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Venous Ulcers - Overview

Venous Ulcers - Overview

Venous Ulcers - Overview

INTRODUCTION 

Background

Venous leg ulcer (VLU) can be defined as an open skin lesion of the leg or foot that occurs in an area affected by venous hypertension.[1] (See Figure 1)

Guidelines, Quality Measures and resources for VLU prevention, assessment and management are listed below. For and introduction and assessment of venous leg ulcers (VLU) including epidemiology, risk factors, etiology, pathophysiology, history, physical examination, diagnosis, differential diagnoses, documentation and ICD-10 coding, see "Venous Ulcers - Introduction and Assessment". For VLU management including a section for clinicians on patient education, see "Venous ulcers - Treatment and Prevention".


Figure 1. Highly exudative venous ulcer

Relevance 

  • Approximately 1% of the population in the United States, 3% of people over 80 years of age in westernized countries.[2] Prevalence is increasing, coinciding with an aging population. In the U.S., VLUs affect between 500,000 to 2 million people per year [3].
  • VLUs can result in pain, unpleasant odor, reduced mobility, sleep disturbance, reduced psychological well-being and social isolation.[4] In severe cases and when associated with arterial insufficiency, VLUs can lead to limb amputation. [5][6]
  • Despite the relatively low prevalence, VLUs represent a significant financial burden to the healthcare system in the U.S., estimated to be between US$ 2 and 2.5 billion per year. [1][7] One study estimated the overall burden to Medicare and private insurers due to VLU in the U.S. (excluding out-of-pocket payments and other indirect costs such as lost productivity) to be of US$14.9 billion (in 2012 US$ ). [8] In the U.K., estimated costs to treat a person with open leg ulcer is around GBP 1700 (US$ 2122) per year at 2012 prices, mostly related to nursing time. [9]

EVIDENCE-BASED CLINICAL GUIDELINES

Below is a list of the some of the most recent evidence-based guidelines on VLU: 

Evidence-based guideline, Year Publishing Organization, Country or Region Links
Compression therapy after invasive treatment of superficial veins of the lower extremities: Clinical practice guidelines of the American Venous Forum, Society for Vascular Surgery, American College of Phlebology, Society for Vascular Medicine, and International Union of Phlebology, 2019 [10]
American Venous Forum, Society for Vascular Surgery, American College of Phlebology, Society for Vascular Medicine, and International Union of Phlebology
Guideline (free)
The wound/burn guidelines – 5: Guidelines for the  management of lower leg ulcers/varicose veins, 2016 [11] 
Japanese Dermatological Association, Japan
Guideline (free)
Evidence‐based (S3) guidelines for diagnostics and treatment of venous leg ulcers, 2016 [12]
European Dermatology Forum, Europe
Guideline (free)
Wound healing society 2015 update on guidelines for venous ulcers, 2015 [13]
Wound Healing Society, USA
Guideline (free)
The International Consolidated Venous Ulcer Guideline Update, 2015 [14] 
Association for the Advancement of Wound Care (AAWC), Wound Healing Society, and the Canadian Association for Enterostomal Therapy formed the International Consolidated Guidelines Taskforce, North America
Guideline (free)
Management of Chronic Venous Disease, Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS), 2015 [15]  
European Society for Vascular Surgery (ESVS), Europe
Guideline (free)
Management of venous leg ulcers: Clinical practice guidelines of the Society for Vascular Surgery (SVS) and the American Venous Forum  (AVF), 2014 [1]
The Society for Vascular Surgery and American Venous  Forum, USA
Guideline (free)

QUALITY MEASURES

Setting CMS Program Developed by Measure ID Title Description/ benchmark (when available)
Outpatient Quality Payment Program - Merit-based incentive payment system (MIPS) (*) US Wound Registry CDR3 Process measure: Plan of Care Creation for Diabetic Foot Ulcer (DFU) and Venous Leg Ulcer (VLU) not Achieving 30% Closure at 4 Weeks
A plan of care needs to be created for patients that fail to achieve 30% of wound closure within 4 weeks of the application of the first CTP, and will include review of whether appropriate usual care has been implemented as well as whether further CTP applications are indicated
Outpatient Quality Payment Program - Merit-based incentive payment system (MIPS) (*)
US Wound Registry
CDR5 Process measure: Adequate Compression of Venous Leg Ulcers (VLU) at each treatment visit, appropriate to arterial supply. 
Percentage of venous leg ulcer visits among patients aged 18 years and older in which adequate compression is provided within the 12-month reporting period. Compression method should be appropriate to documented arterial supply. As a benchmark, among providers reporting this measure, performance is more than 70% of visits. However, among providers who do NOT report the measure, compression is provided in only 25% of VLU visits
Outpatient
Quality Payment Program - Merit-based incentive payment system (MIPS) (*)
US Wound Registry  CDR6

Venous Leg Ulcer outcome measure: Healing or Closure 

Percentage of venous leg ulcers among patients age 18 or older that have achieved healing or closure within 12 months, stratified by the Wound Healing Index (WHI). As a benchmark, performance rate in 2016 was 19% for WHI 1, 35% for WHI 2, and 54% for WHI 3
OutpatientQuality Payment Program - Merit-based incentive payment system (MIPS) (*)
US Wound Registry 
CDR9Appropriate use of Cellular and/or Tissue Based Product (CTP) in diabetic foot ulcers (DFUs) or venous leg ulcer (VLUs) among patients 18 years or older
Percent of patients 18 or older with venous or diabetic foot ulcer who receive cellular and/or tissue based products (CTPs) appropriately. Appropriate Use of CTPs for a DFU or VLU is defined as use that adheres to Medicare coverage policy regarding the total number of applications over a specific timeframe. Regional Medicare Administrative  Carrier (MAC) policies differ but using the most restrictive Local Coverage Determination (LCD),  appropriate use is defined as:  No more than 10 applications per wound, CTP applications do not continue if the wound is unchanged in size or larger in size after 4 weeks have elapsed from the first application, CTP applications do not continue once the wound is 0.5 cm2 or smaller. Prior to application of a CTP, patient should undergo vascular assessment to exclude ischemia, control bioburden, and debride necrotic material, as well as provide other appropriate basic interventions such as compression of a venous ulcer or offloading of a diabetic foot ulcerCurrently the benchmark rate is only 23%.
Outpatient
Quality Payment Program - Merit-based incentive payment system (MIPS) (*)
US Wound Registry 
USWR22
Patient Reported Measure: Patient Reported Nutritional Assessment in Patients with   Wounds and Ulcers

The percentage of patients aged 18 years and older with a diagnosis of a wound or ulcer of any type who self-report nutritional screening with a validated tool (such as the Self-MNA® by Nestlé) as well as food insecurity assessment, AND for whom the clinician provides and documents  a follow up/ intervention plan within the 12-month reporting period.


Outpatient
Quality Payment Program - Merit-based incentive payment system (MIPS) (*)
US Wound Registry 
USWR23
Non Invasive Arterial Assessment of patients with lower extremity wounds or ulcers for determination of healing potential
Percentage of patients aged 18 years or older with a non healing lower extremity wounds or ulcers that underwent a non-invasive arterial assessment once in a 12 month period, stratified by ABI, perfusion pressure, or oximetry
Outpatient
Quality Payment Program - Merit-based incentive payment system (MIPS) (*)
US Wound Registry
USWR24
Patient Reported Experience of Care: Wound Outcome
All eligible patients with wounds or ulcers who completed of Wound Outcome Questionnaire who showed 10% improvement at discharge or transfer to another site of care during the 12 month reporting period.
Outpatient
Quality Payment Program - Merit-based incentive payment system (MIPS) (*)
Medicare
MIPS 128
Preventative Care and Screening: Body Mass Index (BMI) Screening and Follow-Up

Percentage of patients aged 18 years and older with a BMI documented during the current encounter or during the previous twelve months AND with a BMI outside of normal parameters, a follow-up plan is documented during the encounter or during the previous twelve months of the current encounter


Outpatient
Quality Payment Program - Merit-based incentive payment system (MIPS) (*)
MedicareMIPS 131
Pain Assessment and Follow-Up
Percentage of visits for patients aged 18 years and older with documentation of a pain assessment using a standardized tool(s) on each visit AND documentation of a follow-up plan when pain is present

* The Quality Payment Program was implemented in the U.S. by Medicare in 2017. Merit-based incentive payment system (MIPS) is designed for eligible clinicians who bill under Medicare Part B. 


RESOURCES


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NOTE: This is a controlled document. This document is not a substitute for proper training, experience, and exercising of professional judgment. While every effort has been made to ensure the accuracy of the contents, neither the authors nor the Wound Reference, Inc. give any guarantee as to the accuracy of the information contained in them nor accept any liability, with respect to loss, damage, injury or expense arising from any such errors or omissions in the contents of the work.

REFERENCES

  1. O'Donnell, Thomas F; Passman, Marc A; Marston, William A; Ennis, William J; Dalsing, Michael; Kistner, Robert L; Lurie, Fedor; Henke, Peter K; Gloviczki, Monika L; Eklöf, Bo G; Stoughton, Ju... et al. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery ® and the American Venous Forum. Journal of Vascular Surgery. 2014;volume 60(2 Suppl):3S-59S.
  2. Franks, Peter J; Barker, Judith; Collier, Mark; Gethin, Georgina; Haesler, Emily; Jawien, Arkadiusz; Laeuchli, Severin; Mosti, Giovanni; Probst, Sebastian; Weller, Carolina et al. Management of patients with venous leg ulcers: challenges and current best practice. Journal of Wound Care. 2016;volume 25 Suppl 6():S1-S67.
  3. AHRQ, et al. Chronic Venous Ulcers: A Comparative Effectiveness Review of Treatment Modalities Comparative Effectiveness Review. 2017;.
  4. Westby, Maggie J; Norman, Gill; Dumville, Jo C; Stubbs, Nikki; Cullum, Nicky et al. Protease-modulating matrix treatments for healing venous leg ulcers. Cochrane Database of Systematic Reviews. 2016;volume 12():CD011918.
  5. Valencia, I C; Falabella, A; Kirsner, R S; Eaglstein, W H et al. Chronic venous insufficiency and venous leg ulceration. Journal of the American Academy of Dermatolog.... 2001;volume 44(3):401-21; quiz 422.
  6. Dumville, J C; Worthy, G; Soares, M O; Bland, J M; Cullum, N; Dowson, C; Iglesias, C; McCaughan, D; Mitchell, J L; Nelson, E A; Torgerson, D J; VenUS II team et al. VenUS II: a randomised controlled trial of larval therapy in the management of leg ulcers. Health Technology Assessment. 2009;volume 13(55):1-182, iii.
  7. . Diagnosis and Treatment of Venous Ulcers - American Family Physician . 2017;.
  8. Rice, J Bradford; Desai, Urvi; Cummings, Alice Kate G; Birnbaum, Howard G; Skornicki, Michelle; Parsons, Nathan et al. Burden of venous leg ulcers in the United States. Journal of medical economics. 2014;volume 17(5):347-356.
  9. Ashby, Rebecca L; Gabe, Rhian; Ali, Shehzad; Adderley, Una; Bland, J Martin; Cullum, Nicky A; Dumville, Jo C; Iglesias, Cynthia P; Kang'ombe, Arthur R; Soares, Marta O; Stubbs, Nikki C; Torg... et al. Clinical and cost-effectiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous leg Ulcer Study IV, VenUS IV): a randomised controlled trial. The Lancet. 2014;volume 383(9920):871-879.
  10. Lurie F, Lal BK, Antignani PL, Blebea J, Bush R, Caprini J, Davies A, Forrestal M, Jacobowitz G, Kalodiki E, Killewich L, Lohr J, Ma H, Mosti G, Partsch H, Rooke T, Wakefield T et al. Compression therapy after invasive treatment of superficial veins of the lower extremities: Clinical practice guidelines of the American Venous Forum, Society for Vascular Surgery, American College of Phlebology, Society for Vascular Medicine, and International Union of Phlebology. Journal of vascular surgery. Venous and lymphatic disorders. 2019;volume 7(1):17-28.
  11. Ito T, Kukino R, Takahara M, Tanioka M, Nakamura Y, Asano Y, Abe M, Ishii T, Isei T, Inoue Y, Imafuku S, Irisawa R, Ohtsuka M, Ohtsuka M, Ogawa F, Kadono T, Kawakami T, Kawaguchi M, Kono T, Kodera M, Sakai K, Nakanishi T, Hashimoto A, Hasegawa M, Hayashi M, Fujimoto M, Fujiwara H, Maekawa T, Matsuo K, Madokoro N, Yamasaki O, Yoshino Y, Le Pavoux A, Tachibana T, Ihn H, Wound/Burn Guidelines Committee. et al. The wound/burn guidelines - 5: Guidelines for the management of lower leg ulcers/varicose veins. The Journal of dermatology. 2016;volume 43(8):853-68.
  12. Neumann HA, Cornu-Thénard A, Jünger M, Mosti G, Munte K, Partsch H, Rabe E, Ramelet AA, Streit M et al. Evidence-based (S3) guidelines for diagnostics and treatment of venous leg ulcers. Journal of the European Academy of Dermatology and Venereology : JEADV. 2016;.
  13. Gould L, Stuntz M, Giovannelli M, Ahmad A, Aslam R, Mullen-Fortino M, Whitney JD, Calhoun J, Kirsner RS, Gordillo GM et al. Wound Healing Society 2015 update on guidelines for pressure ulcers. Wound repair and regeneration : official publication of the Wound Healing Society [and] the Eur.... 2016;volume 24(1):145-62.
  14. Couch KS, Corbett L, Gould L, Girolami S, Bolton L et al. The International Consolidated Venous Ulcer Guideline Update 2015: Process Improvement, Evidence Analysis, and Future Goals. Ostomy/wound management. 2017;volume 63(5):42-46.
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