References

Lazaro JL, Izzo V, Meaume S Elevated levels of matrix metalloproteinases and chronic wound healing: an updated review of clinical evidence. J Wound Care. 2016; 25:(5)277-287 https://doi.org/10.12968/jowc.2016.25.5.277

Yanhan R, Guosheng G, Min Y, Driver VR Role of matrix metalloproteinases in chronic wound healing: diagnostic and therapeutic implications. Chin Med J (Engl). 2014; 127:(8)1572-1581 https://doi.org/10.3760/cma.j.issn.0366-6999.20131179

Bui UT, Edwards H, Finlayson K Identifying risk factors associated with infection in patients with chronic leg ulcers. Int Wound J. 2018; 15:(2)283-290 https://doi.org/10.1111/iwj.12867

Jia L, Parker CN, Parker TJ Incidence and risk factors for developing infection in patients presenting with uninfected diabetic foot ulcers. PLoS One. 2017; 12:(5) https://doi.org/10.1371/journal.pone.0177916

Hsu L, Li L, Poon LY Analysis of risk factors of infection in diabetic foot patients. Int Wound J. 2024; 21:(1) https://doi.org/10.1111/iwj.14411

Edmonds M, Manu C, Vas P The current burden of diabetic foot disease. J Clin Orthop Trauma. 2021; 17:88-93 https://doi.org/10.1016/j.jcot.2021.01.017

Armstrong DG, Tan TW, Boulton AJ, Bus SA Diabetic foot ulcers. JAMA. 2023; 330:(1)62-75 https://doi.org/10.1001/jama.2023.10578

McDermott K, Fang M, Boulton AJ Etiology, epidemiology, and disparities in the burden of diabetic foot ulcers. Diabetes Care. 2023; 46:(1)209-221 https://doi.org/10.2337/dci22-0043

Polikandrioti M, Vasilopoulos G, Koutelekos I Quality of life in diabetic foot ulcer: associated factors and the impact of anxiety/depression and adherence to self-care. Int J Low Extrem Wounds. 2020; 19:(2)165-179 https://doi.org/10.1177/1534734619900415

Vogt TN, Koller FJ, Dias Santos PN Quality of life assessment in chronic wound patients using the Wound-QoL and FLQA-Wk instruments. Invest Educ Enferm. 2020; 38:(3) https://doi.org/10.17533/udea.iee.v38n3e11

Reinboldt-Jockenhöfer F, Babadagi Z, Hoppe HD Association of wound genesis on varying aspects of health-related quality of life in patients with different types of chronic wounds: results of a cross-sectional multicentre study. Int Wound J. 2021; 18:(4)432-439 https://doi.org/10.1111/iwj.13543

Chan KS, Lo ZJ, Wang Z A prospective study on the wound healing and quality of life outcomes of patients with venous leg ulcers in Singapore—interim analysis at 6 month follow up. Int Wound J. 2023; 20:(7)2608-2617 https://doi.org/10.1111/iwj.14132

Olsson M, Järbrink K, Divakar U The humanistic and economic burden of chronic wounds: a systematic review. Wound Repair Regen. 2019; 27:(1)114-125 https://doi.org/10.1111/wrr.12683

Guest JF, Fuller GW, Vowden P, Vowden KR Cohort study evaluating pressure ulcer management in clinical practice in the UK following initial presentation in the community: costs and outcomes. BMJ Open. 2018; 8:(7) https://doi.org/10.1136/bmjopen-2018-021769

International Diabetes Federation. IDF Diabetes Atlas. 2021. https://diabetesatlas.org/resources/ (accessed 10 September 2024)

Lower leg ulcer diagnosis and principles of treatment. 2023. https://tinyurl.com/mvfanen7 (accessed 10 September 2024)

Meloni M, Lazaro-Martínez JL, Ahluwalia R Effectiveness of fast-track pathway for diabetic foot ulcerations. Acta Diabetol. 2021; 58:(10)1351-1358 https://doi.org/10.1007/s00592-021-01721-x

Schaper NC, van Netten JJ, Apelqvist J Practical guidelines on the prevention and management of diabetes-related foot disease (IWGDF 2023 update). Diabetes Metab Res Rev. 2024; 40:(3) https://doi.org/10.1002/dmrr.3657

White R, Cowan T, Glover D Supporting evidence-based practice: a clinical review of TLC healing matrix, 2nd edition. : MA Healthcare Ltd; 2015

Nair H, Venkateshwaran N, Seetharaman SS Benefits of sucrose octasulfate (TLC-NOSF) dressings in the treatment of chronic wounds: a systematic review. J Wound Care. 2021; 30:S42-S52 https://doi.org/10.12968/jowc.2021.30.Sup4.S42

Lázaro-Martínez JL, García-Madrid M, García-Alamino JM Increasing transcutaneous oxygen pressure in patients with neuroischemic diabetic foot ulcers treated with a sucrose octasulfate dressing: a pilot study. Int J Low Extrem Wounds. 2022; 21:(4)450-456 https://doi.org/10.1177/1534734620952244

Lázaro-Martínez JL, García-Madrid M, Bohbot S Microcirculation improvement in diabetic foot patients after treatment with sucrose octasulfate-impregnated dressings. J Clin Med. 2023; 12:(3) https://doi.org/10.3390/jcm12031040

Edmonds M, Lázaro-Martínez JL, Alfayate-García JM Sucrose octasulfate dressing versus control dressing in patients with neuroischaemic diabetic foot ulcers (Explorer): an international, multicentre, double-blind, randomised, controlled trial. Lancet Diabetes Endocrinol. 2018; 6:(3)186-196 https://doi.org/10.1016/S2213-8587(17)30438-2

Meaume S, Dompmartin A, Lok C Quality of life in patients with leg ulcers: results from CHALLENGE, a double-blind randomised controlled trial. J Wound Care. 2017; 26:(7)368-379 https://doi.org/10.12968/jowc.2017.26.7.368

Schmutz JL, Meaume S, Fays S Evaluation of the nano-oligosaccharide factor lipido-colloid matrix in the local management of venous leg ulcers: results of a randomised, controlled trial. Int Wound J. 2008; 5:(2)172-182 https://doi.org/10.1111/j.1742-481X.2008.00453.x

Münter KC, Meaume S, Augustin M The reality of routine practice: a pooled data analysis on chronic wounds treated with TLC-NOSF wound dressings. J Wound Care. 2017; 26:S4-S15 https://doi.org/10.12968/jowc.2017.26.Sup2.S4

Dissemond J, Lützkendorf S, Dietlein M Clinical evaluation of polyabsorbent TLC-NOSF dressings on chronic wounds: a prospective, observational, multicentre study of 1140 patients. J Wound Care. 2020; 29:(6)350-361 https://doi.org/10.12968/jowc.2020.29.6.350

Augustin M, Keuthage W, Lobmann R Clinical evaluation of UrgoStart Plus dressings in real-life conditions: results of a prospective multicentre study on 961 patients. J Wound Care. 2021; 30:(12)966-978 https://doi.org/10.12968/jowc.2021.30.12.966

Meaume S, Senet P, Thomé B Impact of primary dressings on healing of venous leg ulcers: a French cohort study from the healthcare insurance database. J Wound Care. 2024; 33:(9)678-686 https://doi.org/10.12968/jowc.2024.0189

National Institute for Health and Care Excellence. UrgoStart for treating diabetic foot ulcers and leg ulcers. 2023. https://www.nice.org.uk/guidance/MTG42 (accessed 10 September 2024)

Wen J, Jin X, Al Sayah F Economic evaluation of sucrose octasulfate dressing for the treatment of diabetic foot ulcers for type 2 diabetes patients. Can J Diabetes. 2021; 46:126-133 https://doi.org/10.1016/j.jcjd.2021.07.001

Lobmann R, Augustin M, Lawall H Cost-effectiveness of TLC-sucrose octasulfate versus control dressings in the treatment of diabetic foot ulcers. J Wound Care. 2019; 28:(12)808-816 https://doi.org/10.12968/jowc.2019.28.12.808

Lobmann R, Grünerbel A, Lawall H Impact of wound duration on diabetic foot ulcer healing: evaluation of a new sucrose octasulfate wound dressing. J Wound Care. 2020; 29:(10)543-551 https://doi.org/10.12968/jowc.2020.29.10.543

Maunoury F, Oury A, Fortin S Cost-effectiveness of TLC-NOSF dressings versus neutral dressings for the treatment of diabetic foot ulcers in France. PLoS One. 2021; 16:(1) https://doi.org/10.1371/journal.pone.0245652

Chang L, Suang S, Libo T [Health economics evaluation of technology lipido-colloid with nano-oligo saccharide factor dressing versus non nano-oligo saccharide factor advanced wound care dressing in the treatment of diabetic foot ulcer]. Chin J Diabetes Mellitus. 2021; 13:(12) https://doi.org/10.3760/cma.j.cn115791-20210318-00165

Jiménez Salcedo D, Villasante J, Deandres F, Fernández Morata J Cost-effectiveness and cost-utility analysis of a sucrose octasulfate dressing versus a neutral dressing in patients with neuroischemic diabetic ulcers – EP233. J Wound Manage. 2023; 24:(2)

Mlcoch T, Bartakova J, Chadimova K Cost-effectiveness analysis of sucrose octasulfate (UrgoStart) dressing in the treatment of diabetic foot and venous leg ulcers. Value Health. 2019; 22 https://doi.org/10.1016/j.jval.2019.09.1435

Arroyo Ana A, Alvarez Vázquez JC, Blasco García C [Cost-effectiveness of a TLC-NOSF polyurethane foam dressing]. Rev Enferm. 2012; 35:(11)27-32

Augustin M, Herberger K, Kroeger K Cost-effectiveness of treating vascular leg ulcers with URGOSTART and URGOCELL Contact. Int Wound J. 2016; 13:(1)82-87 https://doi.org/10.1111/iwj.12238

Vas P, Rayman G, Dhatariya K Effectiveness of interventions to enhance healing of chronic foot ulcers in diabetes: a systematic review. Diabetes Metab Res Rev. 2020; 36 https://doi.org/10.1002/dmrr.3284

Dissemond J, Augustin M, Dietlein M Efficacy of MMP-inhibiting wound dressings in the treatment of chronic wounds: a systematic review. J Wound Care. 2020; 29:(2)102-118 https://doi.org/10.12968/jowc.2020.29.2.102

Haute autorité de Santé. [National Commission for the Evaluation of Medical Devices and Health Technologies]. 2023. https://tinyurl.com/e9khdync (accessed 18 September 2024)

Rayman G, Vas P, Dhatariya K Guidelines on use of interventions to enhance healing of chronic foot ulcers in diabetes (IWGDF 2019 update). Diabetes Metab Res Rev. 2020; 36 https://doi.org/10.1002/dmrr.3283

Chen P, Campillo Vilorio N, Dhatariya K Guidelines on interventions to enhance healing of foot ulcers in people with diabetes. IWGDF 2023 update. Diabetes Metab Res Rev. 2024; 40:(3) https://doi.org/10.1002/dmrr.3644

Araszkiewicz A, Bandurska-Stankiewicz E, Borys S Standards of care in diabetes. The position of Diabetes Poland – 2024. Current Topics in Diabetes. 2023; 3:(3–4)1-348 https://doi.org/10.5114/ctd/183052

Vietnamese Ministry of Health. [Decision 1530/QD-BYT 2023 Guidelines for the diagnosis and treatment of diabetic foot ulcers]. https://tinyurl.com/2enjuxkf (accessed 10 September 2024)

Lázaro Martínez JL, Almaraz MC, Álvarez Hermida Á Consensus document on actions to prevent and to improve the management of diabetic foot in Spain. Endocrinol Diabetes Nutr (Engl Ed). 2021; 68:(7)509-513 https://doi.org/10.1016/j.endien.2020.08.016

Chen P, Carville K, Swanson T 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. J Foot Ankle Res. 2022; 15:(1) https://doi.org/10.1186/s13047-022-00544-5

Boulton AJM, Armstrong DG, Löndahl M. New evidence-based therapies for complex diabetic foot wounds.: American Diabetes Association; 2022 https://doi.org/10.2337/db2022-02

Araszkiewicz A, Bandurska-Stankiewicz E, Borys S 2020 Guidelines on the management of diabetic patients. A position of Diabetes Poland. Clin Diabetol. 2021; 10 https://doi.org/10.5603/DK.2021.0001

Dissemond J, Augustin M, Dietlein M [Sucrose octasulfate—evidence in the treatment of chronic wounds]. Hautarzt. 2020; 71:(10)791-801 https://doi.org/10.1007/s00105-020-04637-9

Deutsche Gesellschaft für Wundheilung und Wundbehandlung e. V. [Local therapy of hard-to-heal and/or chronic wounds due to peripheral arterial occlusive disease, diabetes mellitus or chronic venous insufficiency]. 2023. https://tinyurl.com/tkcr93an (accessed 18 September 2024)

Sultan A, Bihan H, Bouillet B [2024 SFD diabetic foot guidelines]. Med Mal Metab. 2024; 18:174-197 https://doi.org/10.1016/j.mmm.2024.01.014

Meloni M, Bouillet B, Ahluwalia R Fast-track pathway for diabetic foot ulceration during COVID-19 crisis: a document from International Diabetic Foot Care Group and D-Foot International. Diabetes Metab Res Rev. 2021; 37:(3) https://doi.org/10.1002/dmrr.3396

UrgoStart Plus in real life. 2020. https://tinyurl.com/525ffhzb (accessed 10 September 2024)

[Guideline for the treatment of chronic wounds with polyabsorbent TLC-sucrose octasulfate wound dressings]. 2021. https://tinyurl.com/bdhc54s3

Di Venanzio M, Meloni M, Aleandri AR Effectiveness of the fast-track pathway for the management of patients with diabetic foot through the network between second and third level centers. J Adv Health Care. 2022; 4:(2)85-90 https://doi.org/10.36017/JAHC2204-11

Wu S, Duan R, Liang G [Rapid referral pathway for diabetic foot]. Chin J Diabetes Mellitus. 2022; 14:(6)633-637 https://doi.org/10.3760/cma.j.cn115791-20220423-00178

Best practice statement: Care of the person with diabetes and lower limb ulcers. 2021. https://tinyurl.com/yewbyyr2 (accessed 10 September 2024)

Liberati A, Altman DG, Tetzlaff J The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. PLoS Med. 2009; 6:(7) https://doi.org/10.1371/journal.pmed.1000100

Jeffcoate WJ, Bus SA, Game FL Reporting standards of studies and papers on the prevention and management of foot ulcers in diabetes: required details and markers of good quality. Lancet Diabetes Endocrinol. 2016; 4:(9)781-788 https://doi.org/10.1016/S2213-8587(16)30012-2

Gomersall JS, Jadotte YT, Xue Y Conducting systematic reviews of economic evaluations. Int J Evid-Based Healthc. 2015; 13:(3)170-178 https://doi.org/10.1097/XEB.0000000000000063

Institute of Health Economics (IHE). Case series studies quality appraisal checklist. 2024. https://tinyurl.com/2crn5b7w (accessed 10 September 2024)

Lázaro-Martínez JL, Edmonds M, Rayman G Optimal wound closure of diabetic foot ulcers with early initiation of TLC-NOSF treatment: post-hoc analysis of Explorer. J Wound Care. 2019; 28:(6)358-367 https://doi.org/10.12968/jowc.2019.28.6.358

Mullings J, Merlin-Manton E Improving patient outcomes through the implementation of a person-centred leg ulcer pathway. J Wound Care. 2018; 27:(6)378-384 https://doi.org/10.12968/jowc.2018.27.6.378

Milne J, Nichols J Optimising resources: an evidence-based pathway using UrgoStart for community-based patients with wounds. Br J Community Nurs. 2021; 26:(3)130-135 https://doi.org/10.12968/bjcn.2021.26.3.130

Meloni M, Giurato L, Panunzi A Effectiveness of sucrose octasulfate dressing in the treatment of neuro-ischaemic diabetic foot heel ulcers: a retrospective single arm study. Int J Low Extrem Wounds. 2022; https://doi.org/10.1177/15347346221087499

Reducing variation in care: Implementation of a leg ulcer pathway including treatment with UrgoStart Plus and UrgoKTwo compression system. 2020. https://tinyurl.com/mr35nxtx

NICE guidance in real life: Implementation of an evidence-based care pathway within a new wound healing clinic. 2021. https://tinyurl.com/zcsr3shh (accessed 10 September 2024)

Service evaluation: the benefits of TLC-NOSF dressings on patients with diabetic foot ulcers. 2022. https://tinyurl.com/ysnnxyp8 (accessed 10 September 2024)

Raffetto JD, Ligi D, Maniscalco R Why venous leg ulcers have difficulty healing: overview on pathophysiology, clinical consequences, and treatment. J Clin Med. 2020; 10:(1) https://doi.org/10.3390/jcm10010029

NHS England. National Diabetes Foot Care Audit Report – 2014–2016. 2017. https://tinyurl.com/bddrkdp2 (accessed 10 September 2024)

Smith-Strøm H, Iversen MM, Igland J Severity and duration of diabetic foot ulcer (DFU) before seeking care as predictors of healing time: a retrospective cohort study. PLoS One. 2017; 12:(5) https://doi.org/10.1371/journal.pone.0177176

The National Diabetes Foot Care Audit of England and Wales: achievements and challenges. 2020. https://tinyurl.com/mrx7sezu (accessed 10 September 2024)

Optimising care for patients with diabetic foot ulcers: overcoming the barriers. 2020. https://tinyurl.com/32jycnem (accessed 10 September 2024)

Richard JL, Martini J, Faraill MM Management of diabetic foot ulcers with a TLC-NOSF wound dressing. J Wound Care. 2012; 21:(3)142-147 https://doi.org/10.12968/jowc.2012.21.3.142

Sigal ML, Addala A, Maillard H Evaluation of TLC-NOSF dressing with poly-absorbent fibres in exuding leg ulcers: two multicentric, single-arm, prospective, open-label clinical trials. J Wound Care. 2019; 28:(3)164-175 https://doi.org/10.12968/jowc.2019.28.3.164

Conde-Montero E, Bohbot S, Grado Sanz R Association of autologous punch grafting, TLC-NOSF dressing and multitype compression therapy to rapidly achieve wound closure in hard-to-heal venous leg ulcers. J Med Vasc. 2020; 45:(6)316-325 https://doi.org/10.1016/j.jdmv.2020.10.123

Chitambira F Patient perspectives: explaining low rates of compliance to compression therapy. Wound Practice and Research. 2019; 27:(4)168-174 https://doi.org/10.33235/wpr.27.4.168-174

[Non-observance of medical compression in venous ulcers treatment]. 2017. https://tinyurl.com/pzb4vh2c (accessed 10 September 2024)

TLC-NOSF dressings as a first-line local treatment of chronic wounds: a systematic review of clinical evidence

02 December 2024
Volume 8 · Issue 3

Abstract

Objective:

Several national and international guidelines recommend lipidocolloid technology with a nano-oligosaccharide factor (TLC-NOSF) dressings (UrgoStart dressing range, Laboratoires Urgo, France) for treating patients with chronic wounds. However, these dressings are still often reported as second-line options, potentially leading to loss of opportunity for patients and additional costs for payers. This review aimed to explore the reported wound healing and patient outcomes as well as the related costs when the dressings were used as first-line treatment in patients with different types of chronic wounds.

Method:

A systematic review of the literature was conducted. Databases (MEDLINE, Embase, Emcare, and Google Scholar) were searched up to 1 February 2024, without any language or time period limitations. Studies were eligible if the evaluated dressings had been used as a first-line treatment for chronic wounds, that is, as an integral part of the standard of care (SoC) at the patient's first presentation and/or in recent wounds. The main evaluation criteria included: wound healing rate; time to reach wound closure; change in patients' quality of life (QoL); and associated costs. The quality of evidence of the included studies was appraised using well-recognised risk-of-bias tools suitable for different study designs. A narrative synthesis describes the findings in three sections depending on the type of comparison. This report followed the principles of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Results:

A total of 17 studies published between 2017 and 2024 met the eligibility criteria. A comparative analysis between TLC-NOSF dressings and standard dressings, both of which were used as first-line treatment, was reported in nine studies. A comparative analysis between the use of TLC-NOSF dressings as first-line and second-line treatments was reported in eight studies, and five studies reported a systematic use of the TLC-NOSF dressing as first-line treatment without a control group. Overall, the included studies had a relatively low risk of bias for the respective types of evidence. Data of 10,191 patients of both sexes and different age groups with a total of 10,203 wounds (diabetic foot ulcers, leg ulcers, pressure injuries, and other types of chronic wounds) were included in the analysis: 7775 treated with the evaluated dressing and 2428 treated with a comparator dressing. The data suggested that using TLC-NOSF as a first-line treatment for chronic wounds consistently resulted in significantly higher healing rates, shorter healing times, and cost savings compared with standard dressings used under similar conditions. Real-life evidence confirmed the results obtained in clinical trials and economic models, within similar ranges, regardless of the settings involved or of the characteristics of the patients and wounds treated. The wound healing rates ranged around 70–80% by week 20/24 and time-to-heal was reported on average around seven weeks, with slightly longer times reported in wounds with a more severe prognosis. Furthermore, the dressings were shown to improve patient QoL, and were well tolerated and accepted, supporting a wider adoption approach.

Conclusion:

The results of this review are aligned with the current guidelines recommending the use of TLC-NOSF dressings in the treatment of patients with chronic wounds. They support its wider implementation as a first-line treatment and as an integral part of SoC for these wounds in the daily practice of all centres involved in their management.

Chronic wounds, such as diabetic foot ulcers (DFUs), leg ulcers (LUs) or pressure injuries/ulcers (PI/Us), are characterised, from their onset, by a compromised wound healing process, with an excess of matrix metalloproteinases (MMPs), and impaired vascular network. This results in poor tissue oxygenation, prolonged inflammatory stages, deterioration of the wound bed tissue and delayed wound healing.1,2 These wounds also present a high risk of local infection and other serious, potentially life-threatening, complications requiring hospitalisation (e.g., local ischaemia)3,4,5,6,7,8 and are often associated with significant pain, reduced mobility and diminished quality of life (QoL) for patients.9,10,11,12,13 Their management has been shown to entail considerable costs for healthcare systems, representing at least 1–6% of total healthcare expenditure in developed countries.13,14 Furthermore, these costs are unlikely to decrease in the foreseeable future due to ageing populations and earlier development of chronic conditions, such as diabetes.15

Register now to continue reading

Thank you for visiting Wound Central and reading some of our peer-reviewed resources for wound care professionals. To read more, please register today. You’ll enjoy the following great benefits:

What's included

  • Access to clinical or professional articles

  • New content and clinical updates each month