Mild Diabetic Foot Infections

Dipexium’s primary objective is to establish Locilex® as the standard of care for the treatment of mild infections of diabetic foot ulcers (Mild DFI).

Foot infection is the most frequent diabetic complication requiring hospitalization and the most common precipitating event leading to lower limb amputation. According to the Infectious Disease society of America (IDSA), diabetic foot infections may be classified by their clinical severity as mild, moderate, or severe. Approximately 1.35 million patients are diagnosed with DFI each year in the US, of which approximately 47% present at the mild stage. Here, patients can typically be treated on an outpatient basis and amputation risk is minimal (2 to 3%). When not managed effectively, the potential for Mild DFI to progress to a limb- or life-threatening infection increases dramatically. Published research suggests amputation rates increase in Moderate and Severe DFI to approximately 45% and 75%, respectively. Similarly, the hospitalization rate for Mild DFI patients is approximately 10%, increasing in Moderate and Severe DFI to approximately 55% and 85%, respectively. Thus, DFIs are a major cause of patient morbidity, a substantial burden to the healthcare system, and a source of high financial costs.

The goal of any antibiotic regimen is to treat patients with the least invasive therapy for the shortest amount of time, such that infection control can be achieved while minimizing the risk of antibiotic resistance and side effects. While various systemic antibiotics have been approved to treat more severe levels of DFI, according to the 2012 IDSA Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections, there is no standard of care in Mild DFI. In the absence of any approved treatment for Mild DFI, oral antibiotics, such as quinolones, cephalosporins, or penicillins, are considered to be acceptable for off-label use. All oral antibiotics are associated with systemic toxicity and antibiotic resistance.

According to published research, there has long been interest in treating Mild DFI, with topical antibacterial agents, however to date, no topical agent has been approved. In Mild DFI, assuming equivalent or greater efficacy, we believe that a topical treatment such as Locilex® could hold significant advantages over oral therapies by avoiding systemic adverse events, providing increased target site concentration, and avoiding patient exposure to systemic antibiotic resistance.

Locilex® Clinical Results in Mild DFI to Date

As published in a major medical journal, in a previously conducted U.S. based, randomized, double-blind, multi-center, Phase 3 clinical trial in patients with mild and moderate infections of diabetic foot ulcers, Locilex® demonstrated statistically significant non-inferiority to an oral antibiotic, ofloxacin. To our knowledge, this is the only Phase 3 trial to ever demonstrate non-inferiority of a topical antibiotic to a systemic antibiotic in diabetic foot infections.

To view a PDF of the prior Phase 3 data publication, please visit our Key Publications page.