Laser Therapy for Onychomycosis in Patients Wih Diabetes at Risk for Diabetic Foot Complications (LASER-1)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by Medical Research Foundation, The Netherlands
Sponsor:
Information provided by (Responsible Party):
Gijs Landman, Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier:
NCT01996995
First received: November 22, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Onychomycosis
Device: Nd:YAG laser pulse therapy
Device: Sham procedure

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Medical Research Foundation, The Netherlands:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 64
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)
Arms Assigned Interventions
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
Sham procedure

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 or 3.

Exclusion Criteria:

  • Patients without the microbiological confirmation of fungal nail infection
  • Patients with an active diabetic foot ulcer
  • Patients who used systemic or topical anti fungal agents during the preceding 3 months
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01996995

Contacts
Contact: G.W.D. Landman, MD PhD 038-4242518

Locations
Netherlands
Diabeets Centre, Isala Hospital Not yet recruiting
Zwolle, Netherlands, 8000 GK
Sponsors and Collaborators
Medical Research Foundation, The Netherlands
Investigators
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
  More Information

No publications provided

Responsible Party: Gijs Landman, MD PhD, Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier: NCT01996995     History of Changes
Other Study ID Numbers: NL46084.075.13, NL46084.075.13
Study First Received: November 22, 2013
Last Updated: November 22, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Tinea
Onychomycosis
Diabetic Foot
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on July 31, 2014