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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 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: April 28, 2015
Last verified: April 2015
  Purpose

In a sham controlled double-blind trial we aim to establish the efficacy and safety of local application of laser therapy in patients with diabetes with onychomycosis and risk factors for diabetes related foot complications. Onychomycosis leads to thickened and distorted nails, which in turn leads 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 skiving 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.

Aim: The primary aim is to evaluate the efficacy of 4 sessions N-YAG 1064nM laser application on the one-year clinical and microbiological cure rate in a randomised, double-blinded sham-controlled design with blinded outcome assessment.

Study population: Patients with diabetes mellitus, with an increased risk for diabetic foot ulcers.

Intervention: local laser treatment from a podiatrist and the other group receives treatment according to a control procedure. The laser 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 cure is defined as a completely normal nail, or negative microbiological results in case minor abnormalities are present.

  • 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 and NailQol questionnaires are taken at baseline and week 52. 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: March 2015
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nd:YAG laser pulse therapy
Nd:YAG laser pulse therapy Patients are treated with laser session in week 0, 2, 4, and 12. The settings are; 1064 nm, spot size 3 mm, 20 J /cm2, 5 Hz, power 10 W, pulse duration 132 millisecond. A maximum of two sequential sessions (one session on the horizontal and one the vertical passing) will be applied to eliminate potential safety issues in those patients with a lack protective sensibility.
Device: Nd:YAG laser pulse therapy
Other Name: S30 PODYLAS
Sham Comparator: Sham
Sham treatment Patients are treated with a sham session in week 0, 2, 4, and 12. The study settings are similar to the laser except the laser beam. Because the patient is also blinded, they can't see the procedure. The sound and the beeps are audible similar to the laser treatment.
Device: Sham procedure
Sham procedure

Detailed Description:

Setting of the study: Hospital, outpatient departments (Foot clinic, Isala, Zwolle)

Inclusion criteria: Patients with clinical suspicion and microbiologic confirmation of onychomycosis , diagnosis of T1DM or T2DM, 18 years or older, at risk for diabetic foot ulcers defined by a modified Simm's classification score 1 or 2 with either neuropathy or PAD, nail involvement of at least 25% of the target nail.

Exclusion criteria: no microbiologic confirmation, Simms' classification score 3, the presence or history of diabetic foot ulcers, ischemic pain, ankle brachial index < 0.9, patients receiving dialysis, severe renal insufficiently (eGFR below 30 ml/min), a documented toe pressure below 50 mmHg, use of systemic or topical antifungal agents 3 months prior to inclusion, use of immunosuppressive drugs, presence of psoriasis, lichen planus, or other abnormalities that could result in clinically abnormal toenails, a history of epilepsy and insufficient knowledge of the Dutch language. Patients with a dark skin color (Fitzpatrick 4 and 5) are excluded since dark skin color is associated with dark nails, which theoretically leads to increased temperatures during laser application

  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 .

Exclusion Criteria:

  • Patients without the microbiological confirmation of fungal nail infection
  • Patients with an active or history of a diabetic foot ulcer
  • Patients who used systemic or topical anti fungal agents during the preceding 3 months
  • Patients with ischemic rest pain
  • Patients with ankle brachial index < 0.9
  • Patients with a documented toe pressure below 50 mmHg
  • Patients receiving dialysis, severe renal insufficiently (eGFR below 30 ml/min)
  • 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
Isala Diabetes Centre, Isala Hospital Recruiting
Zwolle, Netherlands, 8000 GK
Sponsors and Collaborators
Medical Research Foundation, The Netherlands
Investigators
Study Director: H.J.G. Bilo, professor MD Isala Diabetes Centre, Zwolle
Study Director: Nanne Kleefstra, MD PhD Isala Diabetes Centre,Zwolle
Principal Investigator: G.W.D. Landman, MD PhD Isala Diabetes Centre, Zwolle
Principal Investigator: Leonie Nijenhuis - Rosien, Bsc Isala Diabetes Centre, Zwolle
  More Information

No publications provided by Medical Research Foundation, The Netherlands

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: April 28, 2015
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on May 25, 2015