This study aimed to compare the 3-year recurrence rates of diabetic foot ulcers (DFU) and the rate of endovascular reintervention for chronic limb-threatening ischaemia (CLTI) to recurrence rates of advanced-stage cancers. We systematically collected original data reporting 3-year DFU recurrence from studies published through 2024 and calculated a pooled mean. These findings were compared to recurrence rates for advanced breast, prostate, colorectal, and lung cancers using contemporary sources from the National Cancer Institute and American Cancer Society. CLTI reintervention data were drawn from the BEST-CLI trial. The pooled 3-year DFU recurrence rate was 58%, while the CLTI reintervention rate was 50%—comparable to cancer recurrence rates: breast (25%–40%), prostate (30%–40%), colorectal (30%–50%), and lung (60%–80%). Despite these comparable risks, DFU and CLTI remain underrecognized in terms of their recurrent burden on individuals, families, and health systems. The data presented here underscore the need to reframe healed DFU and post-intervention CLTI not as an endpoint but as a remission—a state requiring structured surveillance and proactive management, much like in oncology. Developing interdisciplinary survivorship care plans for individuals with DFU and CLTI, modelled on those used in cancer care, may improve communication, enhance secondary prevention, and foster more ulcer-free, hospital-free, and activity-rich days.
The development of effective interventions for diabetes-related foot ulcers (DFU) healing is vital. This protocol outlines a pilot trial and qualitative study investigating ESWT in DFU healing. A pilot three arm placebo controlled double-blinded randomised controlled trial. Participants with a DFU will be randomised to high dose (500 shocks/cm2), low dose (100 shocks/cm2) or sham ESWT, in addition to standard care. The primary outcome will be deliverability of a definitive trial. Secondary outcomes are ulcer healing, quality-of-life and healthcare resource use at 6 months. The target sample size is 90 participants. The study is registered on clinicaltrials.gov, reference: NCT05380544 and has ethical approval (REC reference: 22/WA/0089). The qualitative interview study will recruit participants who complete, drop-out and decline to participate in the pilot trial, and healthcare professionals who deliver DFU care. Maximum variable sampling will be used to recruit participants. Data will be analysed with an inductive exploratory approach using reflexive thematic analysis. The pilot trial will ensure methods used will address the research question in the definitive trial. The qualitative study will explore how patients and clinicians interact with the trial to understand the pilot trial findings.
Microbial biofilms are a major hindrance in the wound healing process, prolonging the inflammatory response phase, thus making them a target in treatment. The aim of this study is to assess the antibacterial properties of commercially available wound dressings, of various material composition and antibacterial agents, towards multiple in vitro microbial and biofilm models. A variety of in vitro microbial and biofilm models were utilised to evaluate the ability of wound dressing materials to sequester microbes, prevent dissemination and manage bioburden. Sequestering and dissemination models were used to evaluate the ability of wound dressing materials to prevent the biofilm-forming bacterium, Pseudomonas aeruginosa, from migrating through dressing materials over a 24–72 h challenge period. Additionally, Centre for Disease Control (CDC) Bioreactor and Drip Flow models were used to evaluate antibacterial killing efficacy towards established P. aeruginosa and Staphylococcus aureus biofilms using more challenging, wound-like models. Controlled-release iodine foam and silver-impregnated carboxymethylcellulose (CMC) wound dressing materials demonstrated potent biofilm management properties in comparison to a methylene blue and gentian violet-containing foam dressing. Both the iodine-containing foam and silver-impregnated CMC materials effectively prevented viable P. aeruginosa dissemination for up to 72 h. In addition, the controlled-release iodine foam and silver-impregnated CMC materials reduced P. aeruginosa bioburden in the Drip Flow model. The controlled-release iodine foam demonstrated superiority in the CDC Bioreactor model, as both the silver- and iodine-containing materials reduced S. aureus to the limit of detection, but P. aeruginosa growth was only completely reduced by controlled-release iodine foam dressing materials. The data generated within the in vitro biofilm models supports the clinical data available in the public domain for the implementation of iodine foam dressings for effective biofilm management and control in wound care.