Changes

March 2022 — reviewed. A literature search was conducted in March 2022 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials (RCTs) published since the last revision of the topic. 

Update

Goals

To support primary healthcare professionals to:

• Make an accurate diagnosis and assessment of a person with venous skin changes.
• Manage a person with venous skin changes.
• Provide appropriate information and advice to a person with venous skin changes.
• Appropriately refer to a specialist where necessary.

Outcome measures

Audit criteria

QOF indicators

QIPP - Options for local implementation

NICE quality standards

What is it?

• Venous eczema and lipodermatosclerosis are skin changes of the lower legs in people with chronic venous insufficiency.
  • Venous eczema (also known as varicose, gravitational, or stasis eczema) is an inflammatory condition characterized by red, itchy, scaly, or flaky skin, which may have blisters and crusts on the surface. 
  • Lipodermatosclerosis (which may be acute or chronic) results from chronic inflammation and fibrosis of the dermis and subcutaneous tissue of the lower legs. 

  [DermNet NZ, 2016; DermNet NZ, 2018; BAD, 2020; PCDS, 2021b]

What are the causes and risk factors?

• Venous skin changes occur in people with chronic venous insufficiency, caused by venous valve incompetence or an impaired calf muscle pump, which results in sustained venous hypertension.
  • In the normal venous system, venous pressure decreases with exercise as a result of the action of the calf muscle pump. When the calf muscles relax, the valves in the perforating veins (which connect the superficial veins to the deep veins) prevent reflux of blood and the pressure remains low.
  • If there is reflux of blood due to valve damage or calf muscle pump impairment, the venous pressure remains high, resulting in venous distension, oedema, and venous skin changes (hyperpigmentation, venous eczema, lipodermatosclerosis, and atrophie blanche). As the condition of the skin and subcutaneous tissue worsens, it becomes increasingly vulnerable to ulceration. See the CKS topic on Leg ulcer - venous for more information.
  • The cause of skin changes is unclear. One theory is that it is due to leakage of blood constituents into the surrounding tissues, with subsequent activation of inflammatory cells and fibroblasts.
• Risk factors include:
  • Advancing age. 
  • Trauma. 
  • Being overweight or obese.
  • Family history of venous insufficiency. 
  • Immobility. 
  • Chronic swelling of lower leg, aggravated by hot weather and prolonged standing.
  • Varicose veins.
  • Previous history of deep vein thrombosis, cellulitis, or venous leg ulcers.

[Grey, 2006; Barron, 2007; Middleton, 2007; Charles, 2013; Kelechi, 2015; DermNet NZ, 2016; Sundaresan, 2017; BAD, 2020; BMJ, 2020; PCDS, 2021a; PCDS, 2021c]

How common is it?

• Venous eczema is common, especially in elderly people.
  • It is reported to affect about 20% of people aged over 70 years. 
  • Around 10% of people with varicose veins go on to develop venous skin changes. See the CKS topic on Varicose veins for more information. 

[DermNet NZ, 2016; Nazarko, 2016]

What are the complications?

• Complications of venous skin changes include:
  • Chronic pain. 
  • Impetiginization or cellulitis. 
  • Secondary eczema (eczema spreads to other areas of the body).
  • Contact dermatitis (caused by allergens in topical treatments).
  • Permanent skin pigmentation. 
  • Poor wound healing. 
  • Skin ulceration. 
  • Negative impacts on quality of life and daily functioning.

[Barron, 2007; Charles, 2013; DermNet NZ, 2016; DermNet NZ, 2018; BAD, 2020]

What is the prognosis?

• Venous insufficiency cannot be cured and it is a progressive disease, however it is not limb threatening.
• Treatment can improve symptoms and slow progression, however associated conditions, such as venous eczema and lipodermatosclerosis are usually chronic and recurring. 
• Factors associated with a poorer prognosis include:
  • Ulceration. See the CKS topic on Leg ulcer - venous for more information.
  • Arterial insufficiency. See the CKS topic on Peripheral arterial disease for more information.

[DermNet NZ, 2016; DermNet NZ, 2018; BAD, 2020; BMJ, 2020]

How should I assess the person?

• Take a history. 
  • Ask about other symptoms of venous insufficiency, such as pain, heavy legs, leg fatigue, itching, swelling, aching, and/or discomfort of the affected leg. Symptoms are typically worse at the end of the day and are relieved by leg elevation. 
  • Identify risk factors for venous insufficiency, such as immobility and previous history of deep vein thrombosis (DVT).
• Examine the person. 
  • Assess and document the nature and severity of skin changes. Venous skin changes usually occur on the lower legs and are often bilateral, and can include: 
    • Hyperpigmentation (brown-red discolouration) results from haemosiderin deposition as red blood cells extravasate into the surrounding tissue. 
    • Venous eczema is characterized by red, itchy, scaly, or flaky skin, which may have blisters and crusts on the surface. Pain and swelling may also be present. 
    • Lipodermatosclerosis (which may be acute or chronic) results from chronic inflammation and fibrosis of the dermis and subcutaneous tissue of the lower legs. 
    • Acute lipodermatosclerosis (sclerosing panniculitis) is characterized by painful inflammation above the ankles, which may be mistaken for cellulitis or phlebitis. 
    • Chronic lipodermatosclerosis may follow an acute episode or develop gradually. It is characterized by painful, hardened, tight, red or brown skin, which if circumferentially affecting the ankle area may eventually result in the leg having an 'inverted champagne bottle' or 'bowling pin' appearance. 
    • Atrophie blanche — polyangular or star-shaped ivory white depressed atrophic plaques surrounded by red spots (small dilated capillaries) and sometimes hyperpigmentation. 
  • Examine the legs for other signs of venous insufficiency, including:
    • Varicose veins — examine the person standing and lying, and document the location and severity of any varicose veins. See the CKS topic on Varicose veins for more information.
    • Pitting oedema — this is usually unilateral, but can be bilateral. Initially occurs in the ankle region, but may extend to the leg and foot. Exclude non-venous causes of oedema, such as heart failure and chronic kidney disease. See the CKS topics on Heart failure - chronic and Chronic kidney disease for more information.
  • Assess for complications of venous skin changes, such as infection and leg ulceration. See the CKS topic on Leg ulcer - venous for more information.

Scenario: Management

From age 18 years onwards.

Search strategy

Scope of search

A literature search was conducted for guidelines, systematic reviews and randomized controlled trials on primary care management of venous eczema and lipodermatosclerosis.

Search dates

May 2017 - March 2022

Key search terms

Various combinations of searches were carried out. The terms listed below are the core search terms that were used for Medline.

• exp Varicose Veins/, varicose vein$.tw., exp Venous Insufficiency/
• exp Scleroderma, Localized/ or Scleroderma Systemic/, lipodermatosclerosis.tw., exp Varicose Ulcer/, venous ulcer.tw., venous eczema.tw., varicose eczema.tw., exp leg dermatoses/

Sources of guidelines

• National Institute for Health and Care Excellence (NICE)
• Scottish Intercollegiate Guidelines Network (SIGN)
• Royal College of Physicians
• Royal College of General Practitioners
• Royal College of Nursing
• NICE Evidence
• World Health Organization
• Guidelines International Network
• TRIP database
• Agency for Healthcare Research and Quality
• Institute for Clinical Systems Improvement
• National Health and Medical Research Council (Australia)
• Royal Australian College of General Practitioners
• British Columbia Medical Association
• Canadian Medical Association
• Alberta Medical Association
• Michigan Quality Improvement Consortium
• Singapore Ministry of Health
• National Resource for Infection Control
• RefHELP NHS Lothian Referral Guidelines
• Medline (with guideline filter)
• Driver and Vehicle Licensing Agency
• NHS Health at Work (occupational health practice)

Sources of systematic reviews and meta-analyses

• The Cochrane Library:
  • Systematic reviews
  • Protocols
  • Database of Abstracts of Reviews of Effects
• Medline (with systematic review filter)
• EMBASE (with systematic review filter)

Sources of health technology assessments and economic appraisals

• NIHR Health Technology Assessment programme
• The Cochrane Library:
  • NHS Economic Evaluations
  • Health Technology Assessments
• Canadian Agency for Drugs and Technologies in Health
• International Network of Agencies for Health Technology Assessment

Sources of randomized controlled trials

• The Cochrane Library:
  • Central Register of Controlled Trials
• Medline (with randomized controlled trial filter)
• EMBASE (with randomized controlled trial filter)

Sources of evidence based reviews and evidence summaries

• Bandolier
• Drug and Therapeutics Bulletin
• TRIP database
• Central Services Agency COMPASS Therapeutic Notes

Sources of national policy

• Department of Health
• Health Management Information Consortium (HMIC)

Patient experiences

• Healthtalk
• BMJ - Patient Journeys

Sources of medicines information

The following sources are used by CKS pharmacists and are not necessarily searched by CKS information specialists for all topics. Some of these resources are not freely available and require subscriptions to access content.

• British National Formulary (BNF)
• electronic Medicines Compendium (eMC)
• European Medicines Agency (EMEA)
• LactMed
• Medicines and Healthcare products Regulatory Agency (MHRA)
• REPROTOX
• Scottish Medicines Consortium
• Stockley's Drug Interactions
• TERIS
• TOXBASE
• Micromedex
• UK Medicines Information

Stakeholder engagement

Our policy

The external review process is an essential part of CKS topic development. Consultation with a wide range of stakeholders provides quality assurance of the topic in terms of:

• Clinical accuracy.
• Consistency with other providers of clinical knowledge for primary care.
• Accuracy of implementation of national guidance (in particular NICE guidelines).
• Usability.

Principles of the consultation process

• The process is inclusive and any individual may participate.
• To participate, an individual must declare whether they have any competing interests or not. If they do not declare whether or not they have competing interests, their comments will not be considered.
• Comments received after the deadline will be considered, but they may not be acted upon before the clinical topic is issued onto the website.
• Comments are accepted in any format that is convenient to the reviewer, although an electronic format is encouraged.
• External reviewers are not paid for commenting on the draft topics.
• Discussion with an individual or an organization about the CKS response to their comments is only undertaken in exceptional circumstances (at the discretion of the Clinical Editor or Editorial Steering Group).
• All reviewers are thanked and offered a letter acknowledging their contribution for the purposes of appraisal/revalidation.
• All reviewers are invited to be acknowledged on the website. All reviewers are given the opportunity to feedback about the external review process, enabling improvements to be made where appropriate.

Stakeholders

• Key stakeholders identified by the CKS team are invited to comment on draft CKS topics. Individuals and organizations can also register an interest to feedback on a specific topic, or topics in a particular clinical area, through the Getting involved section of the Clarity Informatics website.
• Stakeholders identified from the following groups are invited to review draft topics:
  • Experts in the topic area.
  • Professional organizations and societies (for example, Royal Colleges).
  • Patient organizations, Clarity has established close links with groups such as Age UK and the Alzheimer’s Society specifically for their input into new topic development, review of current topic content and advice on relevant areas of expert knowledge.
  • Guideline development groups where the topic is an implementation of a guideline.
  • The British National Formulary team.
  • The editorial team that develop MeReC Publications.
• Reviewers are provided with clear instructions about what to review, what comments are particularly helpful, how to submit comments, and declaring interests.

Patient engagement

Clarity Informatics has enlisted the support and involvement of patients and lay persons at all stages in the process of creating the content which include:

• Topic selection
• Scoping of topic
• Selection of clinical scenarios
• First draft internal review
• Second draft internal review
• External review
• Final draft and pre-publication

Our lay and patient involvement includes membership on the editorial steering group, contacting expert patient groups, organizations and individuals.

Evidence exclusion criteria

Our policy

Scoping a literature search, and reviewing the evidence for CKS is a methodical and systematic process that is carried out by the lead clinical author for each topic. Relevant evidence is gathered in order that the clinical author can make fully informed decisions and recommendations. It is important to note that some evidence may be excluded for a variety of reasons. These reasons may be applied across all CKS topics or may be specific to a given topic.

Studies identified during literature searches are reviewed to identify the most appropriate information to author a CKS topic, ensuring any recommendations are based on the best evidence. We use the principles of the GRADE and PICOT approaches to assess the quality of published research. We use the principles of AGREE II to assess the quality of published guidelines.

Standard exclusions for scoping literature:

• Animal studies
• Original research is not written in English

Possible exclusions for reviewed literature:

• Sample size too small or study underpowered
• Bias evident or promotional literature
• Population not relevant
• Intervention/treatment not relevant
• Outcomes not relevant
• Outcomes have no clear evidence of clinical effectiveness
• Setting not relevant
• Not relevant to UK
• Incorrect study type
• Review article
• Duplicate reference

Organizational, behavioural and financial barriers

Our policy

The CKS literature searches take into consideration the following concepts, which are discussed at the initial scoping of the topic.

• Feasibility
  • Studies are selected depending on whether the intervention under investigation is available in the NHS and can be practically and safely undertaken in primary care.
• Organizational and Financial Impact Analysis
• Studies are selected and evaluated on whether the intervention under investigations may have an impact on local clinical service provision or national impact on cost for the NHS. The principles of clinical budget impact analysis are adhered to, evaluated and recorded by the author. The following factors are considered when making this assessment and analysis.
  • Eligible population
  • Current interventions
  • Likely uptake of new intervention or recommendation
  • Cost of the current or new intervention mix
  • Impact on other costs
  • Condition-related costs
  • In-direct costs and service impacts
  • Time dependencies
• Cost-effectiveness or cost-benefit analysis studies are identified where available. 

We also evaluate and include evidence from NICE accredited sources which provide economic evaluations of recommendations, such as NICE guidelines. When a recommended action may not be possible because of resource constraints, this is explicitly indicated to healthcare professionals by the wording of the CKS recommendation.

Declarations of interest

Our policy

Clarity Informatics requests that all those involved in the writing and reviewing of topics, and those involved in the external review process to declare any competing interests. Signed copies are securely held by Clarity Informatics and are available on request with the permission of the individual. A copy of the declaration of interest form which participants are asked to complete annually is also available on request. A brief outline of the declarations of interest policy is described here and full details of the policy is available on the Clarity Informatics website. Declarations of interests of the authors are not routinely published, however competing interests of all those involved in the topic update or development are listed below. Competing interests include:

• Personal financial interests
• Personal family interest
• Personal non-financial interest
• Non-personal financial gain or benefit

Although particular attention is given to interests that could result in financial gains or losses for the individual, competing interests may also arise from academic competition or for political, personal, religious, and reputational reasons. An individual is not obliged to seek out knowledge of work done for, or on behalf of, the healthcare industry within the departments for which they are responsible if they would not normally expect to be informed.

Who should declare competing interests?

Any individual (or organization) involved in developing, reviewing, or commenting on clinical content, particularly the recommendations should declare competing interests. This includes the authoring team members, expert advisers, external reviewers of draft topics, individuals providing feedback on published topics, and Editorial Steering Group members. Declarations of interest are completed annually for authoring team and editorial steering group members, and are completed at the start of the topic update and development process for external stakeholders.

Competing interests declared for this topic:

None.