Photodynamic Therapy and Topical Antifungal for Onychomycosis in Patients With Diabetes.

NCT06485050 | Active Not Recruiting

• 1 other identifier: 24/241-E
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

There are different therapeutic alternatives for onychomycosis. Systemic therapy is widely used due to its easy accessibility, low cost and high efficacy, but may be associated with systemic adverse events and drug-drug interactions, so its use in patients with diabetes, immunocompromised and frequently take more than five drugs is not recommended even though these individuals are at serious risk of fungal infection. On the other hand, laser therapy would be contraindicated in patients with neuropathy or peripheral vascular disease (diabetic foot patients) because of possible burns. Topical antifungals or lacquers are associated with a low risk of systemic adverse events and drug-drug interactions and would therefore be the most appropriate treatment for patients with diabetic foot. However, they require very long treatment periods, are generally applied daily for 12 months to allow the normal nail to grow and replace the regions damaged by the infection and have a lower cure rate. Because of all the above difficulties, there is a need to augment topical treatments in routine clinical practice with adjunctive therapies such as photodynamic therapy for the treatment of onychomycosis in patients with diabetes. The main aim of this study is to observe the effectiveness and safety of the combination of photodynamic therapy with the usual antifungal treatment in consultation in patients with diabetes. Secondary aims have been defined as follows: To determine whether 3 sessions of photodynamic therapy combined with topical therapy, over a period of 6 months, is sufficient to achieve clinical, mycological and complete cure of onychomycosis; And to analyse the influence of the type of onychomycosis (ODL, total dystrophic, superficial), the causal fungal agent (dermatophyte, mould or yeast) and the degree of severity of onychomycosis (through the OSI) on the response to treatment. Patients included in the study will be visited every 2 weeks during the first two months, applying photodynamic therapy during visits 2, 3 and 4. Subsequently, a check-up will be performed two weeks after the last application of photodynamic therapy and monthly visits for the remainder of the study. At each visit and at subsequent check-ups, the nail plate and peri- and subungual hyperkeratotic tissue will be debrided and reamed in order to improve the effects of the treatment.

Conditions

Dermatologic Disease; Onychomycosis of Toenail; Diabetic Foot; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Main outcome

  Number of participants with treatment-related adverse events as assessed by the effectiveness of the combination of photodynamic therapy with the usual antifungal treatment in the clinic in patients with diabetes, change from baseline in score on the Onychomycosis Severity Index (OSI), microbiological culture and polymerase chain reaction (PCR) at 6 months.

  6 months

Secondary Outcomes (3)

• Secondary outcome

  6 months

• Secondary outcome

  6 months

• Secondary outcome

  6 months

Study Arms (1)

Photodynamic therapy with ciclopirox 8%

EXPERIMENTAL

Combination Product: Photodynamic therapy

Interventions

Photodynamic therapy COMBINATION_PRODUCT

Application of red laser-photodynamic therapy using "Rapid Podia" Laser diode® (MEDENCY). The following protocol will be followed: 1) mechanical debridement of the nail, 2) disinfection of the nail with alcohol, 3) application of topical photosensitiser (Toluidine blue gel) for 5 minutes with the area covered, 5) application of 635 nm diode laser for 10 minutes. Daily application of ciclopirox 8% with ethyl acetate, ethanol (96%), ketosteryl alcohol, hydroxypropyl chitosan and purified water.

Photodynamic therapy with ciclopirox 8%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diabetes diagnosed with toenail onychomycosis with positive microbiological culture/PCR.
• Patients over 18 years of age.

You may not qualify if:

• Patients who have received topical or systemic antifungal treatment in the previous month.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

University podiatry clinic (Complutense University of Madrid)

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Skin Diseases; Diabetic Foot; Diabetes Mellitus

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Diabetic foot Unit

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: July 3, 2024
• Study Start: April 17, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)