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
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.
迫切需要有效的干预措施来帮助糖尿病相关足溃疡(DFU)愈合。本研究旨在测试体外冲击波治疗(ESWT)治疗DFU的可行性。一项先导双盲随机对照试验。DFU存在≥4周的患者随机分为高剂量(500次电击/cm2)、低剂量(100次电击/cm2)或假(0次电击/cm2) ESWT加标准治疗组。随访24周。主要结局是试验的可交付性。次要结局是康复、生活质量和医疗资源的使用。141名(15.6%)筛选的患者符合条件,74名(52.5%)患者被招募。6周、12周和24周的随访率分别为97.3%(72/74)、93.2%(69/74)和87.8%(65/74)。中位DFU愈合时间高剂量:54.0 (IQR 119.0),低剂量:78.5 (IQR 61.0),假手术:83.0 (IQR 85.0) d。24周时EQ-5D-5L的平均效用值为高剂量:0.621 (95% CI 0.438-0.804),低剂量:0.779 (95% CI 0.683-0.876),假手术:0.806 (95% CI 0.717-0.895)。低剂量ESWT组的医疗资源利用率最低。试点试验表明,患有DFU的患者愿意参与拟议的试验,并建议进行最终试验的最佳方式。
{"title":"Extracorporeal Shockwave Therapy for Diabetes Related Foot Ulcers: A Pilot Three-Arm Double-Blinded Randomised Controlled Trial","authors":"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","doi":"10.1111/iwj.70740","DOIUrl":"10.1111/iwj.70740","url":null,"abstract":"<p>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/cm<sup>2</sup>), low dose (100 shocks/cm<sup>2</sup>) or sham (0 shocks/cm<sup>2</sup>) 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.</p>","PeriodicalId":14451,"journal":{"name":"International Wound Journal","volume":"22 12","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12665375/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145648104","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Muneera Ben-Nakhi, Heitham Albeshri, Fahad Aljindan, Maram Alkhatieb, Ali Al-Malaq, Fatema Al Subhi, Mohamed Baguneid, Mario Cherubino, Samiah Faraj Mushara, Yasser Khattab, Saadia Laher, Marcelo A. F. Ribeiro Jr, Suléman Vadia, Sadhana Trivedi, Mark J. Portou
The number of patients requiring wound care is increasing, placing a burden on healthcare institutions and clinicians. While negative pressure wound therapy (NPWT) use has become increasingly common, Middle East-specific wound care guidelines are limited. An in-person meeting was held in Dubai with 15 wound care experts to develop guidelines for NPWT and NPWT with instillation and dwell (NPWTi-d) use for the Middle East. A literature search was performed using PubMed, Science Direct and Cochrane Reviews. Prior to the meeting, panel members reviewed literature and existing guidelines on NPWT and/or NPWTi-d use. A wound management treatment algorithm was created. Patient and wound assessment at presentation and throughout the treatment plan was recommended. Primary closure was recommended for simple wounds, and NPWT use was suggested for complex wounds requiring wound bed preparation. NPWTi-d use was advised when wound cleansing is required, if the patient is unsuitable for surgical debridement, or if surgical debridement is delayed. When NPWTi-d is unavailable, panel members recommended NPWT. Panel members recommended NPWT for wound bed preparation and NPWTi-d when wound cleansing is needed. These recommendations provide general guidance for NPWT and NPWTi-d use and should be updated as more clinical evidence becomes available.
{"title":"Negative Pressure Wound Therapy Use: Recommendations and Insights From a Middle Eastern Panel of Experts","authors":"Muneera Ben-Nakhi, Heitham Albeshri, Fahad Aljindan, Maram Alkhatieb, Ali Al-Malaq, Fatema Al Subhi, Mohamed Baguneid, Mario Cherubino, Samiah Faraj Mushara, Yasser Khattab, Saadia Laher, Marcelo A. F. Ribeiro Jr, Suléman Vadia, Sadhana Trivedi, Mark J. Portou","doi":"10.1111/iwj.70791","DOIUrl":"https://doi.org/10.1111/iwj.70791","url":null,"abstract":"<p>The number of patients requiring wound care is increasing, placing a burden on healthcare institutions and clinicians. While negative pressure wound therapy (NPWT) use has become increasingly common, Middle East-specific wound care guidelines are limited. An in-person meeting was held in Dubai with 15 wound care experts to develop guidelines for NPWT and NPWT with instillation and dwell (NPWTi-d) use for the Middle East. A literature search was performed using PubMed, Science Direct and Cochrane Reviews. Prior to the meeting, panel members reviewed literature and existing guidelines on NPWT and/or NPWTi-d use. A wound management treatment algorithm was created. Patient and wound assessment at presentation and throughout the treatment plan was recommended. Primary closure was recommended for simple wounds, and NPWT use was suggested for complex wounds requiring wound bed preparation. NPWTi-d use was advised when wound cleansing is required, if the patient is unsuitable for surgical debridement, or if surgical debridement is delayed. When NPWTi-d is unavailable, panel members recommended NPWT. Panel members recommended NPWT for wound bed preparation and NPWTi-d when wound cleansing is needed. These recommendations provide general guidance for NPWT and NPWTi-d use and should be updated as more clinical evidence becomes available.</p>","PeriodicalId":14451,"journal":{"name":"International Wound Journal","volume":"22 12","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/iwj.70791","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145601160","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Chronic diabetic foot ulcers (DFUs) complicated by osteomyelitis remain a major clinical challenge, often requiring aggressive treatments or surgical intervention. Novel non-invasive approaches such as laser and plasma therapy have shown promise in enhancing wound healing and reducing infection. As part of a broader study involving 20 patients with chronic DFUs (14 females and 6 males), a dual-modality treatment combining low-level laser therapy and PRP therapy was applied. Among the participants, two representative cases are presented in detail to highlight the clinical outcomes and treatment potential of this method. The first case involves a 65-year-old male with a chronic heel ulcer unresponsive to conventional therapies. The second case is a 58-year-old female with a necrotic toe and persistent ulceration. Treatment consisted of multiple sessions of laser and plasma therapy, integrated with standard wound care protocols. Progress was monitored through wound size, tissue regeneration, infection control, and overall healing response. Both patients demonstrated substantial clinical improvement, including resolution of necrotic tissue, reduction in wound size, and formation of healthy granulation tissue. No adverse effects were observed, and neither patient required surgical amputation. Further controlled studies are recommended to validate and generalise these findings.
{"title":"An Innovative Dual-Modality Approach Using Laser and Plasma Therapy in the Management of Chronic Diabetic Foot Ulcer With Osteomyelitis: A Case Series","authors":"Fatemeh Harsij Sani, Hadi Harsij Sani","doi":"10.1111/iwj.70796","DOIUrl":"https://doi.org/10.1111/iwj.70796","url":null,"abstract":"<p>Chronic diabetic foot ulcers (DFUs) complicated by osteomyelitis remain a major clinical challenge, often requiring aggressive treatments or surgical intervention. Novel non-invasive approaches such as laser and plasma therapy have shown promise in enhancing wound healing and reducing infection. As part of a broader study involving 20 patients with chronic DFUs (14 females and 6 males), a dual-modality treatment combining low-level laser therapy and PRP therapy was applied. Among the participants, two representative cases are presented in detail to highlight the clinical outcomes and treatment potential of this method. The first case involves a 65-year-old male with a chronic heel ulcer unresponsive to conventional therapies. The second case is a 58-year-old female with a necrotic toe and persistent ulceration. Treatment consisted of multiple sessions of laser and plasma therapy, integrated with standard wound care protocols. Progress was monitored through wound size, tissue regeneration, infection control, and overall healing response. Both patients demonstrated substantial clinical improvement, including resolution of necrotic tissue, reduction in wound size, and formation of healthy granulation tissue. No adverse effects were observed, and neither patient required surgical amputation. Further controlled studies are recommended to validate and generalise these findings.</p>","PeriodicalId":14451,"journal":{"name":"International Wound Journal","volume":"22 12","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/iwj.70796","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145601194","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Esra Süzen, Ömer Özkan, Özlenen Özkan, Ömer Halil Çolak, Ebru Apaydın Doğan, Buket Şimşek, Ayhan Şavklıyıldız, Kadriye Tombak, Hamza Feza Carlak, Ümit Deniz Uluşar, Övünç Polat, Şükrü Özen
This study investigates cortical reorganisation and hemodynamic responses in individuals with lower extremity amputation and replantation using functional near-infrared spectroscopy (fNIRS). A total of 15 healthy controls, four left lower limb amputees and one replantation patient were included. Oxyhemoglobin (oxy-Hb) activations were measured during 10 unilateral lower limb motor tasks (toe, ankle, knee and hip movements). Non-parametric analyses revealed significant differences in cortical activation between amputees and controls, particularly during knee flexion and extension. Three-dimensional contrast maps demonstrated that oxy-Hb activity in amputees extended from the M1-leg area into somatosensory regions, reflecting neuroplastic remapping. In contrast, the replantation patient exhibited activation patterns closer to the control group, especially in knee and hip tasks. These findings indicate that fNIRS can sensitively capture hemispheric dynamics during unilateral lower limb movements and highlight neuroplastic adaptations following amputation and replantation. Such insights may guide future neuroprosthetic design and rehabilitation strategies.
{"title":"Determination of Hemodynamic Response Using fNIRS in Lower Extremity Amputee and Replant Patients","authors":"Esra Süzen, Ömer Özkan, Özlenen Özkan, Ömer Halil Çolak, Ebru Apaydın Doğan, Buket Şimşek, Ayhan Şavklıyıldız, Kadriye Tombak, Hamza Feza Carlak, Ümit Deniz Uluşar, Övünç Polat, Şükrü Özen","doi":"10.1111/iwj.70792","DOIUrl":"10.1111/iwj.70792","url":null,"abstract":"<p>This study investigates cortical reorganisation and hemodynamic responses in individuals with lower extremity amputation and replantation using functional near-infrared spectroscopy (fNIRS). A total of 15 healthy controls, four left lower limb amputees and one replantation patient were included. Oxyhemoglobin (oxy-Hb) activations were measured during 10 unilateral lower limb motor tasks (toe, ankle, knee and hip movements). Non-parametric analyses revealed significant differences in cortical activation between amputees and controls, particularly during knee flexion and extension. Three-dimensional contrast maps demonstrated that oxy-Hb activity in amputees extended from the M1-leg area into somatosensory regions, reflecting neuroplastic remapping. In contrast, the replantation patient exhibited activation patterns closer to the control group, especially in knee and hip tasks. These findings indicate that fNIRS can sensitively capture hemispheric dynamics during unilateral lower limb movements and highlight neuroplastic adaptations following amputation and replantation. Such insights may guide future neuroprosthetic design and rehabilitation strategies.</p>","PeriodicalId":14451,"journal":{"name":"International Wound Journal","volume":"22 11","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-11-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12640720/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145587385","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Barbara De Angelis, Fabrizio Orlandi, Margarida Fernandes Lopes Morais D’Autilio, Stefano Mogavero, Ruggiero Marrano, Lorenza Marconi, Leonardo Palombi, Giovanna Scioli Maria, Augusto Orlandi, Paolo De Ninis, Lorenzo Secondi, Valerio Cervelli, Pietro Gentile
The article describes the outcomes of a single-centre investigation on the use of OZOILE to improve the healing process in patients with chronic diabetic ulcers. This is a non-randomised interventional study which aims to assess the differences between two groups (total 200 patients) by evaluating healing time at 15, 30, 45, 60, 75 and 90 days. Pain assessment with VAS scale at 15, 30 and 45 days, biofilm test and tissue regeneration by histological evaluation were also taken into consideration. The outcomes show faster healing, reduced pain, control of local infection, aesthetically pleasing and qualitatively better healing. Our treatment strategy involves applying OZOILE detergent without rinsing, Ozoile spray oil and Ozoile cream followed by a non-adherent dressing (paraffin gauze). This integrated protocol shows a safe and effective treatment for diabetic chronic wound healing in a cost-effective manner. The group treated with the Rigenoma/Ozoile protocol demonstrated significantly superior outcomes compared to the control group, including accelerated healing, reduced pain levels, effective management of unpleasant odour, and high levels of compliance from both patients and surgeons. Overall, Ozoile markedly reduced healing time compared with standard care, with results robust across multiple analytical approaches.
{"title":"Ozoile-Stable Ozonides, Derived From Organic Extravirgin Olive Oil, Enhance Wound Healing Process in Patients With Diabetic Chronic Ulcers","authors":"Barbara De Angelis, Fabrizio Orlandi, Margarida Fernandes Lopes Morais D’Autilio, Stefano Mogavero, Ruggiero Marrano, Lorenza Marconi, Leonardo Palombi, Giovanna Scioli Maria, Augusto Orlandi, Paolo De Ninis, Lorenzo Secondi, Valerio Cervelli, Pietro Gentile","doi":"10.1111/iwj.70786","DOIUrl":"10.1111/iwj.70786","url":null,"abstract":"<p>The article describes the outcomes of a single-centre investigation on the use of OZOILE to improve the healing process in patients with chronic diabetic ulcers. This is a non-randomised interventional study which aims to assess the differences between two groups (total 200 patients) by evaluating healing time at 15, 30, 45, 60, 75 and 90 days. Pain assessment with VAS scale at 15, 30 and 45 days, biofilm test and tissue regeneration by histological evaluation were also taken into consideration. The outcomes show faster healing, reduced pain, control of local infection, aesthetically pleasing and qualitatively better healing. Our treatment strategy involves applying OZOILE detergent without rinsing, Ozoile spray oil and Ozoile cream followed by a non-adherent dressing (paraffin gauze). This integrated protocol shows a safe and effective treatment for diabetic chronic wound healing in a cost-effective manner. The group treated with the Rigenoma/Ozoile protocol demonstrated significantly superior outcomes compared to the control group, including accelerated healing, reduced pain levels, effective management of unpleasant odour, and high levels of compliance from both patients and surgeons. Overall, Ozoile markedly reduced healing time compared with standard care, with results robust across multiple analytical approaches.</p>","PeriodicalId":14451,"journal":{"name":"International Wound Journal","volume":"22 11","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/iwj.70786","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145563896","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EPIFIX, a dehydrated human amnion/chorion membrane allograft, received regulatory approval as a medical device in 2021 by the Ministry of Health, Labour and Welfare following review by the Pharmaceuticals and Medical Devices Agency, for the treatment of refractory ulcers, including diabetic foot ulcers. Insurance reimbursement under the Japanese national health insurance system was approved in 2022. This study investigated the efficacy of EPIFIX for diabetic foot ulcers in Japan. This study included 55 patients who were treated with EPIFIX after debridement, evaluating the treatment duration and wound outcomes. Treatment was considered complete upon successful wound closure (i.e., reconstruction or epithelialization) or when adverse events (i.e., wound infection, death, or other complications) occurred. The wounds were classified as either healed or nonhealed. Wound healing was observed in 43 patients. Comparing the patients with healed and non-healed wounds, there was a significant difference in the presence of chronic kidney disease (G5d), coronary artery disease, and certain laboratory findings (albumin, C-reactive protein, white blood cell count, and haemoglobin) (p < 0.05). The treatment duration was similar between the healed and non-healed groups (24.39 vs. 24.83 days, p = 0.14). Wound bed preparation and an improved general health condition were key factors for healing. EPIFIX promotes wound healing in diabetic foot ulcers, although careful patient selection is essential to maximise its effectiveness.
{"title":"Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series","authors":"Yuta Terabe, Nobuhito Kaneko","doi":"10.1111/iwj.70787","DOIUrl":"10.1111/iwj.70787","url":null,"abstract":"<p>EPIFIX, a dehydrated human amnion/chorion membrane allograft, received regulatory approval as a medical device in 2021 by the Ministry of Health, Labour and Welfare following review by the Pharmaceuticals and Medical Devices Agency, for the treatment of refractory ulcers, including diabetic foot ulcers. Insurance reimbursement under the Japanese national health insurance system was approved in 2022. This study investigated the efficacy of EPIFIX for diabetic foot ulcers in Japan. This study included 55 patients who were treated with EPIFIX after debridement, evaluating the treatment duration and wound outcomes. Treatment was considered complete upon successful wound closure (i.e., reconstruction or epithelialization) or when adverse events (i.e., wound infection, death, or other complications) occurred. The wounds were classified as either healed or nonhealed. Wound healing was observed in 43 patients. Comparing the patients with healed and non-healed wounds, there was a significant difference in the presence of chronic kidney disease (G5d), coronary artery disease, and certain laboratory findings (albumin, C-reactive protein, white blood cell count, and haemoglobin) (<i>p</i> < 0.05). The treatment duration was similar between the healed and non-healed groups (24.39 vs. 24.83 days, <i>p</i> = 0.14). Wound bed preparation and an improved general health condition were key factors for healing. EPIFIX promotes wound healing in diabetic foot ulcers, although careful patient selection is essential to maximise its effectiveness.</p>","PeriodicalId":14451,"journal":{"name":"International Wound Journal","volume":"22 11","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12624360/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145540662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
<p>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 (<i>τ</i><sup>2</sup>), and Higgins' <i>I</i><sup>2</sup> statistic (<i>I</i><sup>2</sup>), 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 <i>n</i> = 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>I</i><sup>2</sup> = 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 pa
{"title":"Collagen–ORC Versus Standard Treatment in Diabetic Foot Ulcers: A Systematic Review and Meta-Analysis of Randomised Trials","authors":"George Theodorakopoulos, David G. Armstrong","doi":"10.1111/iwj.70782","DOIUrl":"10.1111/iwj.70782","url":null,"abstract":"<p>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 (<i>τ</i><sup>2</sup>), and Higgins' <i>I</i><sup>2</sup> statistic (<i>I</i><sup>2</sup>), 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 <i>n</i> = 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>I</i><sup>2</sup> = 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 pa","PeriodicalId":14451,"journal":{"name":"International Wound Journal","volume":"22 11","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12623144/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145540619","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Adéla Holubová, Niels A. J. Cremers, Martin Krause, Lada Cetlová, Jana Matějková, Andrea Pokorná
Hard-to-heal wounds are frequently associated with underlying conditions such as diabetes, vascular disease, and biofilm-related infections. Accurate identification of microbial origin is essential, but is often hindered by biofilms. This study evaluated whether sonication of wound dressings, combined with different sample transport methods, improves bacterial detection in venous leg ulcers. In a prospective observational case–control study, six patients with hard-to-heal venous leg ulcers received treatments with medical-grade honey (MGH) (n = 1), ceramic dressings – “Cerdak” (n = 2), or hydroactive dressings (n = 3). Three microbiological samples were collected per patient: (1) conventional wound swab (Levin's technique) in Amies medium; (2) sonicate fluid from used dressings transported in sterile tubes without medium; and (3) sonicate fluid in haemoculture tubes (BACT/ALERT). Total pathogen count and diversity were compared across sampling methods. Patient quality of life (QoL) was assessed using the Wound-QoL instrument. Sonication revealed additional pathogens not detected by conventional swabs. The highest number of pathogens was found in sonicate fluid transported in haemoculture tubes (n = 43), followed by swabs (n = 39) and sterile tube transport (n = 30). Adequate treatment significantly improved patients' QoL during the healing process. Dressing sonication, especially with haemoculture tube transport, enhances microbial identification and may improve diagnosis and management of hard-to-heal wounds.
{"title":"Testing Sonication and Different Transport Media to Enhance Microbial Detection in Hard-to-Heal Venous Leg Ulcers","authors":"Adéla Holubová, Niels A. J. Cremers, Martin Krause, Lada Cetlová, Jana Matějková, Andrea Pokorná","doi":"10.1111/iwj.70778","DOIUrl":"10.1111/iwj.70778","url":null,"abstract":"<p>Hard-to-heal wounds are frequently associated with underlying conditions such as diabetes, vascular disease, and biofilm-related infections. Accurate identification of microbial origin is essential, but is often hindered by biofilms. This study evaluated whether sonication of wound dressings, combined with different sample transport methods, improves bacterial detection in venous leg ulcers. In a prospective observational case–control study, six patients with hard-to-heal venous leg ulcers received treatments with medical-grade honey (MGH) (<i>n</i> = 1), ceramic dressings – “Cerdak” (<i>n</i> = 2), or hydroactive dressings (<i>n</i> = 3). Three microbiological samples were collected per patient: (1) conventional wound swab (Levin's technique) in Amies medium; (2) sonicate fluid from used dressings transported in sterile tubes without medium; and (3) sonicate fluid in haemoculture tubes (BACT/ALERT). Total pathogen count and diversity were compared across sampling methods. Patient quality of life (QoL) was assessed using the Wound-QoL instrument. Sonication revealed additional pathogens not detected by conventional swabs. The highest number of pathogens was found in sonicate fluid transported in haemoculture tubes (<i>n</i> = 43), followed by swabs (<i>n</i> = 39) and sterile tube transport (<i>n</i> = 30). Adequate treatment significantly improved patients' QoL during the healing process. Dressing sonication, especially with haemoculture tube transport, enhances microbial identification and may improve diagnosis and management of hard-to-heal wounds.</p>","PeriodicalId":14451,"journal":{"name":"International Wound Journal","volume":"22 11","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12620129/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145534491","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Irritant contact dermatitis is a common peristomal skin complication. Due to the continuous irritation from intestinal fluids and faeces, the healing of this dermatitis is slow and the condition severely impairs patients' quality of life. The study aimed to evaluate the efficacy of a modified insertable ostomy appliance in promoting healing and improving patient outcomes. A randomised controlled trial was conducted from January 2022 to December 2024 in a tertiary hospital. The enrolled patients, all diagnosed with irritant contact dermatitis, were randomly assigned to two groups. The control group wore the conventional two-piece ostomy appliance, while the experimental group wore the modified insertable ostomy appliance. Outcomes were assessed on Days 3, 7, 14 and 28. The primary outcome was the healing rate (Discoloration, Erosion and Tissue overgrowth [DET] score ≤ 2) at Day 28. Secondary outcomes included the DET score, Visual Analogue Scale (VAS) pain score, Stoma Quality of Life questionnaire (Stoma-QOL) score and the incidence of appliance leakage. A total of 89 eligible participants completed the trial. The experimental group showed a significantly higher 28-day healing rate (73.3% vs. 29.5%, p < 0.001), lower DET scores (Day 28: 2.0 vs. 4.5, p < 0.001), reduced VAS scores (Day 28: 1.5 vs. 2.0, p < 0.001), higher Stoma-QOL scores (Day 28: 55.67 vs. 51.64, p < 0.001) and lower leakage rate (13.3% vs. 93.2%, p < 0.001). The modified ostomy appliance significantly improves healing, reduces pain and enhances quality of life, representing a novel solution for clinical practice.
刺激性接触性皮炎是一种常见的皮肤并发症。由于肠道液体和粪便的持续刺激,这种皮炎愈合缓慢,严重影响患者的生活质量。该研究旨在评估改良的可插入式造口器在促进愈合和改善患者预后方面的功效。随机对照试验于2022年1月至2024年12月在某三级医院进行。所有被诊断为刺激性接触性皮炎的患者被随机分为两组。对照组使用传统的两片式造口器,实验组使用改良的可插入式造口器。在第3、7、14和28天评估结果。主要观察指标为第28天的愈合率(变色、糜烂和组织过度生长[DET]评分≤2)。次要结果包括DET评分、视觉模拟评分(VAS)疼痛评分、Stoma- qol评分和矫治器泄漏发生率。共有89名符合条件的参与者完成了试验。实验组28天愈合率显著提高(73.3% vs. 29.5%, p < 0.001), DET评分显著降低(第28天:2.0 vs. 4.5, p < 0.001), VAS评分显著降低(第28天:1.5 vs. 2.0, p < 0.001), Stoma-QOL评分显著提高(第28天:55.67 vs. 51.64, p < 0.001),渗漏率显著降低(13.3% vs. 93.2%, p < 0.001)。改良的造口器显著改善愈合,减轻疼痛,提高生活质量,为临床实践提供了一种新的解决方案。
{"title":"Application and Efficacy Evaluation of a Modified Ostomy Appliance in Managing Peristomal Irritant Contact Dermatitis: A Randomised Controlled Trial","authors":"Xiaoxiao Ying, Luqiao Huang, Feng Yu, Chan Xu","doi":"10.1111/iwj.70794","DOIUrl":"https://doi.org/10.1111/iwj.70794","url":null,"abstract":"<p>Irritant contact dermatitis is a common peristomal skin complication. Due to the continuous irritation from intestinal fluids and faeces, the healing of this dermatitis is slow and the condition severely impairs patients' quality of life. The study aimed to evaluate the efficacy of a modified insertable ostomy appliance in promoting healing and improving patient outcomes. A randomised controlled trial was conducted from January 2022 to December 2024 in a tertiary hospital. The enrolled patients, all diagnosed with irritant contact dermatitis, were randomly assigned to two groups. The control group wore the conventional two-piece ostomy appliance, while the experimental group wore the modified insertable ostomy appliance. Outcomes were assessed on Days 3, 7, 14 and 28. The primary outcome was the healing rate (Discoloration, Erosion and Tissue overgrowth [DET] score ≤ 2) at Day 28. Secondary outcomes included the DET score, Visual Analogue Scale (VAS) pain score, Stoma Quality of Life questionnaire (Stoma-QOL) score and the incidence of appliance leakage. A total of 89 eligible participants completed the trial. The experimental group showed a significantly higher 28-day healing rate (73.3% vs. 29.5%, <i>p</i> < 0.001), lower DET scores (Day 28: 2.0 vs. 4.5, <i>p</i> < 0.001), reduced VAS scores (Day 28: 1.5 vs. 2.0, <i>p</i> < 0.001), higher Stoma-QOL scores (Day 28: 55.67 vs. 51.64, <i>p</i> < 0.001) and lower leakage rate (13.3% vs. 93.2%, <i>p</i> < 0.001). The modified ostomy appliance significantly improves healing, reduces pain and enhances quality of life, representing a novel solution for clinical practice.</p>","PeriodicalId":14451,"journal":{"name":"International Wound Journal","volume":"22 11","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/iwj.70794","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145522083","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kim L. M. Gardien, Anouk Pijpe, Kelly Kwa, Martijn B. A. van der Wal, Wim E. Tuinebreijer, Esther Middelkoop
This study aimed to determine if skin types can be accurately assessed via melanin scores measured with a colormeter, and whether scar characteristics of people with different skin types are different at various stages of healing. Melanin scores of a Cortex DSM Colormeter were validated against the Fitzpatrick skin type questionnaire in healthy volunteers and unaffected skin of burn and scar patients (N = 137) to determine melanin index cut-offs per skin type. Scar quality in children and adults at 3, 6, and 12 months post-burn using DSM Colormeter and the Patient and Observer Scar Assessment Scale (POSAS) was analysed in a cohort of > 1000 patients. Data from 137 individuals showed good correlation between melanin index and Fitzpatrick skin types (Spearman's rho: 0.72 Dermaspectrometer, 0.69 DSM II; p < 0.0001). Scar characteristics varied by skin type for erythema, pigmentation, vascularization, and overall POSAS scores. Children had significantly thicker scars than adults, regardless of skin type, varying from 0.3 to 1.4 points difference on the observer scale at 12 months post burn. We conclude that skin type can be objectively classified using the melanin index, showing a strong correlation with the Fitzpatrick questionnaire. Skin type influences scar outcomes, especially pigmentation and vascularization. Children, particularly those with lighter skin, tend to develop thicker scars than adults. Recognising these differences can improve scar management and patient education.
这项研究旨在确定皮肤类型是否可以通过颜色计测量的黑色素分数来准确评估,以及不同皮肤类型的人在不同的愈合阶段是否有不同的疤痕特征。在健康志愿者和未受影响的烧伤和疤痕患者皮肤(N = 137)中,根据Fitzpatrick皮肤类型问卷验证皮质DSM色度计的黑色素评分,以确定每种皮肤类型的黑色素指数截止值。使用DSM色度计和患者与观察者疤痕评估量表(POSAS)对儿童和成人在烧伤后3、6和12个月的疤痕质量进行了分析。来自137个个体的数据显示黑色素指数与Fitzpatrick皮肤类型之间存在良好的相关性(Spearman’s rho: 0.72 Dermaspectrometer, 0.69 DSM II; p
{"title":"Scar Quality After Burns in Relation to Skin Type, Classified by Device-Based Colour Measurement, as an Alternative for the Fitzpatrick Questionnaire","authors":"Kim L. M. Gardien, Anouk Pijpe, Kelly Kwa, Martijn B. A. van der Wal, Wim E. Tuinebreijer, Esther Middelkoop","doi":"10.1111/iwj.70788","DOIUrl":"10.1111/iwj.70788","url":null,"abstract":"<p>This study aimed to determine if skin types can be accurately assessed via melanin scores measured with a colormeter, and whether scar characteristics of people with different skin types are different at various stages of healing. Melanin scores of a Cortex DSM Colormeter were validated against the Fitzpatrick skin type questionnaire in healthy volunteers and unaffected skin of burn and scar patients (<i>N</i> = 137) to determine melanin index cut-offs per skin type. Scar quality in children and adults at 3, 6, and 12 months post-burn using DSM Colormeter and the Patient and Observer Scar Assessment Scale (POSAS) was analysed in a cohort of > 1000 patients. Data from 137 individuals showed good correlation between melanin index and Fitzpatrick skin types (Spearman's rho: 0.72 Dermaspectrometer, 0.69 DSM II; <i>p</i> < 0.0001). Scar characteristics varied by skin type for erythema, pigmentation, vascularization, and overall POSAS scores. Children had significantly thicker scars than adults, regardless of skin type, varying from 0.3 to 1.4 points difference on the observer scale at 12 months post burn. We conclude that skin type can be objectively classified using the melanin index, showing a strong correlation with the Fitzpatrick questionnaire. Skin type influences scar outcomes, especially pigmentation and vascularization. Children, particularly those with lighter skin, tend to develop thicker scars than adults. Recognising these differences can improve scar management and patient education.</p>","PeriodicalId":14451,"journal":{"name":"International Wound Journal","volume":"22 11","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/iwj.70788","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145512686","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}