Theodorakopoulos George, Armstrong David G
Wound and Foot Specialist, Athens, Greece.
Technological Educational Institute of Patras, Patras, Greece.
Int Wound J. 2025 Dec;22(12):e70795. doi: 10.1111/iwj.70795.
Biofilms are a key driver of chronicity and treatment failure in diabetic foot ulcers (DFUs), yet clinical evidence quantifying their impact and management remains fragmented. This systematic narrative review synthesised recent evidence (2015-2025) on the prevalence, diagnostics, and management of biofilm in DFUs. A Systematic Review of the Literature (SRL) was conducted following PRISMA 2020 guidelines across PubMed/MEDLINE, Scopus, Cochrane Library and ScienceDirect. Eligible studies included adults with DFUs reporting biofilm/bioburden metrics or interventions aimed at biofilm disruption. Risk of bias was assessed using RoB 2 for randomised trials and ROBINS-I for non-randomised studies. Data were narratively synthesised by evidence tier (Tier 1 = clinical; Tier 2 = preclinical/mechanistic). Of 600 records screened, 25 studies met inclusion criteria (Tier 1 n = 9; Tier 2 n = 5; reviews n = 11). Over half of bacterial isolates in DFUs were biofilm producers, with multidrug resistance exceeding 90% in several cohorts. Fungi were detected in 31% of ulcers by qPCR but only 9% by culture. Tier 1 clinical evidence supports standard care components-debridement, antiseptics, and negative-pressure wound therapy-for improved healing, though direct antibiofilm outcomes remain limited. Emerging strategies (enzymatic agents, peptides, cold plasma, smart dressings) show promise in vitro but lack clinical translation. Evidence for direct antibiofilm efficacy in DFUs remains scarce. Current data justify maintaining guideline-based care while prioritising trials that integrate validated biofilm endpoints, standardised microbiological methods, and antifungal components. Distinguishing established from experimental approaches is essential to advancing safe, evidence-based biofilm management in DFUs.
生物膜是糖尿病足溃疡（DFU）慢性化和治疗失败的关键驱动因素，但量化其影响和管理的临床证据仍然零散。本系统叙述性综述综合了近期（2015 - 2025年）关于DFU中生物膜的患病率、诊断和管理的证据。按照PRISMA 2020指南，在PubMed/MEDLINE、Scopus、Cochrane图书馆和ScienceDirect上进行了文献系统综述（SRL）。符合条件的研究包括报告生物膜/生物负荷指标或旨在破坏生物膜的干预措施的成年DFU患者。使用RoB 2评估随机试验的偏倚风险，使用ROBINS - I评估非随机研究的偏倚风险。数据按证据层级（第1层 = 临床；第2层 = 临床前/机制性）进行叙述性综合。在筛选的600条记录中，25项研究符合纳入标准（第1层n = 9；第2层n = 5；综述n = 11）。DFU中超过一半的细菌分离株是生物膜产生菌，在几个队列中多重耐药率超过90%。通过qPCR在31%的溃疡中检测到真菌，但通过培养仅检测到9%。第1层临床证据支持清创、防腐剂和负压伤口治疗等标准护理组件可促进愈合，尽管直接的抗生物膜效果仍然有限。新兴策略（酶制剂、肽、冷等离子体、智能敷料）在体外显示出前景，但缺乏临床转化。DFU中直接抗生物膜疗效的证据仍然稀缺。当前数据证明应维持基于指南的护理，同时优先开展整合经过验证的生物膜终点、标准化微生物学方法和抗真菌成分的试验。区分既定方法和实验方法对于推进DFU中安全、循证的生物膜管理至关重要。
