Diabetes and its associated complications is one of the biggest burdens that healthcare providers face. Diabetic foot ulcers (DFUs) are difficult-toheal wounds resulting from the diabetes-related pathogenic abnormalities.
Statistics from China are high, with the largest global prevalence of people with diabetes, and the local expenditure for this disease is second only to the US (Zhang et al, 2021). Moreover, 20% to 33% of costs related to diabetes mellitus are used for treatments of the diabetic foot (Chun et al, 2019). International and Chinese national guidelines broadly agree on the standard of care for the management of diabetic foot ulcers and it is very well understood that evidence-based holistic management, including local wound dressings, can improve healing outcomes. The clinical cases portrayed are aimed at describing the attainment of the implementation of Technology-Lipido-Colloid Nano-Oligosaccharide Factor dressing (TLC-NOSF). The TLC-NOSF dressing has been included in recent recommendations by the International Working Group on the Diabetic Foot (IWGDF) 2019 Guidelines and the National Institute for Health and Care Excellence (NICE, UK) and was the focus of a recently published systematic review highlighting the robust evidence behind this technology
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Australian Guideline on Wound Healing Interventions to Enhance Healing of Foot Ulcers Part of the 2021 Australian Evidence-Based Guidelines for Diabetes Related Foot Disease
Abstract
Background: Diabetes-related foot ulceration (DFU) has a substantial burden on both individuals and healthcare systems both globally and in Australia. There is a pressing need for updated guidelines on wound healing interventions to improve outcomes for people living with DFU. A national expert panel was convened to develop new Australian evidence-based guidelines on wound healing interventions for people with DFU by adapting suitable international guidelines to the Australian context.
Methods: The panel followed National Health and Medical Research Council (NHMRC) procedures to adapt suitable international guidelines by the International Working Group of the Diabetic Foot (IWGDF) to the Australian context. The panel systematically screened, assessed and judged all IWGDF wound healing recommendations using ADAPTE and GRADE frameworks for adapting guidelines to decide which recommendations should be adopted, adapted or
excluded in the Australian context. Each recommendation had their wording, quality of evidence, and strength of recommendation re-evaluated, plus rationale, justifications and implementation considerations provided for the Australian context. This guideline underwent public consultation, further revision and approval by ten national peak bodies.
A Prospective Study on the Efficacy of Sequential Treatment of Technology Lipido‐Colloid Impregnated with Silver and Technology Lipido‐Colloid Nano‐Oligosaccharide Factor in the Management of Venous Leg Ulcers
Background and Aims: Venous leg ulcers (VLUs) are associated with significant morbidity and poor quality of life (QOL). Compression therapy and wound dressing are the mainstay treatment options. Technology Lipido‐Colloid Impregnated with Silver (TLC‐Ag) reduces bacterial load and Technology Lipido‐Colloid Nano‐Oligosaccharide Factor (TLC‐NOSF) reduces elevated matrix metalloproteinases and improve wound healing. However, evidence is scarce on the role of sequential therapy. This study aims to evaluate if sequential treatment with TLC‐Ag and TLC‐ NOSF improves VLU wound healing and QOL.
Methods: This is a prospective cohort study from May 2020 to October 2021 on patients with VLUs who received sequential therapy, consisting of 2 weeks of TLC‐Ag followed by two‐layer compression bandage (2LB) with TLC‐NOSF until complete wound healing. Participants were followed‐up with weekly dressing changes. Our primary outcomes were wound area reduction (WAR) and Pressure Ulcer Scale of Healing (PUSH) score. Our secondary outcomes were QOL measures.
Results: There were 28 patients with 57.1% males (n = 16) with a mean age of 65.3 years. Mean duration of VLU was 13.9 ± 11.7 weeks before the initiation ofsequential therapy. Mean baseline wound area was 8.44 cm2
. Median time to wound healing was 10 weeks. 57.1% of patients achieved complete wound closure at3 months. There was significant WAR after 1 month (mean area 8.44–5.81 cm2 , 31.2% decrease) and after 3 months (mean area 8.44–2.53 cm2 , 70.0% decrease). Mean monthly WAR was 28.9%. PUSH score also decreased at 1 month (16.5% decrease, p < 0.001) and 3 months (63.3% decrease, p < .001) marks following the sequential therapy. EuroQol Visual Analog Scale (EQ‐VAS) improved following sequential therapy
(baseline: 69.0 ± 15.0, week 13: 80.2 ± 13.2, p < 0.001).
Conclusion: Sequential therapy with TLC‐Ag followed by TLC‐NOSF and 2LB is feasible, with good wound healing and improvement in QOL of patients with VLUs.
UK NICE 2023 MTG42 UrgoStart for treating diabetic foot ulcers and leg ulcers
Evidence-based recommendations on UrgoStart for treating diabetic foot ulcers and leg ulcers.
In April 2023, NICE updated section 1 to reflect the current format of NICE guidance. NICE also added some text to the clinical evidence section to summarise new clinical evidence reviewed. NICE’s recommendations for UrgoStart remain unchanged. More details are in the review decision. New text is marked [2023].
NICE medical technologies guidance addresses specific technologies notified to NICE by sponsors. The ‘case for adoption’ is based on the claimed advantages of introducing the specific technology compared with current management of the condition. This case is reviewed against the evidence submitted and expert advice. If the case for adopting the technology is supported, then the technology has been found to offer advantages to patients and the NHS. The specific recommendations on individual technologies are not intended to limit use of other relevant technologies which may offer similar advantages.
This guidance replaces NICE medtech innovation briefing on UrgoStart for chronic wounds (MIB82).
Clinical Evaluation of a Dressing with Poly-Absorbent Fibres and a Silver Matrix for Managing Chronic Wounds at Risk of Infection A Non-Comparative Trial
Objective: To assess the efficacy, safety and acceptability of a new
silver poly absorbent dressing (UrgoCleanAg) in the local management
of exudative chronic wounds at risk of infection, with inflammatory
signs suggesting heavy bacterial load.
Method: This prospective, multicentre, non-comparative clinical trial
was conducted in French hospital wards (dermatology and vascular
medicine) or specialised private-practice physicians. Patients were
considered at high-risk of infection when presenting with at least three
of five selected inflammatory clinical signs, suggesting a heavy
bacterial load (pain between two dressing changes, erythema, oedema,
malodorous wound and presence of a heavy exudate). They were
treated for a maximum period of four weeks, and followed by the
physician on a weekly basis, including a clinical examination, area
tracings and photographs. The primary efficacy criterion of the trial was
the relative wound surface area reduction at the end of the four weeks
of treatment. Acceptability was documented by the nursing staff at
each dressing change between the weekly evaluations.
Results: We recruited 37 patients with chronic wounds. Wound
surface area, mostly covered by sloughy tissue, was reduced by 32.5%
at the end of the treatment (median value), while the clinical score
(maximum value of 5, based on inflammatory clinical signs) decreased
from 4.0 to 2.0. Effective debridement properties were documented
(62.5% relative reduction of sloughy tissue at week 4; 58.8% of
debrided wounds at week 4) and improvement of the periwound skin
status was noted (healthy for 28.6% of the patients at week 4 versus
2.7% at baseline). In addition, the tested wound dressing presented a
good safety profile associated to a high level of acceptability, noted by
both patients and nursing staff.
Conclusion: These clinical data support that the tested dressing is a
credible therapeutic alternative for the management of chronic
wounds at risk of infection with inflammatory signs suggesting heavy
bacterial load.
Declaration of interest: This study was sponsored by a grant from
the pharmaceutical company Laboratoires Urgo. S. Bohbot and Z.
Lemdjadi are employees of Laboratoires Urgo. L. Sigal has received
monetary compensation as a speaker for Laboratoires Urgo. Data
management and statistical analyses were conducted independently
by Altizem.
Practical Guidelines on the Prevention and Management of Diabetes-Related Foot Disease IWGDF 2023 Update
Diabetes-related foot disease results in a major global burden for patients and the healthcare system. The International Working Group on the Diabetic Foot (IWGDF) has been producing evidence-based guidelines on the prevention and management of diabetes-related foot disease since 1999. In 2023, all IWGDF Guidelines have been updated, based on systematic reviews of the literature and formulation of recommendations by multidisciplinary experts from all over the world. In addition, a new guideline on acute Charcot neuro-osteoarthropathy was created. In this document, the IWGDF Practical Guidelines, we describe the basic principles of prevention, classification and management of diabetes-related foot disease, based on the seven IWGDF Guidelines. We also describe the organizational levels to successfully prevent and treat diabetes-related foot disease according to these principles and provide addenda to assist with foot screening. The information in these practical guidelines is aimed at the global community of healthcare professionals who are involved in the care of persons with diabetes. Many studies around the world support our belief that implementing these prevention and management principles is associated with a decrease in the frequency of diabetes-related lower-extremity amputations. The burden of foot disease and amputations is increasing at a rapid rate, and comparatively more so in middle to lower income countries. These guidelines also assist in defining standards of prevention and care in the these countries. In conclusion, we hope that these updated practical guidelines continue to serve as a reference document to aid healthcare providers in reducing the global burden of diabetes-related foot disease.
Use of a TLC-Ag dressing on 2270 patients with wounds at risk or with signs of local infection an observational study
Objective: A description of wounds treated with a poly-absorbent silver dressing (with technology lipido-colloid with silver ions, TLC-Ag), and evaluation of the short-term clinical impact of the dressing on the wound healing process, under real-life conditions.Method: A large, prospective, multicentre, observational study of patients in 81 centres in Germany, presenting with an exuding wound at risk or with clinical signs of local infection for whom the evaluated TLC-Ag dressing (UrgoClean Ag, Laboratoires Urgo, France) has been prescribed. Main outcomes included: reduction in number of wound infections diagnosed and clinical signs of local infection, wound healing rate, clinical assessment of wound healing progression, relative wound area reduction (RWAR), local tolerability, handling and acceptance of the dressing.Results: A total of 2270 patients with acute and chronic wounds of various aetiologies were treated with the evaluated dressing for a mean duration of 22±13 days. All clinical signs of local infection and the diagnosed wound infections were substantially reduced at two weeks after the treatment initiation. All wound infection parameters continued to reduce until the last visit. In the meantime, clinical improvement in wound healing was reported in 98.9% of acute wounds, with a wound closure rate of 68.5%. In chronic wounds, a median RWAR of 57.4% was achieved, with an improvement in healing process documented by clinicians in 90.6% of cases, stabilisation in 6.1% and worsening in 3.2%. Similar results were reported, regardless of exudate level and proportion of sloughy and granulation tissues in the wound bed at baseline. The dressing was well tolerated and well accepted by both patients and health professionals.Conclusion: These results, documented in a large cohort of patients treated in current practice, support and complete the clinical evidence on the healing properties and safety prole of the TLC-Ag dressing in the management of wounds at risk or with clinical signs of local infection, regardless of wound and patient characteristics.Declaration of interest: This study was supported by a grant from Laboratoires Urgo. UM, EB, LT and SB are employees of Laboratoires Urgo. JD, KCM and MD provided advisory and speaking services to pharmaceutical and other healthcare organisations including, but not limited to, Laboratoires Urgo. Data management and statistical analyses were conducted independently by INPADS GmbH, Germany
The Impact of Patient Health and Lifestyle Factors on Wound Healing, Part 1 Stress, Sleep, Smoking, Alcohol, Common Medications and Illicit Drug Use
This document sets out to understand the prevalence of various health and chronic illness risk factors among those with chronic wounds and how those factors influence healing.
Part 1 provides background information on population health and identifies the risk factors for chronic illnesses that are the focus of this document. Factors including stress, sleep, smoking, medication, illicit drug use and alcohol consumption are explored, all commencing with an understanding of pathophysiology as it relates to wound healing, followed by a review of the literature as it applies to chronic wounds. Evidence of interventions at the level of randomised controlled trials (RCTs) to manage these factors and their impact on wound prevention or treatment is limited and thus we will refer to systematic reviews, observational studies and in vitro studies as appropriate.
TLC-Ag dressings a prospective, multicentre study on 728 patients with wounds at risk of or with local infection
Objective:This study aimed to evaluate the management of an unselected cohort of patients with wounds at risk of or with clinical signs of local infection, treated with two antimicrobial contact layers impregnated with silver (TLC-Ag healing matrix), under real-life conditions during the COVID-19 pandemic.
Method:A large, prospective, multicentre, observational study with two TLC-Ag dressings (UrgoTul Ag/Silver and UrgoTul Ag Lite Border, Laboratoires Urgo, France) was conducted in Germany between May 2020 and May 2021. The main outcomes included a description of the treated patients and their wound management, the changes in wound infection and wound healing outcomes over a maximum period of four weeks of treatment, as well as the overall clinical assessment of the performance, local tolerance and acceptability of dressings.
Results:A total of 728 patients with wounds of various aetiologies and wound infection status were treated with the evaluated dressings in 39 centres for a mean duration of 26±19 days, with an intermediate visit conducted in 712 (97.8%) patients after a mean period of 12±9 days. At the initial visit, it was established that the majority of patients (60.4%) had a wound infection, while the remaining cohort presented first clinical signs of a local wound infection (25.1%) or were at risk of wound infection (13.2%) (unclear status in 1.2%). Throughout the study period, all the parameters of wound infection continuously decreased, resulting at the final visit in a reduction by 78.9% of the prevalence of local wound infections and by 72.0% of the clinical signs of wound infection, the most rapidly diminished clinical sign being wound deterioration. Concurrently, in terms of the healing process, 92.1% of the wounds healed or improved, 3.2% remained unchanged and 1.7% worsened (data missing for 3.0%), and an improvement of the periwound skin was reported in 65.7% of the patients. Overall, the two dressings were ‘very well accepted’ by the majority of patients, with no uncomfortable feeling at wearing and no pain at dressing removal, and were assessed by the physicians as ‘very useful’ in the majority of the cases with a ‘very good’ efficacy in terms of antimicrobial activity and promotion of the wound healing process. Similar results were reported regardless of the wound type treated or of the TLC-Ag dressing evaluated.
Conclusion:These results are consistent with previous clinical evidence on TLC-Ag dressings. They support the good efficacy, good tolerability and usefulness of these antimicrobial dressings in the management of patients with wounds at risk or with clinical signs of local infection, in association with appropriate standard of care.
The Impact of Patient Health and Lifestyle Factors on Wound Healing, Part 2 Physical Activity and Nutrition
Part two of the EWMA document ‘The impact of patient health and lifestyle factors on wound healing’ focuses on two factors: physical activity and nutrition. In this paper, the pathophysiological understanding of how physical activity and nutrition either increase the risk for wounding or impact the healing process will be presented. We review current evidence for the effectiveness of interventions in improving healing outcomes and offer some recommendations for practice and further research. This part of the document should be read in conjunction with Part 11, which discussed stress, sleep, smoking, illicit drug use and alcohol misuse and described how some commonly used medications impact the healing process.