Conectar
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.
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.
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.
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.
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.
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.
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.
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.
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.
This study evaluates the predictive value of the WIfI (Wound, Ischemia, and foot Infection) classification system and pre-amputation transcutaneous oxygen pressure (TcPO2) measurements in forecasting post-amputation complications in major lower limb amputations (MLLA). A retrospective analysis was conducted on 132 MLLA patients with complete WIfI data and 87 patients with documented TcPO2 values. Associations between WIfI stage, TcPO2, and post-amputation outcomes—including healing time, surgical revisions, re-amputation, and wound complications—were assessed using statistical modeling and receiver operating characteristic (ROC) curve analyses. Higher WIfI stages correlated with prolonged healing (WIfI 4 failure rate: 12.8%) but did not significantly predict complications. Unexpectedly, WIfI 2 patients had a 4.4-fold higher risk of revision (p = 0.011) and a 3.1-fold higher re-amputation risk (p = 0.033) compared to WIfI 4. TcPO2 levels showed a significant relationship with healing outcomes, with a 36.9% failure rate in TcPO2 < 15 mmHg. A TcPO2 cut-off of > 46 mmHg optimized healing prediction (HR = 2.81, p = 0.004). TcPO2 is a stronger predictor of post-amputation complications than WIfI staging. A cut-off of > 46 mmHg at the amputation site is recommended to improve healing outcomes.
Diabetic foot ulcers (DFUs) are severe complications of diabetes that often lead to major amputations. Despite care advancements, approximately 50% of minor amputations do not heal, resulting in major amputations and increased mortality. This study evaluated the effectiveness of adipose-derived stem cells (ASCs) obtained through superficial enhanced fluid fat injection (SEFFI) in improving healing rates after minor amputations in DFUs. It was a prospective, single-arm, observational cohort study. The patients were monitored for half a year using monthly assessments. The primary endpoint was the healing rate of the amputation stumps after minor amputations coupled with ASC injections. Secondary endpoints included safety, feasibility, adverse events and analysis of variables associated with healing including the analysis of the injected mesenchymal adipose stem cell populations. Of the 256 screened patients, 40 were enrolled. At 6 months, 55% of the treated stumps had healed completely. The median healing time was 69 days. Technical success was achieved in all cases without device-related complications. Multivariable Cox models identified haemodialysis, opioid use and the injected number of CD45-positive cells as risk factors for healing failure. CD73 expression was positively associated with healing. The SEFFIDiFA trial demonstrated a promising 69% healing probability at 6 months post-amputation. This minimally invasive approach showed a higher healing rate with fewer complications. This study supports the potential of ASCs in enhancing wound healing in DFUs and highlights the importance of CD73 expression for successful outcomes. Further research is warranted to validate these findings and optimise the technique.
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.
The healthcare landscape in South Africa is challenging with a complex patient population and a stressed healthcare system. Negative pressure therapy-based systems such as negative pressure wound therapy with instillation and dwell (NPWTi-d) and closed incision negative pressure therapy (ciNPT) can help manage wounds or incisions. However, guidelines for South Africa-specific use are limited. An in-person meeting was held with 10 experts to develop South Africa-specific therapy use recommendations for NPWTi-d and ciNPT. Panel members recommended NPWTi-d use for wounds in need of cleansing. Normal saline and a 10-min dwell time were recommended with the caveat that the instillation solutions and dwell times can be changed based on the wound bed condition and the features of the instillation solution. A negative pressure cycle of 2–3 h and a negative pressure of −125 mmHg were also recommended for NPWTi-d. In patients, incisions, and surgical procedures at high risk of developing surgical site complications, ciNPT use was recommended. These general recommendations serve as a framework for NPWTi-d and/or ciNPT use in South Africa and should be updated as more region-specific evidence becomes available.
Use of synthetic drugs for the treatment of burn wounds has decreased due to adverse effects, and they are gradually being replaced by compounds obtained from natural products, especially medicinal plants. This review focused on pre-clinical and clinical studies examining the efficacy of medicinal plants in promoting burn wound healing. This systematic review was performed congruent with the guidance delineated in the PRISMA statement. Databases such as PubMed, Scopus, Embase and Web of Science, along with the search engines Google Scholar and Google, were utilised to retrieve published literatures from 2000 to 2023. Articles were screened according to the determined criteria and appraised using primary evaluation checklists. A total of 108 published articles met the eligibility criteria and were selected for discussion. Of these, 72 were in vivo studies, 28 were in vitro studies and 8 were clinical trials. Various medicinal plants discussed in this review improve the burn wound healing process due to the presence of diverse biological compounds with antioxidant, anti-inflammatory and antibacterial properties. These plants affect the four phases of wound healing. These plant species and their compounds could be potentially used for the development of effective natural remedies against burn wounds.
The aim of this study was to assess the performance and safety of daily treatment with a 0.2% hyaluronic acid-based hydrogel (Hyalo4 Skin Gel) in patients with chronic and acute wounds. The primary endpoint was the amelioration rate after 14 days of treatment, defined as the percentage of patients showing improvement in at least one of the following wound characteristics: wound tissue type, exudate amount, or type. Secondary endpoints included assessments of the treatment's effects on wound bed type, exudate amount and type, and patients' quality of life (EQ-5D QoL), as well as its safety and ease of application. Data were collected up to 56 days of treatment. A total of 170 patients were enrolled. Wound bed amelioration was observed in 46.0% of the patients after 14 days. The amelioration rate increased from 0.291 after 7 days to 0.561 after 56 days. The treatment promoted wound healing, increased granulation tissue formation, and normalized exudate levels. Additionally, QoL significantly improved, and the product was deemed easy to apply and safe, with no serious treatment-related adverse events reported. Being effective in enhancing the re-epithelialization of both acute and chronic wounds, Hyalo4 Skin Gel emerges as a promising strategy, improving clinical outcomes across a wide range of patients.
This integrative review aimed to describe the postoperative wound care practices and knowledge of nurses in acute care settings. Whittemore and Knafl's framework was used to identify and synthesise relevant studies. Full-text, primary articles published after 2000, focusing on postoperative wound care by nurses in hospital settings, were included. Quality appraisal was undertaken using the Mixed Methods Appraisal Tool (MMAT) for qualitative and quantitative studies and the Standards for QUality Improvement Reporting Excellence (SQUIRE) 2.0 for quality improvement (QI) studies. Five databases were searched (MEDLINE, Scopus, CINAHL, Embase and Web of Science) in August 2024. Of the 5329 studies, 36 articles were included. Inductive content analysis was used for data synthesis. Three categories were identified: Variation in using a holistic approach impacts optimal wound care practice, nurses' surgical wound care practices are shaped by individual factors, organisational support, and resource availability, and nurses' participation in surgical wound care is influenced by role clarity and multidisciplinary collaboration. In conclusion, this integrative review highlights that acute care nurses predominantly focused on technical dressing procedures with limited emphasis on comprehensive assessment, documentation, nutrition and patient education. Therefore, adopting a more holistic approach in surgical wound care could minimize practice variations among nurses.
This prospective, double-blind controlled trial was conducted to determine the effect of silicone gel in the reduction of postoperative scar after bilateral inguinal varicocelectomy. Thirty-four patients were enrolled in this study; the right-side inguinal scar was treated with silicone gel and petroleum jelly (Vaseline) applied on the left side as a placebo for 60 consecutive days. Scars were evaluated using the Vancouver Scar Scale, pruritus and pain. The result of this study showed that silicone gel was effective in the regression of postoperative scar after microscopic inguinal varicocelectomy in five key parameters, including vascularity, pigmentation, pliability, height and pruritus in comparison to placebo application (p < 0.05), while its effect on pain was insignificant (p > 0.05). The study showed that silicone gel had a considerable effect in the treatment and management of postoperative scar management. Varicocele is a condition that is considered the most common cause of male infertility. While microscopic inguinal varicocelectomy is considered a gold standard in the management of varicocele, its postoperative complications, such as scar formation remain a concern. Recent studies show that silicone gel can be an effective non-invasive treatment for scar regression. Accordingly, we designed this trial to evaluate the effect of silicone gel after microscopic inguinal surgery. A prospective double-blind controlled trial was conducted on 34 patients who had microscopic bilateral inguinal varicocelectomy (their age ranged from 19 to 41) at Namazi hospital. Two weeks after surgery, each patient received two identical tubes for application on the scars, the first tube containing silicone gel and the second one dispensed with petroleum jelly (Vaseline). The right side was treated with silicone gel, and the left side with Vaseline twice daily for 60 days. Then, patients were evaluated three times: firstly 2 weeks after surgical repair; second appointment after 2 months and third one after 6 months after surgery, using the Vancouver Scar Scale, pruritus and pain score. The collected data were analysed in SPSS 26, using the chi-square and Mann–Whitney U tests. The significance level was defined at p < 0.05. This study showed that silicone gel was highly effective in scar parameters, including pliability, height, vascularity pruritic and pigmentation. However, its effect on pain reduction was not significant (p > 0.05). The results of the study indicated that silicone gel effectively improved scar characteristics following microscopic inguinal varicocelectomy, while its efficacy against pain was not significant.
This study aimed to gain clinician consensus on which signs/symptoms reported to be indicative of biofilm in chronic wounds are likely to be so. An international, two-round eDelphi process including wound care clinicians ran from December 2023 to February 2024. Participants rated 26 items on a 9-point Likert scale. Consensus to include: ≥ 70% of respondents rate an item 7–9, ≤ 15% rate it 1–3. Consensus to exclude: ≥ 70% of respondents rate an item 1–3, ≤ 15% rate it 7–9. Eleven items (visual indicators [a shiny, slimy, persistent layer, easily removed, returns quickly without frequent intervention]; failure to respond to antimicrobials; infection > 30 days duration; poor quality granulation tissue; stalled wound despite optimal management; persistent/prolonged inflammation; wound > 6 weeks duration; soft tissue deterioration despite antimicrobials/debridement; signs of local infection; tunnelling/undermining; presence of slough) achieved consensus to include status. To our knowledge, consensus work on this topic has not previously been performed on such a wide scale. When examined alongside similar work, clinical opinion on the matter lacks coherence. We hope that these findings will help direct us toward greater cohesiveness. The work supports a need for research to quantify the predictive abilities of signs and symptoms reported to be indicative of biofilm in chronic wounds.
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