Medico-economical Assessment of Telemedicine During Chronic Diabetes-related Foot Wound Management (AIRPEDIA)Mar 2013
The aim of the study is to assess the cost-effectiveness of telemedicine in the care of chronic diabetic foot ulcers.
An Open,Single-centre Pilot Study of Efficacy and Safety of Topical MOB015B in the Treatment of Distal Subungual Onychomycosis (DSO)Mar 2013
Assess efficacy and safety of topical MOB015B, applied daily during 48 weeks, in adults with fungal nail infection.
Multicenter, randomized, open clinical trial comparing three sessions of methyl-aminolevulinate 16% (Metvix®) photodynamic therapy versus a group without photodynamic therapy to treat onychomycosis.Jan 2013
To determine the effectiveness of methyl aminolevulinate (MAL) 16% photodinamic therapy (PDT) (3 sessiones using 37 j/cm2) to treat onychomycosis)
Assessment of the Efficacy and Safety of a New Wound Dressing in the Local Treatment of Diabetic Foot UlcersOct 2012
The main purpose of this trial is to demonstrate that the new dressing is more effective than the current dressing in the local treatment of chronic foot ulcers in diabetic patients.
Telemedicine Follow-up in Primary Health Care for Diabetes-related Foot Ulcers (DiaFOTo)Oct 2012
This study will investigate whether telemedicine follow-up care for people with diabetes-related foot ulcers in municipal primary health care in collaboration with specialist health care is an equivalent alternative to traditional outpatient clinical follow-up in specialist health care (noninferiority trial) in relation to healing time.
Randomized, open-label, controlled study on the efficacy of Ciclopoli® (ciclopirox 8% nail lacquer) versus Loceryl® (amorolfine 5% nail lacquer) on the culture conversion to negative in patients with onychomycosis.Oct 2011
T evaluate the conversion to negative of culture of treatment with Ciclopoli® vs Loceryl® .
Oral BBR-012 in the Treatment of Diabetic Foot Ulcers, Proof of Concept StudyApr 2011
The aim of this Clinical Proof of Principle study is to evaluate the effect of BBR-012 on the healing of complicated diabetic foot ulcers.
A Randomised, Double-Blind, Repeat-Dose, Placebo-Controlled Phase IIa Proof of Concept Study to Investigate the Safety and Efficacy of Oral BBR-012 in Combination With Standard Medical Care in Diabetic Patients With Complicated Skin Ulceration on the Foot (Diabetic Foot Ulcer)Mar 2011
To compare the rate of healing of DFUs, measured as percent reduction in wound area per week, after 28-days treatment with BBR-012 or placebo, in combination with standard medical therapy.
An open, multi-centre trial comparing the efficacy and safety of two different treatment regimens of topical MOB015 treatment of distal subungual onychomycosis (DSO)Sep 2010
The primary objective of this trial is to compare efficacy and safety of two different treatment regimens of topical MOB015 in adults with DSO at 12 months. The primary efficacy variable is the proportion of patients with mycological cure of target nail, defined as negative fungal culture and negative direct microscopy, at 12 months.
A Phase III, Double-Blind, Placebo Controlled, Parallel Group, International, Multicenter Study of 12 Weeks Treatment with Trafermin 0.01% Spray in Patients with Diabetic Foot Ulcer of Neuropathic Origin.Aug 2010
To demonstrate a superior wound closure rate of DFUs of neuropathic origin after a maximum of 12 weeks topical daily application of trafermin 0.01% spray compared with placebo, in addition to best local care. Wound closure is defined as 100% reepithelialization of the target DFU (i.e. the target wound only), without exudates.
A randomized, double-blind, vehicle-controlled, multicenter, parallel group study to assess the efficacy, safety, and tolerability of topical terbinafine hydrogen chloride (HCl) formulation for 24 or 48 weeks of treatment in patients with mild to moderate toenail onychomycosisOct 2006
To demonstrate the superiority of topical terbinafine HCl formulation vs. vehicle in terms of complete cure rate in patients with mild to moderate toenail onychomycosis at the end of study (i.e., 52 weeks after the initial application) after treating for 24 or 48 weeks.