To determine the efficacy and safety of laser therapy in diabetes patients with risk factors for developing diabetic foot complications.
ID
Source
Brief title
Condition
- Diabetic complications
- Fungal infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Complete cure of the target nail
Secondary outcome
• Microbiological cure of the target nail
• Complete clinical cure of the target nail
• Markedly improved target nail
• Complete clinical cure of all clinically infected toes
• Nail severity index below 6 (in patients with a score >6 at study entry) of
the target toe
• Health related quality of life
• Surface with healthy target nail / all clinically infected toes
• Patients free of hyperkeratosis
Background summary
Onychomycosis is an important problem for patients with diabetes. Nails with
fungal infection may become thick and distorted with 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 is often withheld due to
concerns for interactions with other drugs and side effects.
Study objective
To determine the efficacy and safety of laser therapy in diabetes patients with
risk factors for developing diabetic foot complications.
Study design
A randomized, double blind, controlled trial.
Intervention
One group receives treatment with a local laser treatment (Diode-pumped
solid-state laser) from a podiatrist and the other group receives treatment
according to a control procedure. The laser procedure will be blinded while
this procedure is performed as a sham procedure by a second podiatrist. The
patient will allso be blinded because the lower part of the patients body will
not be visible by using a shield.
The technical settings if the laser used during the study are; 1064 nm, spot
size 3 mm, 20 J /cm2, 5 Hz, power 10 W, pulse duration 132 millisecond.
Study burden and risks
The treatment consists of 4 sessions of 30 minutes laser therapy (week 0,2,4
and 12).
Patients will be evaluated (including studying research material from the
target nails) at week 30 and week 52.
We expect no serious side effects with minimal pain during the treatment.
dr. van Heesweg 11
Zwolle 8000 GK
NL
dr. van Heesweg 11
Zwolle 8000 GK
NL
Listed location countries
Age
Inclusion criteria
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% .
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46084.075.13 |