Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Laser Therapy for Onychomycosis in Patients Wih Diabetes at Risk for Diabetic Foot Complications
Brief Summary: 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.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Low Strength IDP-108 | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: High Strength IDP-108 | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: High Strength IDP-108 under occlusion | Arm Label: 4; Type: PLACEBO_COMPARATOR; Interventions: Drug: Vehicle | Intervention Type: DRUG; Name: Low Strength IDP-108; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: High Strength IDP-108; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: High Strength IDP-108 under occlusion; Assigned to Arm(s): 3 | Intervention Type: DRUG; Name: Vehicle; Assigned to Arm(s): 4
B: Arm Label: IDP-108; Type: EXPERIMENTAL; Interventions: Drug: IDP-108 | Arm Label: Vehicle; Type: PLACEBO_COMPARATOR; Interventions: Drug: Vehicle | Intervention Type: DRUG; Name: IDP-108; Assigned to Arm(s): IDP-108 | Intervention Type: DRUG; Name: Vehicle; Assigned to Arm(s): Vehicle
C: Arm Label: Nd:YAG laser pulse therapy; Type: EXPERIMENTAL; Interventions: Device: Nd:YAG laser pulse therapy | Arm Label: Sham; Type: SHAM_COMPARATOR; Interventions: Device: Sham procedure | Intervention Type: DEVICE; Name: Nd:YAG laser pulse therapy; Assigned to Arm(s): Nd:YAG laser pulse therapy | Intervention Type: DEVICE; Name: Sham procedure; Assigned to Arm(s): Sham
D: Arm Label: IDP-108; Type: EXPERIMENTAL; Interventions: Drug: IDP-108 | Arm Label: Vehicle; Type: PLACEBO_COMPARATOR; Interventions: Drug: Vehicle | Intervention Type: DRUG; Name: IDP-108; Assigned to Arm(s): IDP-108 | Intervention Type: DRUG; Name: Vehicle; Assigned to Arm(s): Vehicle

Answer: C