Advice

Technology overview

Technology overview

This briefing describes the regulated use of the technology for the indication specified, in the setting described, and with any other specific equipment referred to. It is the responsibility of healthcare professionals to check the regulatory status of any intended use of the technology in other indications and settings.

About the technology

CE marking

CircAid Medical Products was awarded a CE‑mark for the Juxta CURES in September 2012 as a class I medical device. Under this CE‑mark the Juxta CURES is described by the Universal Medical Device Nomenclature System (UMDNS) as 'bandages compression support'. The Juxta CURES device, liners and compression anklets are included within the certification. CircAid Medical Products was acquired in 2012 by medi UK, which currently holds the CE certification for the device.

Description

The Juxta CURES is an adjustable, wrap-around compression system made of breathable inelastic fabric. It is designed to be applied over conventional wound dressings, for the treatment of VLUs as an alternative to compression bandaging. The Juxta CURES pack includes:

  • 1 Juxta CURES device (body and spine)

  • 2 comfort leg liners

  • 2 comfort compression anklets

  • 1 built-in pressure system (BPS) card

  • 1 disposable paper measuring tape

  • 6 Velcro stays

  • 2 sets of instructions for use (1 for the clinician and 1 for the patient).

An instructional video is available online the MediUK website.

The leg liner is fitted over the leg and any dressings on the VLU. The Juxta CURES device is made up of 2 fabric pieces: a 'body' and a 'spine'. The body is a large piece of fabric that wraps around the lower leg; it has measurements marked along the top and bottom edges showing different ankle and calf circumference measurements. The spine of the device is fitted to the body by lining it up with the correct ankle and calf measurements for each patient, allowing the Juxta CURES to be adapted to fit a wide range of leg sizes. The spine attaches to the body using Velcro, and additional separate Velcro stays can be used to improve adhesion. Once the spine is in the correct position, excess fabric from the body can be cut off.

Once the Juxta CURES has been initially adjusted to fit the patient it should be put on over the leg liner. The Juxta CURES should be loosely secured using the 4 attached Velcro-lined straps to ensure it is in the correct position before adjusting it to the correct pressure using the BPS card.

The pressure applied by the Juxta CURES is managed via 3 Velcro straps that can be tightened or loosed to achieve the pressure prescribed by the clinician. The pressure is determined using the 5‑sided BPS card, each side of which has markings corresponding to a different range of ankle circumferences. For each range, marks on the card correspond to different pressure levels. These marks are aligned to parallel lines on the Velcro straps to measure and apply the prescribed pressure, of either 20, 30, 40 or 50 mmHg. The 3 Velcro straps are each tightened (or loosened) to align the appropriate marks on the BPS card with the parallel lines on each strap and achieve the correct pressure. The BPS card can be used by the patient at home to ensure that the correct pressure is achieved whenever the Juxta CURES is applied, and throughout the day, to allow for any reduction in swelling or for improved comfort.

The comfort compression anklet is applied after the Juxta CURES has been fitted. It applies light pressure to the foot and ankle, to prevent and control oedema. Two anklets can be applied together if additional compression is needed.

The Juxta CURES is available in 3 lengths: short (28 cm), standard (33 cm) and long (38 cm) and will fit patients with an ankle circumference of up to 42 cm and maximum calf circumference of 64 cm. The length of the Juxta CURES is chosen depending on the patient's ankle to knee crease measurement. The comfort compression anklet is available in 2 sizes: standard and large. The Juxta CURES is guaranteed for 6 months, is machine washable and can be tumble dried on a cool setting. The comfort compression anklet is not covered by the warranty and will not be replaced unless defective.

It is important that all Velcro straps are securely applied to prevent the risk of falls. This is particularly important when patients are wearing Juxta CURES on both legs.

Intended use

The Juxta CURES is a compression device intended to be used over primary dressings for the treatment of open VLUs. The manufacturer's indications for use are: venous insufficiency, venous stasis ulcers, post‑thrombotic syndrome and dependent oedema.

The manufacturer states that the Juxta CURES should not be used for people with the following conditions:

  • severe peripheral arterial disease

  • decompensated congestive heart failure

  • septic phlebitis

  • phlegmasia cerulea dolens

  • decreased or absent sensation in the leg

  • allergy to compression materials

  • moderate peripheral arterial disease

  • infection in the leg.

Setting and intended user

After the initial fitting, the Juxta CURES can be used in any setting including in the community and at home, and it can be applied and adjusted by patients, carers or clinicians. The BPS guide card allows the user to maintain the prescribed pressure. Follow‑up appointments with a clinician are needed to allow for any subsequent adjustments to ensure that the Juxta CURES fits correctly. Adjustments may be needed because of reduced swelling in the leg. If the reduction is significant, the spine of the device can be readjusted by the clinician until the swelling settles.

The clinician and patient instruction leaflets give advice on applying the device and day‑to‑day use and maintenance. Patients can carry on their usual activities while wearing the Juxta CURES, and can remove and reapply it as needed to change dressings and bathe. It is safe to be used day and night, and if the patient has discomfort while lying down they can reduce the pressure. As it allows users to wear everyday shoes, the Juxta CURES is safe to use while driving. The ability to adjust the device as swelling reduces ensures that the correct pressure is maintained between clinician visits.

The Juxta CURES is can be prescribed on an FP10 prescription and may be fitted and adjusted by a trained clinician.

The Scottish Intercollegiate Guideline Network (SIGN) guideline on the management of chronic venous leg ulcers specifies that compression therapy should only be applied by staff with appropriate training. It also recommends that specialist leg ulcer clinics are the best place for community treatment of venous leg ulcers. Assessment by a clinician with suitable training and experience will still be needed to ensure compression therapy is appropriate and to decide the correct level of compression.

Current NHS options

The NICE clinical knowledge summary on venous leg ulcers advises uncomplicated ulcers should be treated by cleaning and dressing the ulcer, applying compression therapy and providing appropriate follow-up care and lifestyle advice. For patients with persistent VLUs, specialist referral should be considered and compression therapy choices and lifestyle advice should be reviewed with the patient.

This advice states that wounds should be cleaned with warm tap water or saline. Dressings should be simple (not, for example, alginate dressings, hydrocolloids, hydrogels or foams), have low adherence to prevent damage to the wound bed and be acceptable to the patient. Current national guidelines suggest that there is insufficient evidence to endorse the use of any specific type of dressing (Royal College of Nursing [RCN] 2006, SIGN 2010), therefore the dressings used should be low cost. For patients who do not need frequent bandage changes, the choice of dressings should be determined by their ability to stay in place for up to a week.

The RCN recommendations (2006) advise that the most important treatment for uncomplicated venous ulcers is the application of high compression using a stocking or bandage. It recommends that multi-layer bandaging with adequate padding should be applied at the highest-tolerated compression, and that the bandaging should be capable of maintaining compression for at least 1 week. In patients with an ankle brachial pressure index of less than 0.8 and in those with diabetes, compression should be used only under specialist advice and close monitoring. Compression should be applied only by trained staff.

The following standards have been suggested for compression: mild (less than 20 mmHg), moderate (20–40 mmHg or less), strong (40–60 mmHg or more) and very strong (more than 60 mmHg). Pressures of 40 mmHg or more are generally recommended for the treatment of VLUs, although this may not be appropriate for some patients due to factors including arterial insufficiency, neuropathy or cardiac failure (Partsch 2008).

SIGN's guideline on the management of chronic VLUs advises that the following should be taken into account when considering which type of compression to use for VLUs:

  • practitioner level of expertise

  • frequency of application needed – this can be determined by several factors including levels of exudate, bandage slippage and swelling in the leg

  • leg size and shape

  • patient preference, lifestyle and likely concordance.

NICE is not aware of other devices available in the NHS that have a similar function to the Juxta CURES.

Costs and use of the technology

The Juxta CURES is listed on the NHS Drug Tariff, February 2015 at a cost of £151.50 per pack (excluding VAT). Additional comfort leg liners are available at a cost of £13.19 for 2 and comfort compression anklets are available at a cost of £11.16 for 2.

Juxta CURES can also be purchased directly from the manufacturer at a cost of £181.80 including VAT.

The NICE clinical knowledge summary on venous leg ulcers advises that, for people who are immobile, 4‑layer or 3‑layer bandaging is more suitable, whereas in those who are mobile, 2‑layer bandaging is more suitable. The Juxta CURES can be used for both mobile and immobile patients.

Illustrative examples of prices for conventional compression bandages and wadding, of which numerous alternatives are available, taken from the British National Formulary (December 2014), are listed below.

Sub-compression wadding bandage:

  • Padding: 3.5 m unstretched 10 cm, £0.47 Flexi-Ban (Activa).

  • Padding: 10 cm×3.5 cm unstretched, £0.37 Ortho-Band Plus (Steraid).

Multi-layer compression bandages, 2‑layer systems:

  • Multi-layer compression bandaging kit: 2‑layer system (latex‑free, foam bandage and cohesive compression bandage) 1 size, £8.08; Coban2 Lite (reduced compression) 1 size, £8.08. Coban2 (3M).

  • Multi-layer compression bandaging kit: 2‑layer system, size 0 (short), £6.55; 18–25 cm ankle circumference 8 cm, £7.32; 10 cm, £7.76; 12 cm, £9.78; 25–32 cm ankle circumference 8 cm, £7.96; 10 cm, £8.48; 12 cm, £10.69. K-Two (Urgo).

Multi-layer compression bandaging, 4‑layer systems:

  • Multi-layer compression bandaging kit: 4‑layer system for ankle circumference up to 18 cm, £6.73; 18–25 cm, £6.44; 25–30 cm, £6.44; above 30 cm, £8.87; reduced compression 18 cm and above, £4.21. K‑Four (Urgo).

  • Multi-layer compression bandaging kit: 4‑layer system for ankle circumference 18–25 cm, £7.46. System 4 (Mölnlycke).

  • Using the Juxta CURES will also incur additional cost as a trained clinician needs to assess the patient to ensure that compression therapy is appropriate before the system is initially used.

Likely place in therapy

It could be offered to most patients with VLUs, and may be particularly useful for patients who are unable or not willing to use traditional compression techniques. As it can be applied without specialist training it is suitable for GP prescribing, although a trained clinician will still need to assess the patient to ensure that compression therapy is appropriate.

Specialist commentator comments

One specialist commentator noted that, although the outcomes from the studies of the Juxta CURES were favourable, the numbers of patients involved in these studies made the data unreliable. They added that, in the context of the overall number of patients with venous leg ulcers, larger trials are warranted. This commentator felt that, although there is currently a lack of conclusive evidence, the Juxta CURES shows potential for both patients and clinicians in view of the recognised challenges of applying traditional compression bandages.

One specialist commentator reflected that the Juxta CURES could easily fit into the current patient pathway. Another commentator noted that current research suggests consistent delivery of correct care is an important factor to promote healing of VLUs. They commented that compression bandages are often applied at a lower pressure than advised, and that this results in reduced healing rates. Use of the BPS ensures compression is applied at the correct level.

The same commentator remarked that the Juxta CURES may help to ensure that compression therapy starts sooner and is applied at the correct pressure, as patients don't have to wait for a leg ulcer clinic appointment and more nurses could be trained to use the Juxta CURES. As less nursing time is needed to apply the Juxta CURES compared to standard compression therapy, this may increase the capacity of GP surgeries to provide compression therapy.

Three specialist commentators noted the benefit to patients (or carers) of being able to apply their own compression therapy and felt that there was potential for reduced clinician input. One felt that this could lead to significant cost savings and another noted this was safer than patients applying their own standard compression bandaging systems. There may also be a benefit in involving patients in their own care, with a positive impact on compliance and clinical outcomes.

Two specialist commentators noted the differences in costs and cost savings between the published studies and felt it would not be possible to make an informed decision on the cost benefits based on the examples given. One commentator felt that GPs may be deterred from prescribing the device due to its relatively high initial cost compared to other compression systems.

Equality considerations

NICE is committed to promoting equality and eliminating unlawful discrimination. We aim to comply fully with all legal obligations to:

  • promote race and disability equality and equality of opportunity between men and women

  • eliminate unlawful discrimination on grounds of race, disability, age, sex, gender reassignment, pregnancy and maternity (including women post‑delivery), sexual orientation, and religion or belief, in the way we produce our guidance (these are protected characteristics under the Equality Act 2010).

Age and disability are protected characteristics under the Equality Act 2010. Factors that increase the risk of developing venous leg ulcers include reduced mobility; previous deep vein thrombosis; injury or surgery to the leg; obesity and increased age. Appropriate treatment of venous leg ulcers may reduce healing times, control associated symptoms and improve quality of life for those affected.