Chronic wounds are a perennial problem in clinical practice and place a burden
on patients, their families and healthcare providers. By addressing factors that
contribute to chronicity (slough, biofilm, elevated levels of metalloproteinases
and impaired angiogenesis), in addition to managing a patient’s comorbidities,
nutritional status and lifestyle, there is a greater chance of healing. This article
discusses the mechanisms by which UrgoClean Ag and UrgoStart support a
healthy wound environment, along with two case studies of their use in practice.
Archives
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).
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.
Evaluation of the Nanooligosaccharide Factor Lipido-Colloid Matrix in the Local Management of Venous Leg Ulcers Results of a Randomised, Controlled Trial
The nano-oligosaccharide factor (NOSF) is a new compound aiming to promote wound closure mainly through inhibition of matrix metalloproteinase (MMP) activity. This factor is incorporated within a lipido-colloid matrix (Techonology Lipido-Colloid-NOSF matrix) and locally released in the wound. The objective of this study was to document the performance (non inferiority or superiority) of the NOSF relative to the Promogran® matrix (oxidised regenerated cellulose, ORC) effect in the local management of venous leg ulcers (VLUs). This was a 12-week, open, two-arm, multicentre, randomised study. Patients were selected if the area of their VLU [ankle brachial pressure index ≥ 0.80] ranged from 5 to 25 cm2 with a duration≥3 months.
Ulcers had to be free from necrotic tissue. In addition to receiving compression bandage therapy, patients were randomly allocated to either NOSF matrix or ORC treatment for 12 weeks. The VLUs were assessed on a weekly basis and wound tracings were recorded. Percentage wound relative reduction (%RR) was the primary efficacy criterion. Secondary objectives were wound absolute reduction (AR), healing rate (HR) and % of wounds with≥ 40% reduction compared with baseline. A total of 117 patients were included (57 NOSF matrix and 60 ORC). Mean population age was 71.3 ± 13.5 years, body mass index was ≥ 30 kg/m2 in 39.3% and 15.4% were diabetics. Fifty-six per cent of the VLUs were present for >6 months, 61% were recurrent and 68%were stagnating despite appropriate care. Mean wound area at baseline was 11.2 ± 7.4 cm2. At the last evaluation, mean difference between the groups for %RR was 33.6 ± 15.0% in favour of NOSF matrix with a unilateral 95% confidence interval (CI) lower limit of 8.6% not including the null value. Therefore, a superiority of NOSF matrix effect compared with ORC was concluded (P= 0.0059 for superiority test). The median of the wound area reduction was 61.1% and 7.7% in the NOSF matrix and control groups, respectively (per-protocol analysis), or 54.4% versus 12.9% in intent-to-treat analysis (p =0.0286). Median AR was 4.2 cm2 in the NOSF group and 1.0 cm2 with ORC (P = 0.01). Median HR was -0.056 and -0.015 cm2/day in NOSF and ORC groups, respectively (P = 0.029). By logistic regression, the NOSF versus control odds ratio to reach 40% area reduction was 2.4 (95% CI: 1.1 – 5.3; P = 0.026). In the oldest and largest VLUs, a strong promotion of healing effect was particularly observed in the NOSF matrix group compared with the control group. NOSF matrix is a very promising option for the local management of chronic wounds, especially for VLUs with poor healing prognosis.
World Union of Wound Healing Societies Evidence in Wound Care
Wound management research improves patient care and clinical
outcomes by standardising assessment, planning and implementation
of treatment. In the field of wound care, high-level evidence is
possible, but it can be difficult to conduct due to the wide-ranging
nature of wounds and patients.
Additionally, there is an ever-growing variety of products and devices available to practitioners to improve healing rates and patient outcomes. In many cases, these products have enabled practitioners to heal more complex wounds and manage more
challenging and difficult cases. However, practitioners must be able to critically appraise evidence to make appropriate and effective evidence-based changes to practice.
UrgoStart Plus in Real Life
The prevalence of patients with chronic wounds continues to grow year-on-year and this places a substantial burden on health care resources. It is estimated that the NHS treats more than 2.2 million wounds annually, equating to 4.5% of the adult population, and the total cost of managing these wounds and associated co-morbidities is calculated to be £5.3 billon per year (Guest et al, 2015). However, it has been recognised that there are considerable unwarranted
variations in wound care services across the UK and that standardising practices offers opportunities to improve healing rates, reduce patient suffering and provide cost efficiencies
(NWCSP, 2020). In 2019 the National Institute for Health and Care Excellence published medical technologies guidance in relation to the UrgoStart treatment range. The committee reviewed five empirical
research papers, three of which were randomised controlled clinical trials. The committee critically appraised the publications and concluded that there was evidence to support the case
for adopting the UrgoStart treatment range to treat patients with diabetic foot ulcers and venous leg ulcers in the NHS, as the use of the UrgoStart treatment range was found to be associated
with increased rates of wound healing when compared with non-interactive dressings. Furthermore, they suggested that using the UrgoStart treatment range as part of the overall
management of diabetic foot ulcers and venous leg ulcers could reduce costs for the NHS.
Evaluation of NOSF in Neuropathic Diabetic Foot Ulcers
Both case studies feature neuropathic patients who have good lower limb arterial blood flow and there is an expectancy these wounds will heal. However, it is the speed of healing that is interesting, as well as the fact
that these wounds were progressed from a non/slow-healing state into a healed state. Of particular interest is the fact that Case Study 1 healed without the use of adequate pressure relief (the patient was non-compliant with the use of an Aircast boot). Pressure relief is an integral part of wound healing (NICE, 2004) and this factor alone could have been the cause of non-healing. Since the wound healed despite pressure relief not being adequate, this would indicate that, in this case, Urgostart Contact dressing was effective.UrgoStart Contact can be used effectively in the management of neuropathic diabetic foot wounds, however, the author has not been involved in case studies that demonstrate its effectiveness on diabetic neuroischaemic wounds.
Use of Nano-Oligosaccharide Factor (Sucrose Octasulfate) Dressing Based on Technology Lipido-Colloid (TLC-NOSF) as an Interface Layer with Negative Pressure Wound Therapy
Complex and complicated wounds (CCWs) tend to exhibit slow wound healing and poor prognoses despite good standards of care. Numerous literature demonstrated the efficacy of TLC-NOSF dressing (UrgoStart®) in healing of both acute and chronic wounds. The author thus hypothesised that inclusion of TLC-NOSF dressing in dressing regimes would enhance wound healing and improve outcomes in CCW. This paper successfully verifies the hypothesis on three such
wounds, with good wound healing outcomes achieved.
Diabetic Foot Ulcer Management with TLC-NOSF (Technology Lipido-Colloid Nano-Oligosaccharide Factor) Wound Dressings from China
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
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.
