Conectar
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.
Diabetic foot ulcers (DFUs) are a major cause of infection, hospitalisation, and amputation. Collagen-based dressings—especially collagen combined with oxidised regenerated cellulose (ORC)—are proposed to improve healing by modulating matrix metalloproteinases (MMPs), stabilising the extracellular matrix (ECM), and tempering inflammation; some formulations also include antimicrobial or bioactive adjuncts. We conducted a systematic review of randomised controlled trials (RCTs) following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidance. Adults with DFUs were eligible. Interventions included collagen-alone or collagen-combination dressings (e.g., collagen–oxidised regenerated cellulose [collagen–ORC]/silver, collagen–chitosan) versus standard of care (SOC) or alternative dressings. To ensure comparable outcomes, the quantitative synthesis was pre-specified and restricted to complete wound closure (yes/no, intention-to-treat [ITT]) from collagen-combination RCTs with aligned constructs; other outcomes were synthesised narratively. Meta-analyses were performed in Microsoft Excel using Mantel–Haenszel methods for risk ratios (RR) with a fixed-effect primary model and DerSimonian–Laird random-effects sensitivity analysis; heterogeneity was summarised with Cochran's Q, between-study variance (τ 2), and Higgins' I 2 statistic (I 2), and a 95% prediction interval was reported for random-effects. (Protocol not registered). Six studies (five randomized controlled trials and one single-blinded non-randomized comparative study; total n = 314) met inclusion. In a focused meta-analysis of the two collagen-combination RCTs, treatment was associated with a higher probability of complete wound closure versus control (RR 1.69, 95% confidence interval [CI] 1.05–2.72; I 2 = 0%). One assessor-blinded RCT of collagen alone reported higher 12-week closure versus a placebo dressing and was not pooled due to heterogeneity. Across studies, signals also favored collagen-based care for earlier area reduction and, in one trial, fewer infection-related withdrawals; mechanistic work showed reductions in MMP-9/TIMP-2. However, most trials were small and single-centre, comparators and adjuncts varied, follow-up was short (~8 days–24 weeks, clinical endpoints typically 4–20 weeks), outcome definitions were non-standardised, and key confounders (off-loading, infection management, vascular status, glycaemic control) were inconsistently addressed. Collagen-based dressings—particularly collagen-combination formulations—appear to improve complete closure when added to the standard of care (SOC) for diabetic foot ulcers (DFUs), but the evidence is limited by study size, heterogeneity, and risk of bias. Larger, prospectively registered, multicentre RCTs with standardised outcomes and longer follow-up are needed to define clinical and cost-effectiveness and to identify which patients benefit most. Collagen–ORC dressings show promise as an adjunctive treatment for DFUs by influencing the inflammatory microenvironment and supporting tissue repair. However, the certainty of the current evidence remains limited, highlighting the need for further high-quality randomised studies.
A novel advanced synthetic bioactive glass matrix was studied in patients with non-healing diabetic foot ulcers (DFUs). Bioactive glasses can be constructed to be biocompatible, with water-soluble materials in multiple geometries including fibre scaffolds that mimic the 3D architecture of a fibrin clot. In this trial, chronic, Wagner Grade 1 DFUs were randomised to receive borate-based bioactive glass Fibre Matrix (BBGFM) plus standard of care (SOC) therapy for 12 weeks or SOC alone. The primary study endpoint was the proportion of subjects that obtained complete wound closure at 12 weeks. Secondary endpoints included time to achieve complete wound closure at 12 weeks. In the modified intent-to-treat (mITT) analysis, 48% (32/67) treated with BBGFM plus SOC healed at 12 weeks compared to 24% (16/66) with SOC alone (p = 0.007). In the per protocol (PP) population, 73% (32/44) of subjects treated with BBGFM plus SOC healed versus 42% (16/38) in the SOC group (p = 0.007). Based on the success of this trial, BBGFM demonstrates faster healing of DFUs compared to SOC and should be considered in the treatment armamentarium for Wagner Grade 1 DFUs. Future trials should investigate the use of BBGFM for healing deeper chronic DFUs, other wound aetiologies, or complex surgical wounds.
FreshRSS