation of fungal nail infection, patients with diabetic foot ulcers, patients who used systemic or topical antifungal agents during the preceding 3 months and patients with insufficient knowledge of the Dutch language to understand the requirements of the study will be excluded. Patients who use immunosuppressive medication will also be excluded. Patients suffering from psoriasis with nail involvement, lichen planus, or other abnormalities that could result in clinically abnormal toenails will be excluded.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01996995
|Contact: G.W.D. Landman, MD PhD||038-4242518|
|Diabeets Centre, Isala Hospital||Not yet recruiting|
|Zwolle, Netherlands, 8000 GK|
|Study Director:||H.J.G. Bilo, professor MD||Diabetes Centre Zwolle|
|Study Director:||Nanne Kleefstra, MD PhD||Diabetes Centre Zwolle|
|Principal Investigator:||G.W.D. Landman, MD PhD||Diabetes Centre Zwolle|
|Principal Investigator:||Leonie Nijenhuis||Isala hospital Zwolle|