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AnteayerInternational Wound Journal

Negative Pressure Wound Therapy Use: Recommendations and Insights From a Middle Eastern Panel of Experts

ABSTRACT

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.

Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series

ABSTRACT

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.

Predictors of Post‐Amputation Complications in Major Lower Limb Amputations: The Role of WIfI Scoring and Pre‐Amputation Transcutaneous Oximetry (TcPO2)

ABSTRACT

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.

Clinical Outcomes and Characterisation of the Autologous Adipose Tissue Harvested With Superficial Enhanced Fluid Fat Injection Method for Treatment of Diabetic Foot Ulcer Undergoing Minor Amputation (SEFFIDiFA Trial)

ABSTRACT

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.

Negative Pressure Wound Therapy With Instillation and Closed Incision Negative Pressure Therapy Use in South Africa: Expert Panel Recommendations

ABSTRACT

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.

Human Placenta‐Derived Cells (PDA‐002) in Diabetic Foot Ulcer Patients With and Without Peripheral Artery Disease: A Phase 2 Multi‐Center, Randomised, Double‐Blind, Placebo‐Controlled Trial

ABSTRACT

The management of diabetic foot ulcers in patients with peripheral artery disease remains challenging. Human placenta-derived cells (PDA-002), a mesenchymal stromal cell-like population obtained from full-term placental tissue, possess angiogenic and tissue regenerative properties. Participants were stratified based on peripheral artery disease status. A total of 159 individuals were randomly assigned to receive intramuscular PDA-002 at one of three doses (3 × 106, 10 × 106 and 30 × 106 cells) or a placebo. This Phase 2 multi-center, randomised, double-blind, placebo-controlled trial evaluated adults with chronic diabetic foot ulcers with and without peripheral artery disease. The primary efficacy endpoint was the proportion of participants achieving complete wound closure of the index ulcer within 3 months, with sustained closure maintained for an additional 4 weeks. PDA-002 was well-tolerated, with no treatment-related serious adverse events. Intramuscular PDA-002 treatment achieved the highest efficacy at the 3 × 106 cell dose within the peripheral artery disease subgroup (38.5% vs. 22.6% for placebo), meeting a stringent 4-week durability endpoint that surpassed the U.S. Food and Drug Administration's recommended 2-week sustainability criterion. PDA-002 shows promise as a breakthrough treatment for diabetic foot ulcers and peripheral artery disease, demonstrating efficacy with two intramuscular doses and no re-treatment.

Trial Registration: ClinicalTrials.gov identifier: NCT # 02264288

A Borate‐Based Bioactive Glass Advances Wound Healing in Non‐Healing Wagner Grade 1 Diabetic Foot Ulcers: A Randomised Controlled Clinical Trial

ABSTRACT

A novel advanced synthetic bioactive glass matrix was studied in patients with non-healing diabetic foot ulcers (DFUs). Bioactive glasses can be constructed to be biocompatible, with water-soluble materials in multiple geometries including fibre scaffolds that mimic the 3D architecture of a fibrin clot. In this trial, chronic, Wagner Grade 1 DFUs were randomised to receive borate-based bioactive glass Fibre Matrix (BBGFM) plus standard of care (SOC) therapy for 12 weeks or SOC alone. The primary study endpoint was the proportion of subjects that obtained complete wound closure at 12 weeks. Secondary endpoints included time to achieve complete wound closure at 12 weeks. In the modified intent-to-treat (mITT) analysis, 48% (32/67) treated with BBGFM plus SOC healed at 12 weeks compared to 24% (16/66) with SOC alone (p = 0.007). In the per protocol (PP) population, 73% (32/44) of subjects treated with BBGFM plus SOC healed versus 42% (16/38) in the SOC group (p = 0.007). Based on the success of this trial, BBGFM demonstrates faster healing of DFUs compared to SOC and should be considered in the treatment armamentarium for Wagner Grade 1 DFUs. Future trials should investigate the use of BBGFM for healing deeper chronic DFUs, other wound aetiologies, or complex surgical wounds.

Educational Interventions for Medical Students in Chronic Wound Care—A Scoping Review

ABSTRACT

Wound care education is underrepresented in medical students' curricula. This scoping review aims to provide an overview of the published literature on educational methods and interventions used for chronic wound care education, specifically for medical students. A five-step framework for scoping reviews was used and includes a specific research question, identification of relevant literature, selection of studies, extraction of data and synthesis of the results. In total, six electronic databases (PubMed, Cochrane Library, Embase (Ovid), Web of Science, Scopus and APA PsychInfo) were searched with pre-defined search terms. The selection and evaluation of studies were conducted in a blinded review by three independent reviewers. The review was carried out in accordance with the PRISMA-ScR checklist for scoping reviews. We identified nine suitable studies regarding educational interventions for medical students in wound care. The included papers showed a broad variety of educational approaches, such as online learning tools or hands-on skills training. The implemented interventions had a positive effect on the students' wound care knowledge and their ability to perform wound care-related clinical skills. There is no comparison of the effectiveness of the different interventions, and it is not evaluated how effective they are compared to traditional lectures. There remains a need for more wound care education with a focus on the needs of medical students.

African Medicinal Plants in Cutaneous Wound Repair: A Comprehensive Analysis of the Role of Phytochemicals

ABSTRACT

Chronic and non-healing wounds are a global health issue with limited effective treatments. Wound care costs continue to rise, highlighting the need for new therapies. Medicinal plants, particularly African species, show promise for enhancing wound healing. This review analysed 93 studies and identified 37 relevant to wound healing, covering 39 plant species. Ten species were identified for their rich phytochemical content, specifically flavonoids, terpenoids, and alkaloids (plant-derived compounds). These compounds act synergistically, enhancing the wound healing process at each stage. Flavonoids reduce inflammation and support tissue turnover, while terpenoids enhance collagen production and wound closure. Alkaloids offer antimicrobial benefits and support wound contraction. Notable plants include Ageratum conyzoides and Aspilia africana (Asteraceae family); promoting haemostasis by lowering plasma fibrinogen and enhancing platelet-derived growth factors; Withania somnifera (Solanaceae); and Entada africana (Fabaceae), effectively regulating inflammation. In the proliferative phase, Ocimum gratissimum (Lamiaceae), Calendula officinalis (Asteraceae), and Centella asiatica (Apiaceae) although C. officinalis is native to Southern Europe, and C. asiatica an Asian-native; they are widely used in African traditional medicine and included here for their relevance in African wound healing practices; Justicia flava (Acanthaceae), Alternanthera sessilis (Amaranthaceae), and Acalypha indica (Euphorbiaceae); play key roles in enhancing collagen production, angiogenesis, and re-epithelialisation. This comprehensive analysis highlights the role of African medicinal plants in wound healing and their potential to improve wound care therapy.

A Comprehensive Scoping Review on the Use of Point‐Of‐Care Infrared Thermography Devices for Assessing Various Wound Types

ABSTRACT

This scoping review investigates the use of point-of-care infrared thermography devices for assessing various wound types. A comprehensive search across four databases yielded 76 studies published between 2010 and 2024 that met the inclusion criteria. The review highlights thermography applications in burns, surgical wounds, diabetic foot ulcers, pressure injuries, and other lower limb wounds. Key findings indicate its effectiveness in detecting early signs of inflammation and healing delays, facilitating timely interventions. The technology shows promise in accurately predicting wound healing trajectories and assessing treatment outcomes. Recent advancements have made thermographic devices more affordable and user-friendly, expanding their clinical potential. However, challenges persist, including reimbursement, training requirements, and integration with electronic medical records (EMRs), with EMR integration identified as a critical barrier to widespread adoption. While preliminary findings are promising, the current evidence base is constrained by small sample sizes, retrospective study designs, and limited consideration of skin tone variability. Large, prospective studies are essential to validate the clinical utility of thermography in wound care and to inform the development of standardised protocols that support equitable, bias-reduced assessment across diverse populations. Addressing these gaps is critical for advancing research, enhancing clinician training, and improving patient outcomes in wound care. Overall, point-of-care thermography demonstrates significant potential to enhance wound assessment and monitoring, thereby elevating care quality and patient outcomes.

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