Diabetic foot infections (DFI) are the most common cause of nontraumatic foot amputations in those with diabetes, occurring in about 15% of patients. These infections are generally found at the bottom of the foot within the soft tissue. Several pathogens, such as S. aureus, Enterococcus, P. aeruginosa, and E. coli, typically cause DFI infections, with 50-80% of wounds being polymicrobial.
The total medical cost for treating diabetic foot diseases in the U.S. is $9-13 billion per year. Studies have shown that between 14-24% of patients with diabetes who develop a foot ulcer will require an amputation, and foot ulceration precedes 85% of diabetes-related amputations.
diabetic foot ulcer cases annually.
amputations are performed annually on patients with diabetes
About RECCE® 327 Topical
RECCE® 327 (R327) is a synthetic anti-infective developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria, including the full suite of ESKAPE pathogens, even in their superbug forms. R327’s novel mechanism of action (MOA) is designed to safely enter the body, identify and treat an infection, and exit – with the potential to overcome antimicrobial resistance.
R327, as a topical therapy, is being studied in a broad range of bacterial wounds, burns, and skin infections.
In a preclinical study in rats, R327 showed significant antibacterial activity against Methicillin-resistant Staphylococcus aureus (MRSA), difficult-to-treat bacteria that causes staph infections. The data demonstrated a reduced bacterial load and a higher percentage of wound closure with increasing doses of R327 compared to Soframycin.
In an ongoing Phase I/II study in patients with infected burn wounds, R327, as a topical spray, has demonstrated promising data thus far with the return of healthy skin growth, reduced swelling and infection, and indications of tissue penetration to the underlying infection.
Ongoing Clinical Trials
Building upon the early positive data from the Phase I/II burn wound trial, Recce has launched a Phase I/II proof-of-concept study, evaluating the safety and efficacy of topical R327 in patients with mild skin and soft tissue diabetic foot infections (DFIs). The study is being conducted at the South West Sydney Limb Preservation and Wound Research Unit and has been approved by Human Research Ethics Committee (HREC).
Outpatient Nurses Appointed and Patient Population Increased