aser therapy for onychomycosis in patients with diabetes at risk for diabetic foot complications A randomized, double blind controlled trial.
- Conditions
- 1001265310017528fungal nail infectiononychomycosis
- Registration Number
- NL-OMON41598
- Lead Sponsor
- Isala Klinieken
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 64
known diabetes (type 1 or 2)
over 18 years old
clinically suspicion with microbiologic confirmation of onychomycosis
at risk for diabetic foot ulcers defined by a Simm*s score 1 or 2
the nail has to be involved for at least 25% .
patients without microbiologic confirmation of fungal nail infection
patients with diabetic foot ulcers or foot ulcer in the medical history
patients who used systemic or topical antifungal agents during the preceding 3 months
patients with insufficient knowledge of the Dutch language to understand the requirements of the study
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.
patients with an ankle brachial index <0.9 and/or toepressure <50 mmHg
patients with ischaemic rest pain.
Patients with severe renal failure (eGFR<30 ml/min) or dialysis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Complete cure of the target nail</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Microbiological cure of the target nail<br /><br>• Complete clinical cure of the target nail<br /><br>• Markedly improved target nail<br /><br>• Complete clinical cure of all clinically infected toes<br /><br>• Nail severity index below 6 (in patients with a score >6 at study entry) of<br /><br>the target toe<br /><br>• Health related quality of life<br /><br>• Surface with healthy target nail / all clinically infected toes<br /><br>• Patients free of hyperkeratosis</p><br>