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Laser therapy for onychomycosis in patients with diabetes at risk for foot complications: study protocol for a
Leonie Nijenhuis-Rosien1,2, Nanne Kleefstra3,4,5, Maurice J Wolfhagen6
1Diabetes Centre, Isala, Dr Spanjaardweg 11, 8025 BT, Zwolle, the Netherlands. l.nijenhuis@isala.nl.
Background:
In a sham-controlled double-blind trial, we aim to establish the efficacy and safety of the local application of laser therapy in patients with diabetes, onychomycosis and risk factors for diabetes-related foot complications. Onychomycosis leads to thickened and distorted nails, which in turn lead 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 shaving 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.
Methods/Design:
The primary aim is to evaluate the efficacy of four sessions of Nd:YAG 1064 nM laser application on the one-year clinical and microbiological cure rate in a randomized, double-blind, sham-controlled design with blinded outcome assessment. Mandatory inclusion criteria are diagnosis of diabetes, risk factors for developing foot ulcers defined as a modified Simm's classification score 1 or 2 and either neuropathy or PAD. A total of 64 patients are randomized to intervention or sham treatment performed by a podiatrist.
Discussion:
This study will be the first double-blind study that investigates the effects of local laser therapy on onychomycosis, specifically performed in patients with diabetes with additional risk factors for foot complications.
Trial Registration:
Clinical trials.gov as NCT01996995 , first received 22 November 2013.
Insights
This study investigates laser therapy for diabetic patients with onychomycosis and foot complication risks. It aims to determine laser treatment
Area of Science:
- Podiatry
- Dermatology
- Diabetology
Background:
- Onychomycosis (fungal nail infection) causes nail thickening, increasing pressure and risk of diabetes-related foot complications, especially with neuropathy or peripheral arterial disease (PAD).
- Current treatments for high-risk diabetic patients with onychomycosis are symptomatic, lacking effective local curative options.
- Systemic antifungal agents are often avoided due to potential side effects and drug interactions in diabetic patients.
Purpose of the Study:
- To evaluate the efficacy and safety of local laser therapy for onychomycosis in patients with diabetes and foot complication risk factors.
- To establish the one-year clinical and microbiological cure rates following laser treatment.
Main Methods:
- A randomized, double-blind, sham-controlled trial with blinded outcome assessment.
- Four sessions of Nd:YAG 1064 nM laser application were administered.
- Inclusion criteria: diabetes diagnosis, modified Simm's classification score 1 or 2, and either neuropathy or PAD. 64 patients were randomized.
Main Results:
- Study results are pending as this is a trial design abstract.
- The trial aims to provide the first double-blind evidence on local laser therapy for this specific patient group.
Conclusions:
- This research addresses a critical unmet need for effective local treatment of onychomycosis in high-risk diabetic patients.
- Findings are expected to inform clinical practice regarding laser therapy for preventing serious foot complications.
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