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☐ ☆ ✇ International Wound Journal

Reliability and Validity of the Italian Translation of the Updated Version of the Pressure Ulcer Knowledge Assessment Tool (PUKAT 2.0)

ABSTRACT

The study aimed to translate the PUKAT 2.0 tool from English to Italian. This was an adaptation and validation study; the validity of the Italian version was determined through content validity, item validity and construct validity. The reliability of the instrument was assessed by conducting a test–retest analysis on a sample of 62 nurses. The I-CVI indices were above the threshold of 0.78 for 91% of the questions, and according to the S-CVI index, 96% of the evaluators agreed that the questionnaire was highly relevant. The overall values for item difficulty were good, with two items being too difficult and none being too easy. The item discriminant index was overall good and reasonable, low for four items. The overall ICC was poor to moderate with a value of 0.48 (95% CI 0.26–0.65). The instrument has proven to be a good starting point although not yet completely reliable, as it clearly requires more basic preparation on the part of the staff, further modifications regarding the reliability and clarity of the questions and more training of the nursing staff if it is to be used in the Italian context.

☐ ☆ ✇ International Wound Journal

Comparative Analyses of Cyanoacrylates for Barrier Protection and Incontinence‐Related Wash‐Off Resistance

ABSTRACT

A comprehensive skincare regimen involves cleansing, moisturising, and using skin barrier protectants. Cyanoacrylate-based protectants safeguard vulnerable skin from damage caused by moisture, friction, and shear. This research involved two ex vivo and two clinical studies comparing the wear duration and wash-off resistance of a 100% cyanoacrylate and a solvent-cyanoacrylate mixture. Effectiveness was assessed using an ex vivo porcine skin model simulating urinary incontinence, evaluated with Lucifer yellow dye penetration and Corneometry, and a clinical model using Corneometry. Two single-blind clinical studies measured skin surface electrical capacitance in healthy volunteers. Study 1 (n = 42) evaluated the wear duration over 8 days, while Study 2 (n = 52) examined wash-off resistance after nine washes with various cleansers. Ex vivo results showed that both products were effective under repeated moisture and abrasion conditions, with the 100% cyanoacrylate outperforming the solvent-cyanoacrylate mixture. In clinical studies, both products maintained barrier protection throughout Study 1 (p < 0.007) and none of the cleansers significantly degraded either product in Study 2. In conclusion, the 100% cyanoacrylate provided superior protection compared to the solvent-cyanoacrylate mixture. Both products demonstrated comparable wear duration and wash-off resistance in clinical studies, but the 100% cyanoacrylate was more effective in ex vivo testing under harsh conditions.

☐ ☆ ✇ International Wound Journal

Cultural Adaptation and Psychometric Assessment of the Catalan Version of the Wound‐QoL‐17

ABSTRACT

Complex chronic wounds are an increasing health concern, affecting individuals both physically and psychologically. To measure the quality of life of this population properly translated and validated questionnaires in their native language are needed. The aim of this work is to provide a validated instrument for measuring the quality of life in the Catalan speaking population with complex wounds. A cultural adaptation of the Wound-QoL-17 questionnaire into Catalan was carried out by independent official translators and the back translation was approved by the original author. Validity, reliability, responsiveness, and feasibility were assessed. Face and content validity were determined by a group of experts: the 17 items of the Wound-QoL-17 Catalan version were appropriate for their purpose. Reliability was demonstrated by an interclass correlation coefficient of 0.884 for the scores obtained by two different observers and of 0.928 for the same observer on two time points. Chronbach's alpha coefficient was 0.926. Responsiveness was proved by a Pearson's correlation coefficient of 0.661. Feasibility was shown by the time, 3.46 min, taken to complete the questionnaire.

☐ ☆ ✇ International Wound Journal

Clinical Study on Masquelet Membrane Induction Technique Combined With Free Skin Grafting for the Treatment of Chronic Refractory Wounds With Bone/Tendon Exposure in Aged Patients

Por: Jianyuan Gao · Shenkai Su · Feiya Zhou · Yingying Zhang · Guangheng Xiang · Zupo Yu — Enero 14th 2026 at 09:00

ABSTRACT

The treatment of chronic wounds in the Aged is often difficult. Masquelet technique is used for the treatment of infected large segmental bone defects as it provides an adequate blood supply for bone and soft tissue reconstruction. In this study, a two-stage wound management strategy was used, consisting of covering the initial wound with bone cement and skin grafting under induced membranes. From September 2020 to September 2022, 20 Aged patients with chronic refractory wounds of the lower extremities with exposed bone or tendons were recruited in the Department of Wound Repair Surgery of the Second Affiliated Hospital of Wenzhou Medical University. Each patient was reconstructed according to a two-stage process. In the first stage, while treating the patient's underlying disease, several debridements were first performed on the wound; subsequently, the Masquelet technique was applied to seal the wound with antibiotic bone cement. Four to 6 weeks later, the second stage was initiated—after confirming the sufficient formation of wound induced membranes, the bone cement was removed, and free skin grafts were finally used to cover the chronic refractory wounds on the extremities. The area of the defects ranged from 4.5 × 3.0 cm to 15.0 × 6.0 cm, and all soft tissue defects were associated with tendon or bone exposure. After the surgery, patients attended regular outpatient visits and were followed up by telephone and video to observe the healing of the wounds and whether there were any complications in the donor site. The Lower Extremity Function Scale (LEFS) score was used to evaluate the functional recovery of the lower extremities. We found that all implants survived without necrosis or infection. All 20 cases were followed up regularly after surgery for 3 to 12 months, with a mean of 7.6 months. In the first stage, Induced Membranes induction was performed 1–4 times, with an average of (1.3 ± 0.7) times, and in the second stage, free skin grafting was performed on the induction membrane, and all 20 cases of skin grafting survived without necrosis or infection; the appearance and texture of the skin in the grafted area were satisfactory, and the postoperative LEFS score was (69.83 ± 10.82). Finally, our strategy for the management of chronic refractory wounds in the Aged can achieve satisfactory clinical results, reduce surgical risk, be simple and reliable, and be an effective addition to the repair modality.

☐ ☆ ✇ International Wound Journal

Developing an Evidence‐Based and Patient‐Centred Care Concept to Address Deficits in German Primary Care of Venous Leg Ulcers: Results of an Expert Survey Within the ULCUS CRURIS CARE Project

ABSTRACT

Venous leg ulcers (VLU) account for the majority of chronic wounds, with an estimated rise in prevalence due to demographic change. Care often does not comply with evidence, and patients remain passive and uninformed. To support general practice VLU care, the ‘UlcusCrurisCare’ (UCC) project developed a multimodal intervention comprising provider training, software-supported case management and standardised patient education. Experts from the medical community (physicians, nurses, association of medical assistants), health insurance and patient representatives provided their assessment of barriers in VLU care, requirements for intervention components and their expected effects. Semi-structured interviews and questionnaires were used at two measuring points. Qualitative data analysis was based on the Theoretical Domains Framework. Quantitative data were analysed descriptively. Ten experts named a lack of knowledge and application regarding compression therapy, reluctance to assume role as primary care provider, and inadequate remuneration as barriers for evidence-based VLU care. To effectively address these barriers, interventions are required to foster the use of compression therapy and patient education. A multimodal approach such as pursued in UCC is expected to effectively address deficits in VLU care at general practitioner level by promoting provider knowledge about evidence-based treatment and supporting patient adherence.

☐ ☆ ✇ International Wound Journal

A Novel Murine Model for Studying Impaired Wound Healing in Diabetes

ABSTRACT

A lack of murine models that mimic impaired wound healing in people with type 2 diabetes has hindered research. The commonly used leptin-receptor knockout model (db/db) fails to accurately reflect the pathophysiology of human disease. This study aimed: (i) to investigate whether our novel murine model of diabetes, whilst less hyperglycaemic and obese than db/dbs, effectively demonstrated impaired wound healing, and (ii) to identify the most robust methods for quantifying wound closure. C57BL/6J mice were high-fat diet fed for a total of 11 weeks and injected with three doses of streptozotocin (65 mg/kg body weight) at week 5 with chow-fed mice as controls. All mice received four excisional wounds and were euthanised at day-4 or day-10 post-wounding (n = 8/group/timepoint). Wound healing was evaluated by digital planimetry, histology, Micro-CT, and tensiometry. Histological analysis was the most sensitive method for identifying impaired wound healing. Our high-fat diet/low-dose streptozotocin model had significantly higher non-fasting blood glucose (25.7 ± 5.4 mmol/L vs. 8.7 ± 0.8 mmol/L) and lower wound quality scores (day-4 post-wounding: 2.6 ± 1.9 vs. 4.4 ± 0.8) than healthy controls (both p < 0.05). At day-10 post-wounding, a linear trend in wound healing was observed between healthy controls, our novel model and the db/db model, indicating that our diabetic murine model may be clinically relevant for studying diabetes-related wound healing.

☐ ☆ ✇ International Wound Journal

Nurses' Perceptions of Fundamental Care in Preventing Venous Ulcer Recurrence: A Qualitative Focus Group Study

ABSTRACT

Venous ulcers are the most prevalent among those affecting the lower limbs, with high economic and quality of life impact. Due to the chronicity of venous disease, healing and recurrence cycles are common. Patient adherence to self-care activities to prevent recurrence is very low, so it is crucial to reflect on nurses' experiences with this phenomenon. A qualitative and descriptive study was developed to analyse nurses' perceptions about preventing venous ulcer recurrence. According to the inclusion criteria, focus groups with nurses were implemented. Three focus groups were conducted through the Colibri platform, ensuring all ethical assumptions. Content analysis was performed according to thematic criteria, using the WebQda software. Three main themes emerged: integration of care, context of care, and relationship. The participants emphasised the importance of holistic assessment and the establishment of common goals to promote adherence to fundamental recurrence prevention care. Understanding and respecting individual values, empathy and active listening, considering the established relationship, anticipating the person's needs, and trust are essential to overcoming barriers to implementing recurrence prevention care and to its continuity. Taking these aspects into consideration implies that the professional is part of the process of preventing the recurrence of venous ulcers.

☐ ☆ ✇ International Wound Journal

The Effectiveness, Safety and Cost‐Effectiveness of Platelet‐Rich Plasma and Platelet‐Rich Fibrin in the Treatment of Venous Leg Ulcers: A Systematic Review and Meta‐Analysis

ABSTRACT

Venous leg ulcers occur due to chronic venous insufficiency in the lower extremities and are often difficult to heal. Platelet-rich plasma and platelet-rich fibrin are products that contain high concentrations of platelets. This systematic review evaluated the effectiveness, safety and cost-effectiveness of these products for the treatment of venous leg ulcers. Guided by the 2020 Joanna Briggs Institute systematic review of effectiveness guideline, this review included original studies that investigated platelet-rich plasma and platelet-rich fibrin in the treatment of venous leg ulcers from databases including the Cochrane Library, Embase, Medline, CINAHL, PubMed, World Health Organisation International Clinical Trials Registry, Clinical Trials.gov and Australian New Zealand Clinical Trials Registry. Methodological quality was assessed using relevant appraisal checklists. Information related to general characteristics of included articles and relevant outcomes of interest were extracted and synthesised narratively. Of thirty-six eligible studies, 24 studies used platelet-rich plasma, eleven investigated fibrin-rich plasma and one study used both platelet-rich plasma and fibrin-rich. Most studies reported these products were effective in promoting wound healing, reducing other symptoms, and were safe to use. The use of platelet-rich plasma and platelet-rich fibrin resulted in significantly higher healed venous leg ulcers compared to control using conventional treatment (RR: 2.93, 95% CI, 1.90–4.53, p = 0.01). These products were safe to used topically and promoted to wound healing, reduced pain, either along or combined with other treatments. Platelet-rich plasma and fibrin-rich plasma improves wound healing and appears to be safe to use in the treatment of venous leg ulcers.

☐ ☆ ✇ International Wound Journal

Diabetic Ray Amputation Wounds Managed With Local Flap Surgery and Negative Pressure Wound Therapy: A Case Series

Por: Jack Kian Ch'ng · Charyl Jia Qi Yap · Michelle Jiaqi Mo · Khong Yik Chew · Wenxian Png · Jiajun Feng — Enero 11th 2026 at 09:00

ABSTRACT

A new surgical technique for ray amputation of the diabetic foot is described. The procedure provides soft tissue reconstruction using a local flap in combination with negative pressure wound therapy to close these wounds safely and effectively. This article reports on 12 patients treated with this technique in a Tertiary Hospital/General Hospital in Singapore and compares their outcomes to those of 12 comparative cases from neighbouring institutions under the same health group who received conventional dressings. The new technique led to a higher number of healed wounds (12 vs. 4) and a shorter median time to healing (46.5 vs. 196.5 days). No major amputation or further minor amputation of the target limb occurred in the group treated with the new technique, whereas one major amputation and two further minor amputations took place in the comparison group. Our results suggest that the new technique is promising in this diabetic population with concurrent comorbidities.

☐ ☆ ✇ International Wound Journal

Hyperbaric Oxygenation of an Ozone‐Containing Steam–Water Mixture as Treatment of Infected Combat Wounds of the Limbs With Antibiotic‐Resistant Microflora

ABSTRACT

Patients with combat wounds and injuries, presented as extensive infected and purulent defects with antibiotic-resistant microflora, were treated in a surgical inpatient setting. Closure of extensive soft tissue defects of the limbs is possible using methods of plastic and reconstructive surgery and requires preoperative infection control. The lack of effect from preoperative treatment for purulent limb defects with antibiotic-resistant microflora leads to limb amputation. This clinical study proposes a method of treatment by hyperbaric oxygenation with an ozone-containing steam–water mixture as an anti-bacterial agent. Eighteen male patients, aged between 20 and 60 years, were categorised into three groups based on the time elapsed since the injury. All patients were treated using the proposed method. The high effectiveness of the proposed method was demonstrated in all groups and resulted in saving limbs from amputation, establishing suitable conditions for closing the soft tissue defects of the limbs and achieving significant progress in the recovery.

☐ ☆ ✇ International Wound Journal

What Primary Care Physicians Expect From Continuing Medical Education in Wound Management—A Survey Study

Por: Veerakaisa Koivunen · Tuukka Veija · Heli Lagus · Kirsi Isoherranen · Maarit Venermo · Virve Koljonen — Enero 9th 2026 at 16:40

ABSTRACT

We aimed to investigate the learning needs of general practitioners and their preferences as regards the most appropriate teaching session for continuing medical education in wound management. A survey targeting general practitioners at the public health centres in the City of Helsinki. Twenty-seven general practitioners participated in the study. The majority (74.1%) had received education in medical school, 40.7% from wound care nurses, and 40.7% from colleagues. Participants felt the most competent in wound diagnosis (59.3%) and etiological tests (55.6%) and requested training in these topics (74.1% and 74.1%). A peer-led lecture (88.9%) was the most preferred technique, followed by lectures by wound care nurses (55.6%), an educational video (44.4%), a specialist-led lecture (37.0%), an interactive wound product session (29.6%), and digital self-study (29.6%). Wound diagnostics and etiological tests are recognised as crucial topics for continuing medical education. Peer-led lectures were preferred over other techniques; however, we observed varying preferences regarding the most optimal technique. Based on our results, we propose a half-day training including lectures, interactive and hands-on activities, and reflection, led by a peer and a wound care nurse with supporting video materials. Future studies could assess its impact on learning outcomes and wound care quality.

☐ ☆ ✇ International Wound Journal

Automated Periosteal Distraction for Limb Salvage in Diabetic Foot Ulcers With Chronic Limb‐Threatening Ischemia (Brief Communication)

Por: Lucian M. Feraru · Tze Woei Tan · David G. Armstrong — Enero 8th 2026 at 07:55

ABSTRACT

Chronic limb-threatening ischemia (CLTI) compounded by diabetic foot ulceration remains a leading precursor to major lower-extremity amputation. Transverse tibial transport (TTT) can improve perfusion but requires corticotomy and bulky external fixation. We report what is, to our knowledge, the first application of fully automated tibial periosteal distraction (PD) for limb preservation. A 65-year-old man with recurrent forefoot gangrene underwent tibial PD using a miniaturised, programmable motor to gradually elevate the periosteum. Through a 1 cm incision, a low-profile subperiosteal plate was implanted and linked to the motor, which advanced 0.031 mm hourly (0.75 mm/day) up to 10 mm. Distraction was completed uneventfully over 13 days, and the device was removed at the bedside on Day 21. Skin temperature increased by 2°C, and digital systolic (toe) pressure rose from 22 to 50 mmHg. The wound progressed to healing without complication. Automated PD may offer a minimally invasive, biologically driven alternative for high-risk CLTI patients, eliminating the need for patient-adjusted screws and standardising adherence. Prospective studies are required to validate its safety, durability, optimal distraction parameters and cost-effectiveness.

☐ ☆ ✇ International Wound Journal

Predictors of Patient Participation in Pressure Injury Prevention: An Observational Substudy

Por: Wendy Chaboyer · Rachel Walker · Emma Harbeck · Sharon Latimer · Marie Cooke · Brigid M. Gillespie — Enero 5th 2026 at 08:23

ABSTRACT

Patient participation improves patient outcomes, but factors that predict participation in pressure injury prevention (PIP) are relatively unknown. This study aimed to identify patient-related factors predictive of patient participation in pressure injury prevention (PPPIP) in hospitalised medical and surgical patients and to assess the psychometric properties of the PPPIP scale. This observational substudy recruited consenting adults at risk of pressure who participated in a parent trial. The seven-item PPPIP scale was administered within 48 h of recruitment, with higher scores reflecting more participation. Multiple regression was used to identify patient-related factors predictive of patient participation. The scale's psychometric properties were assessed using confirmatory factor analysis and Cronbach's alpha. In total, usable data were obtained from 856 patients. Mean PPPIP scale scores were relatively high, with 571 (66.7%) scores reflecting agreement or strong agreement. The Cronbach's alpha was 0.81, and most confirmatory factor analysis criteria for construct validity were met. Only the use of mobility aids was statistically significant in the model, but it predicted a small amount of variability in PPPIP score (adjusted R 2 = 0.017; p < 0.001). Targeting patients with limited mobility may be a useful strategy when trying to engage patients in PIP if resources are limited.

☐ ☆ ✇ International Wound Journal

Issue Information

— Enero 5th 2026 at 05:44
International Wound Journal, Volume 23, Issue 1, January 2026.
☐ ☆ ✇ International Wound Journal

Single‐Center Epidemiological Analysis of Malignant Transformation With Skin Ulcers in Outpatients

ABSTRACT

Investigate the epidemiological characteristics of outpatients initially diagnosed with skin ulcers who were ultimately confirmed to have cutaneous malignant tumours, and provide a diagnostic and therapeutic basis for the occurrence of secondary diseases in chronic wounds. We conducted a retrospective study analysing clinical data from patients initially diagnosed with skin ulcers at our hospital between July 2021 and February 2025, and analysed the epidemiological characteristics of malignant transformation in these ulcer cases. Among 128 patients initially diagnosed with skin ulcers, 16 cases (12.5%) were confirmed with cutaneous malignancies. The malignant group had a significantly higher mean age (69.44 ± 11.30 years) compared to the non-malignant group (58.39 ± 17.88 years; t = 5.752, p = 0.01). The distribution of lesion sites differed significantly between the malignant and non-malignant groups (χ2 = 30.498, p < 0.01). In the malignant group, the head and neck (41.2%) and trunk & extremities (41.2%) were the predominant sites. The most common malignancy was squamous cell carcinoma (SCC). The trunk & extremities was the most frequent site (62.5%). The second was basal cell carcinoma, which mainly occurs in the head and neck (80.0%). The mean duration of ulceration was 4.5 years. The primary treatment modality was surgical excision (11 cases, 68.8%). Approximately one-seventh of skin ulcer cases were confirmed as cutaneous malignancies. This finding underscores the significance of skin ulcers as potential malignant lesions, highlighting the need for clinicians to maintain a high index of suspicion and promptly perform histopathological examinations to improve early detection rates of skin cancers.

☐ ☆ ✇ International Wound Journal

Risk Factors for Pressure Injuries and Injury Types Among Inpatients in Multi‐Centre Military Hospitals: A Factor Analysis Study

Por: Jianying Yu · Juhua Long · Yuan Cen · Xiaolian Deng · Ying Qiu — Diciembre 16th 2025 at 04:50

ABSTRACT

Pressure injuries remain a significant concern in military hospital settings, leading to increased morbidity and healthcare costs. Understanding the interplay of multiple risk factors is critical for effective prevention. To identify key risk factors and their combined effects on pressure injury development among inpatients in multi-centre military hospitals using factor analysis. A cross-sectional study was conducted involving 4876 inpatients across multiple military hospitals. Data were collected on 15 potential risk factors, including incontinence, care dependency, mobility limitations, comorbidities, medication use, nutritional status, and demographics. Factor analysis with principal component analysis and varimax rotation was applied, and maximum canonical correlation coefficients were calculated to evaluate the predictive contribution of single and combined factors. Single-factor analysis identified incontinence as the strongest predictor (MaxCanonicalCorr = 0.50126), followed by care dependency (0.31982) and bedridden status (0.30061). Two-factor analysis revealed incontinence combined with care dependency as the highest-performing model (MaxCanonicalCorr = 0.50867). Three-factor models incorporating incontinence, health conditions, and care dependency achieved the greatest predictive capacity (MaxCanonicalCorr = 0.5157), demonstrating that multi-factor interactions enhance risk prediction beyond single-factor effects. Incontinence is the primary modifiable risk factor for pressure injury in military hospital inpatients. Integrating continence management with assessments of functional status and comorbidities can improve early identification of high-risk patients and guide targeted preventive strategies.

☐ ☆ ✇ International Wound Journal

Sick Becomes Seriously Ill—Scald Injuries due to Domestic Medical Self‐Treatment: A Six‐Year Single Center Retrospective Study

Por: Harun Seyhan · Jan Akkan · Jennifer L. Schiefer · Paul C. Fuchs · Wolfram Heitzmann · Mahsa Bagheri · Marc Daniels — Diciembre 15th 2025 at 05:31

ABSTRACT

Self-treatment of benign symptoms using hot water bottles, steam inhalation or hot tea is common in households and poses risks of severe scald injuries. This study aims to investigate associated hazards and identify high-risk patient groups to facilitate targeted prevention. A retrospective, single-center descriptive study was conducted on adult burn patients with scald injuries from hot water bottles, steam inhalation or hot tea. Demographic information, injury mechanism and outcomes were analysed. A total of 43 patients (mean age: 37.5 years; female:male ratio 23:20) were included. Injuries were caused by hot water/tea (37.2%), steam (34.9%) and hot water bottles (27.9%). The average burned total body surface area (TBSA) was 4%, with 79.1% of injuries being superficial partial-thickness burns. Surgical intervention was required in 13.9% of cases. Hot water bottle injuries predominantly affected young females (75%, mean age 32.6 years), with a high incidence of genital burns (58.3%). Hot tea-related injuries were more frequent in older males (62.5%, mean age 41.6 years), involving greater TBSA (6.5%) and a higher necessity for skin grafting (18.8%). Common self-treatment strategies can cause serious scalds, particularly in specific demographic groups, thereby burdening healthcare systems. Awareness of these risks is pivotal for effective education and prevention.

☐ ☆ ✇ International Wound Journal

Postbiotics as Emerging Therapeutics for Skin Wound Healing and Dermatological Care: Clinical Trends and Mechanistic Insights

Por: Seyedeh‐Sara Hashemi · Alireza Rafati · Shahin Roohinejad · Fatemeh Yaghoobi · Alireza Salehi — Diciembre 12th 2025 at 05:00

ABSTRACT

Postbiotics, non-viable microbial components or metabolites derived from probiotics, represent a promising new class of therapeutic agents in dermatological and wound-healing science. This review highlights the bioactive potential of postbiotics in modulating inflammation, enhancing tissue regeneration, and restoring microbiota balance in skin wounds. Through analysis of recent experimental and clinical studies, postbiotics were found to accelerate wound closure, stimulate collagen synthesis, and improve barrier integrity while providing antimicrobial and immunomodulatory benefits. Their incorporation into topical formulations and wound dressings has shown to regulate moisture, prevent infection, and support optimal healing conditions. In contrast to live probiotics, postbiotics are stable, safe, and free from viability-related limitations, making them ideal for cosmetic and medical use. Overall, postbiotics represent an innovative, next-generation strategy for skin regeneration and wound management.

☐ ☆ ✇ International Wound Journal

Biofilm in Diabetic Foot Ulcers: A Systematic Narrative Review

Por: George Theodorakopoulos · David G. Armstrong — Diciembre 4th 2025 at 04:50

ABSTRACT

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.

☐ ☆ ✇ International Wound Journal

Extracorporeal Shockwave Therapy for Diabetes Related Foot Ulcers: A Pilot Three‐Arm Double‐Blinded Randomised Controlled Trial

Por: L. Hitchman · R. Lathan · B. Ravindhran · M. Sidapra · J. Long · A. Cowling · A. Keding · J. Watson · C. Iglesias · G. Smith · M. Twiddy · D. Russell · I. C. Chetter — Diciembre 1st 2025 at 01:09

ABSTRACT

There is an urgent need for effective interventions to aid diabetes-related foot ulcer (DFU) healing. This study aimed to test the deliverability of a proposed trial of extracorporeal shockwave therapy (ESWT) for DFU healing. A pilot double-blinded randomised controlled trial. Patients with a DFU present for ≥ 4 weeks were randomised to high dose (500 shocks/cm2), low dose (100 shocks/cm2) or sham (0 shocks/cm2) ESWT, plus standard care. Follow-up was for 24 weeks. Primary outcome was deliverability of the trial. Secondary outcomes were healing, quality of life and healthcare resource use. One-hundred and forty-one (15.6%) screened patients were eligible and 74 (52.5%) patients were recruited. Follow-up attendance was 97.3% (72/74), 93.2% (69/74) and 87.8% (65/74) at 6, 12 and 24 weeks. The median DFU healing time was high dose: 54.0 (IQR 119.0), low dose: 78.5 (IQR 61.0) and sham: 83.0 (IQR 85.0) days. The mean EQ-5D-5L utility value at 24 weeks was high dose: 0.621 (95% CI 0.438–0.804), low dose: 0.779 (95% CI 0.683–0.876) and sham: 0.806 (95% CI 0.717–0.895). Healthcare resource use was lowest in the low-dose ESWT arm. The pilot trial has demonstrated that patients with a DFU are willing to engage in the proposed trial and suggest the optimal way to deliver the definitive trial.

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