Medscape Diabetes & Endocrinology > ADA 2024
David G. Armstrong, DPM, MD, PhD
DISCLOSURES | June 24, 2024
At the recent American Diabetes Association (ADA) Scientific Sessions, researchers unveiled promising data on a novel antimicrobial peptide PL-5 spray. This innovative treatment shows significant promise for managing mild to moderate infected diabetic foot ulcers.
Of the 1.6 million people with diabetes in the United States and the tens of millions of similar people worldwide, 50% will require antimicrobials at some time during their lifecycle. (Armstrong DG et al; Cortes-Penfield NW et al). Diabetic foot infections are difficult to treat due to their resistance to conventional therapies, often leading to severe complications, including amputations.
To address this issue, the antimicrobial peptide PL-5 spray was developed with a novel mechanism of action to potentially improve treatment outcomes. The study aimed to assess the clinical efficacy and safety of the PL-5 spray combined with standard debridement procedures in treating mild to moderate diabetic foot ulcers.
This multicenter, randomized, double-blind, placebo-controlled clinical trial was conducted in four hospitals across China. Participants with mild to moderate diabetic foot ulcers were randomly assigned in a 2:1 ratio to either the PL-5 group or the placebo group, both receiving standard debridement. The primary endpoint was clinical efficacy at day one after the end of treatment (EOT1). Secondary endpoints included clinical efficacy at day seven (EOT7), microbiological efficacy, drug-resistant bacteria clearance rate, wound healing rate, and safety outcomes evaluated at both EOT1 and EOT7.
The study included 47 participants, with 32 in the PL-5 group and 15 in the placebo group. Both groups had statistically comparable demographic and clinical characteristics. The primary endpoint showed a higher clinical efficacy (cure/improvement ratio) in the PL-5 group compared with the control group (1.33 vs 0.55; P =.0764), suggesting a positive trend but not reaching statistical significance in this population.
Among the secondary endpoints, clinical efficacy at EOT7 was significantly higher in the PL-5 group than in the control group (1.6 vs 0.86). Microbial eradication rates were notably better in the PL-5 group at both EOT1 (57.89% vs 33.33%) and EOT7 (64.71% vs 40.00%). The clearance rates of drug-resistant bacteria were also higher in the PL-5 group at EOT1 (71.43% vs 50%).
Of importance, safety parameters showed no significant differences between the two groups (24.24% vs 33.33%), highlighting the favorable safety profile of PL-5 spray.
The study presented at the ADA Scientific Sessions provides a glint of promising evidence supporting the potential efficacy and safety of PL-5 spray in treating mild to moderate diabetic foot infections. Despite the limited sample size, the results suggest that PL-5 spray may enhance the recovery speed of diabetic foot wounds, particularly in clearing drug-resistant bacterial infections. These findings justify further investigation with larger sample sizes to confirm or refute the efficacy and potentially establish PL-5 spray as a standard treatment option in diabetic foot care.
The novel antimicrobial peptide PL-5 spray shows potential in addressing the challenging issue of diabetic foot infections. This recent ADA presentation sparked significant interest and discussions about the future of diabetic foot ulcer treatments, emphasizing the importance of innovative approaches in managing complex diabetic complications.
Leave a Reply