Evidence review

Clinical and technical evidence

Regulatory bodies

A search of the Medicines and Healthcare Products Regulatory Agency (MHRA) website revealed no manufacturer Field Safety Notices or Medical Device Alerts for this equipment.No reports of adverse events were identified from searches of the US Food and Drug Administration (FDA) database: Manufacturer and User Device Facility Experience (MAUDE).

Clinical evidence

Thirty one studies were identified for this briefing, however 21 were excluded as they did not meet the inclusion criteria, while 1 study was excluded as it did not contain any quantitative data. Therefore 9 studies have been included in this briefing. Four of these are published case studies of 1–3 patients (Bianchi et al. 2013; Dowsett and Elson 2013; Lawrence 2014a; Nugent et al.2013). Two publications also report cost savings (Bianchi et al. 2013; Nugent et al.2013). Four of the studies were only available as poster presentations; the case report by Davies (2013) and the 3 case series by Elson (2012), Harris (2013) and Oates et al. (2013). Of these, Elson et al. (2012) also reported cost savings. Finally, 1 case series was available as an abstract only (Lurie et al. 2012). The details and results of these studies are reported in tables 1–9.

One study by Harris (2013) reported that 3 of the 14 patients in this study decided to change to an alternative compression bandaging system. Their reasons were cited as preference, management of lymphoedema, and a fall. It is unclear if these events were device related.

Table 1 Summary of the Bianchi et al. (2013) case reports

Study component

Description

Objectives/hypotheses

To illustrate effective management using the Juxta CURES compression system.

Study design

Retrospective descriptive case reports on 3 patients.

Setting

Hospital, GP and community setting in the UK. Patients treated with the Juxta CURES 2012–13.

Inclusion/exclusion criteria

Venous disease of the lower limb.

Primary outcomes

Not applicable

Statistical methods

Not applicable

Participants

Case 1: a 42-year-old female with a 4-year history of leg ulcers. The patient was not compliant with compression therapy and preventative hosiery, resulting in frequent ulcer recurrence often resulting in hospitalisation due to cellulitis. The patient was clinically obese and had type 2 diabetes and epilepsy. Her job required her to stand for long periods with no facility to sit or elevate her leg. She had normal ABPI, with a wound measuring 7.5 cm × 5.5 cm completely covered in slough. She was reluctant to use compression bandages due to the negative impact on body image, inability to wear attractive shoes, uncontrolled exudate and bandage bulk and slippage.

Case 2: a 48-year-old male with a 12‑month history of non‑healing VLUs (size of wound not stated). This is likely to be the same patient as described by Nugent (2013; table 8).

Case 3: a 65-year-old female with recurrent leg ulcers since her late 40s. She had worsening, extremely painful, continuous non‑healing ulcers on both lower legs for the last 5 years. She had type 2 diabetes, hypertension and hyperthyroidism and needed a knee replacement. Allergy to cetearyl alcohol prevented use of numerous topical creams. Difficulties with compression therapy caused uncontrolled venous hypertension leading to lymphovenous disease.

Description

Case 1: The patient and practice nurses were trained in the use of the Juxta CURES.

Case 2: The Juxta CURES was applied at a pressure of 40 mmHg.

Case 3: The patient was admitted to hospital for 10 weeks of intensive wound management, including 4 weeks of intravenous antibiotics and multi‑layer lymphoedema bandaging. Ulcers were dressed with 7, 15 cm × 15 cm Aquacel dressings every other day, with 9 bandages applied at each dressing change. Oramorph was taken prior to dressing changes as analgesia, but she was comfortable between dressing changes and her legs improved rapidly. The Juxta CURES was prescribed to allow self-management on holidays while providing continued effective compression.

Results

Case 1: Clinic appointments were reduced from alternate days to twice weekly. After 3 weeks the wound reduced in size to 5 cm × 3.5 cm and after a further 3 weeks was 3.5 cm × 1.2 cm with the wound bed showing 50% slough and 50% granulation. A further few weeks showed the wound had almost closed. The patient and practice nurse found the device easy to use, and compliance was no longer an issue.

Case 2: The wound had decreased in size by 50% by the fifth week, and the wound area to the lateral and posterior aspects had healed. By week 10 there was further healing in wound size with 3 remaining wounds to the anterior aspect. The patient found the Juxta CURES very comfortable to wear and the ability to wear shoes was a bonus. The treatment regime also showed a significant cost saving.

Case 3: The patient reported that she had stopped taking painkillers and had an improved quality of life. She could bathe, shower and dress her own legs. The patient reported that the Juxta CURES felt light to wear, unlike bandages which used to weigh her legs down; she was also able to wear her own shoes. The Juxta CURES was reported to be easy to apply and took 30 minutes to apply, whereas conventional bandages had taken 1 hour.

Conclusions

Clinical experience using the Juxta CURES on less demanding ulcers has shown accelerated healing rates due to consistent compression. This is facilitated by a degree of self‑management from the patients.

Abbreviations: ABPI, ankle brachial pressure index; VLU, venous leg ulcer.

Table 2 Summary of the Davies (2013) case report

Study component

Description

Objectives/hypotheses

To evaluate the treatment of a painful leg ulcer with a novel compression device.

Study design

Retrospective descriptive case report.

Setting

Not stated. Patient treatment with the Juxta CURES commenced in 2013.

Inclusion/exclusion criteria

Not applicable

Primary outcomes

Not applicable

Statistical methods

Not applicable

Participants

73-year-old male with a VLU on the left leg that had not healed in 18 months. Medical assessment and ABPI indicated the wound was suitable for compression bandaging therapy. Multi‑layer compression started in September 2011 but discontinued in October 2012 at patient request due to pain and sleep disturbance. The patient had a pain score of 10 at night (0=no pain, 10=worst pain) and was taking strong opiate analgesia and antidepressants.

Description

The VLU was treated with the Juxta CURES, with pressure adjusted, if not tolerated, by the patient and could be removed at night when the pain was severe.

Results

After 4 days the patient reported the device was comfortable and allowed him to sleep through the night. Oedema had reduced by 9 cm at the ankle and 6.5 cm at the calf. The wound appeared unchanged.

After 14 days the patient stated the treatment had transformed his life. The patient reported minimal pain levels (score 1–2) and no longer required regular analgesia; antidepressants were also discontinued. Reduced pressure was maintained through the night. At 8‑week follow-up, the wound had healed.

Conclusions

This simple adjustable self-management compression device maintained the therapeutic levels of compression necessary day and night for the healing of venous leg ulcers thereby improving patient quality of life.

Abbreviations: ABPI, ankle brachial pressure index; VLU, venous leg ulcer.

Table 3 Summary of the Dowsett and Elson (2013) case reports

Study component

Description

Objectives/hypotheses

To assess whether quality-of-life issues could be addressed by treatment with the Juxta CURES.

Study design

Retrospective descriptive case reports on 2 patients.

Setting

Patients treated with Juxta CURES in a UK community setting between 2010 and 2012.

Inclusion/exclusion criteria

Not applicable

Primary outcomes

Not applicable

Statistical methods

Not applicable

Participants

Case 1: a 47-year-old male with a 10‑year history of bilateral VLUs. A variety of compression systems had been used on his legs but he admitted non-compliance due to the impact on his employment caused by the need to take unpaid leave to attend clinic appointments. He was experiencing malodour, extreme pain and depression. When at home he spent his time lying on the bed elevating his legs as instructed by his nurse.

Case 2: a 63-year-old woman with a 42‑year history of VLUs. A variety of compression systems had been used and all of those required daily treatment due to bandage slippage or high exudate levels. Her 'inverted champagne bottle' shaped leg, with a large calf and a relatively small ankle circumference, proved complex to manage. The patient's quality of life was severely affected due to high levels of exudate and repeat episodes of cellulitis resulting in her becoming housebound. Her 30‑year‑old son left full‑time employment to become her carer.

Description

Case 1: Patient applied the Juxta CURES, checked by the nurse at appropriate intervals.

Case 2: The Juxta CURES initially applied to the right leg and then also to the left leg with dressings changed once or twice a week as needed.

Results

Case 1: After 8 months use of the Juxta CURES, the ulcer was completely healed. The patient's quality of life dramatically improved, his pain and depression disappeared and he resumed normal work.

Case 2: The Juxta CURES was applied to the patient's right leg as this was the least severely affected. The patient was pleased to be able to wear non-orthotic shoes. Swelling reduced and there were signs of improvement to the wound, and the patient asked for a second device for her left leg. Both legs continued to heal. Nursing time was reduced from 90 minutes per week to 20 minutes per week. The patient's condition improved to the point where she no longer needed a carer and her son could plan a return to work.

Conclusions

The Juxta CURES assisted in improving patient wellbeing while still maintaining therapeutic levels of compression.

Abbreviations: VLU, venous leg ulcer.

Table 4 Summary of the Elson (2012) case series

Study component

Description

Objectives/hypotheses

To compare the costs of treating venous ulcers with compression bandages compared with the Juxta CURES.

Study design

A multicentre, prospective case series (17 patients).

Setting

UK Healthcare centres.

Inclusion/exclusion criteria

Not reported

Primary outcomes

Not reported

Statistical methods

Not applicable

Participants

17 patients, average length of time ulcer present = 7 years.

Description

Each clinician recorded 6 months of data of standard compression therapy and 6 months of Juxta CURES use including:

  • number of nurse visits

  • patient quality of life

  • type and number of wound dressings used

  • compression bandaging type and number used.

During 6 months of treatment with standard care before testing the new device, all ulcers remained static or deteriorated.

Where the patient had not used the compression garment for 6 months an estimate was made. This data was used to calculate and compare the costs of the 2 treatment options.

Results

After 6 months of treatment with the Juxta CURES all patients showed improvement in the condition of their leg ulcers. Patients and clinicians all gave positive feedback. Other results are summarised in the 'published cost studies' section.

Conclusions

The Juxta CURES proved cost effective when compared to standard compression bandaging, with improved leg ulcer condition at significantly lower cost.

Table 5 Summary of the Harris (2013) case series

Study component

Description

Objectives/hypotheses

Using the Juxta CURES can eliminate issues associated with leg ulceration and provide the clinician with an easy alternative. It can improve quality of healthcare and reduce costs.

Study design

Retrospective descriptive case series of 14 non‑consecutive patients.

Setting

Community setting – 7 patients seen in the leg ulcer clinic, 7 patients seen at home.

Inclusion/exclusion criteria

Not reported

Primary outcomes

Not reported

Statistical methods

Not applicable

Participants

n=14

9 patients with venous leg ulcers, 5 patients with leg ulcers of mixed aetiology (one patient had ulcers on both legs). Duration of leg ulceration ranged from new onset to 2.5 years.

Description

A mix of new patient referrals and patients already having conventional compression therapy. All patients were offered the Juxta CURES with compression levels ranging from 20 mmHg to 40 mmHg as suited to their ABPI and clinical presentation.

Results

All patients experienced improvements in their wounds and in skin integrity. The system was tolerated by 11 patients at the same or higher compression than previously used and 3 patients changed to alternative compression systems. Five patients' wounds progressed to healing in the 10‑week study period, and 4 were able to self–manage, resulting in reduced nursing time. Three chose to keep using the Juxta CURES after healing.

Clinicians particularly valued being able to accurately measure the compression levels through the built-in pressure measurement system. 96% of clinicians reported the fit, ease of application, application time and use of the built-in pressure system as very good or excellent. Clinicians reported reduced nurse time applying the Juxta CURES compared to conventional compression bandaging. A cost saving was realised after 12 weeks use of Juxta CURES in replacement of compression bandaging. Over 6 months use there was a cost saving of £2141 per patient.

Conclusions

Improved quality of life and wound healing was seen in 12 out of 14 patients. The Juxta CURES provided patients and clinicians with solutions to the problems associated with conventional compression therapy. Use of the Juxta CURES promoted self-care and resulted in financial savings compared to conventional compression bandaging, and a reduction in materials (for example, bandaging), nurse time and clinical waste.

Abbreviations: ABPI, ankle brachial pressure index; n, number of patients.

Table 6 Summary of the Lawrence (2014a) case reports

Study component

Description

Objectives/hypotheses

To illustrate how finding a compression regime that individuals can adopt without discomfort while being able to wear their usual footwear is important for many patients, and this can help maintain mobility and improve concordance.

Study design

Retrospective descriptive case reports on 3 patients.

Setting

Community setting in the UK.

Inclusion/exclusion criteria

Not applicable

Primary outcomes

Not reported

Statistical methods

Not applicable

Participants

n=3

Case 1: a 52-year-old woman with a 10‑year on–off history of VLUs and normal ABPI. She had self‑treated for almost 2 years before referral with a VLU measuring 8 cm x 5 cm.

Case 2: a 33-year-old morbidly obese man with a 6‑month ulcer history and normal ABPI. On examination, venous disease and associated oedema were present. Initial ulcer measurement was 12 cm × 10 cm; the ulcer was superficial with a low exudate level.

Case 3: an 82-year-old man with bilateral weeping oedematous legs and feet and 2 ulcers on his left leg. The patient also had type 2 diabetes and poor mobility caused by osteoarthritis and previous ankle injury and exacerbated by pain from leg ulcers. He also suffered peripheral vascular disease, foot neuropathy and reduced ABPI: 0.64 (left leg) and 0.75 (right leg).

Description

Case 1: 4-layer compression bandaging at 40 mmHg was applied for approximately 1 month, during which time the patient was unable to wear footwear suitable for her employment and lost her job. New work commitments meant she became unable to attend clinics and the ulcer remained static. Therefore the Juxta CURES was considered as the patient could learn how to change her own dressings and reduce clinic visits. It was used after dressing with Aquacel foam and Cavalon No Sting Barrier was used to protect the periulcer area.

Case 2: Bandages were applied, but proved difficult due to leg shape. 4‑layer and 2‑layer methods were trialled but removed by the patient due to slippage and discomfort. These bandages also made wearing a suit and dress shoes difficult and bandage slippage was embarrassing to the patient. The patient also reported malodour which he attributed to infrequency of dressing changes. The limb was too large for compression hosiery and the Juxta CURES was used to provide compression with Atrauman dressings.

Case 3: Reduced compression was prescribed but was painful, especially over the left ankle which had metal implants following a previous injury. Even highly absorbent dressings became saturated with exudate within a day and needed changing. Compression was stopped and replaced with the Juxta CURES at 20 mmHg with Aquacel dressings which the patient was able to tolerate.

Results

Case 1: The patient was able to self-manage the Juxta CURES bandages whilst still working and attended clinics when possible. The wound reduced in size to 2 cm x 2 cm (time period not stated).

Case 2: The patients' ulcer responded well, healed completely and had remained healed at 12 months follow‑up. Off‑the‑shelf standard compression stockings were provided for maintenance.

Case 3: The Juxta CURES required frequent readjustment over the first 2 days to maintain a good fit whilst the oedema reduced rapidly. The ulcers still remained at the time of reporting, but oedema and wetness had resolved. The patient tried to use compression hosiery on his right leg again but weeping resumed so he continued with the Juxta CURES to maintain skin integrity.

Conclusions

The Juxta CURES is useful for patients with large lower limbs and narrow ankles who struggle with bandage and hosiery slippage. It is beneficial for patients who wish to self‑treat or are unable to attend regular clinic appointments. It provides and maintains therapeutic compression at the desired, measurable level. Patients find it comfortable to wear and it could help improve compliance with treatment.

Abbreviations: ABPI, ankle brachial pressure index; n, number of patients;

VLU, venous leg ulcer.

Table 7 Summary of the Lurie et al. (2012) case series

Study component

Description

Objectives/hypotheses

To determine the suitability of the Juxta CURES as a compression device for the treatment of VLUs.

Study design

Retrospective descriptive case series of 10 non‑consecutive patients.

Setting

Vein Clinic, Hawaii.

Inclusion/exclusion criteria

Not reported

Primary outcomes

Clinician and patient satisfaction and therapeutic effectiveness.

Statistical methods

Not applicable

Participants

n=10

8 male, 2 female patients aged between 26 and 92 years.

Description

Patients wore the Juxta CURES over an appropriate wound dressing and a sock liner in combination with a compression anklet for the foot. Regular check-ups and wound dressing changes were undertaken. 8 patients wore the device all day every day; 2 patients wore the system continuously for 1 week and then for 12 hours during the day, every day thereafter.

Results

2 patients withdrew due to unrelated causes. The ulcers of the remaining 8 patients all healed in an average of 66 days after starting use of the Juxta CURES.

Conclusions

Clinicians found the Juxta CURES easy and quick to fit and remarked that it provided a good fit. Patients reported it was comfortable to wear, controlled swelling and allowed maintenance of hygiene. Clinicians evaluated the change in patients' oedema and skin, patient compliance and overall ulcer healing as excellent.

Abbreviations: n, number of patients; VLU, venous leg ulcer.

Table 8 Summary of the Nugent (2013) case report

Study component

Description

Objectives/hypotheses

To demonstrate how the Juxta CURES has had a positive impact on the patient's quality of life.

Study design

Retrospective descriptive case report.

Setting

Community setting in the UK.

Inclusion/exclusion criteria

Not applicable

Primary outcomes

Positive impact on patient quality of life.

Statistical methods

Not applicable

Participants

n=1

A 48-year-old man with a 12‑month history of a non‑healing ulcer 20 cm × 10 cm which, although extensive, was fairly superficial. The patient was classed as non‑concordant as he declined to attend appointments because they clashed with his work schedule. This is likely to be the same patient as described in the study by Bianchi (2013).

Description

The patient started self-managing his wound care in November 2012. Initially he used a 2‑layer compression system. This was changed to the Juxta CURES in November 2012, as the tissue viability nurse had concerns about the correct level of compression being reached at each application. The Juxta CURES was used in combination with a skin care and dressing regime comprising of Cetraben emollient cream and DryMax EXTRA. The patient was shown how to apply the Juxta CURES and use the built-in pressure system to ensure the correct level of compression (40 mmHg) was maintained throughout the week between appointments.

Results

After 1 week the patient reported that the device was comfortable and easy to use. After 3 weeks wound size had reduced significantly, although there were signs of overgranulation. By week 5 the wound size had decreased by 50%, the wound area to the lateral and posterior aspects had healed and the overgranulation had settled. At week 7, 4 superficial granulating areas remained. Further improvement was seen at week 10, when just 3 superficial granulating areas remained and these measured 3 cm × 2.8 cm, 1.4 cm × 1.6 cm and 2.9 cm × 1.9 cm.

The patient enjoyed being in control of the wound management process and knowing that, if there was odour from the wound, he could shower and change the dressing. The ability to wear his own shoes was a bonus.

Conclusions

Use of the Juxta CURES had a positive impact on the patient, and he found using the device a positive experience.

Abbreviations: n, number of patients.

Table 9 Summary of the Oates et al. (2013) case series

Study component

Description

Objectives/hypotheses

To enable patients to continue gold standard compression therapy treatment while allowing a higher degree of independence.

Study design

Case series (unclear if prospective or retrospective).

Setting

Community setting.

Inclusion/exclusion criteria

Not reported

Primary outcomes

Not reported

Statistical methods

Not applicable

Participants

n = not reported

Patients with venous leg ulceration currently being treated with compression bandages were invited to change to the Juxta CURES.

Results

The study reported a measurable reduction in wound size and leg oedema, improved patient concordance and wellbeing and a heightened sense of achievement for the nurses managing the patient. Costs and nursing time were noticeably reduced. Patient concordance was found to be much higher with the Juxta CURES than with comparable bandaging systems. Ease of use, the ability to reduce the pressure at night and to remove the device to take a shower being among the perceived benefits. The enhanced possibilities for patient self‑management also resulted in a lower number of district nurse visits being needed, bringing further reductions in cost.

Description

No methods stated.

Conclusions

The use of the device delivered significant benefits for both patients and staff in terms of better concordance, clinical effectiveness and cost reduction.

Abbreviations: n, number of patients.

Recent and ongoing studies

A UK study of 36 patients treated with the Juxta CURES has recently been completed. This data is expected to be published in May 2015.

Costs and resource consequences

In 2014 approximately 3,000 Juxta CURES devices were dispensed on prescription, with 86% of these prescribed by primary care clinicians and 14% by secondary care clinicians. The device has been used in approximately 15 locations across the NHS in England and is also used in leg clubs in Wales. The use of the Juxta CURES would not require any change to existing NHS facilities and would fit into the current care pathways, and can be prescribed on an FP10 prescription.

Current guidelines advise that standard compression therapy should only be applied by staff with appropriate training (RCN 2006; SIGN 2010), but the level of training needed is not specified. A standard pathway for prescribing compression therapy is also not specified.

Although the device has a higher acquisition cost than traditional compression bandages, it is anticipated that over the 6‑month minimum life‑span of the product, cost savings may be seen in the reduction of clinician time (reduced numbers of home or clinic visits and shorter visits), reduced amount of dressings and bandages needed and a resultant reduction in clinical waste.

Published cost studies

A case report on 3 patients (Bianchi et al. 2013) reported cost savings with the Juxta CURES compared with conventional bandaging over a 6‑month period. This was based on an evaluation of 17 patients and illustrated costs in 3 areas:

  • dressings: average saving of £753 per patient

  • bandages: average saving of £881 per patient

  • clinician time: average saving of £3172 per patient.

This would equal a total average saving of £4806 per patient. The study suggests that the use of the Juxta CURES results in reduced exudate, meaning that expensive extra‑absorbent dressings are not needed. Its use also appears to be cheaper than repeat bandaging and reduces clinical waste. The reduction in clinician time arises from faster application during clinic visits and a reduction in the number of clinic and home visits as the patient is encouraged to self-manage their care. The timeframe for this saving is not specified but is assumed to be over the course of 6 months. The source of these costs savings is not specified.

A poster presentation by Elson (2012) contained a product evaluation to compare the cost of treating venous ulcers with compression bandages with the Juxta CURES. Clinicians treating 17 patients recorded 6 months of data using standard compression therapy and 6 months using the Juxta CURES. Where the patient had not used the compression garment for 6 months an estimate was made. The data recorded included:

  • number of nurse visits

  • patient quality of life

  • type and number of wound dressings used

  • compression bandaging type and number used.

The data were used to calculate and compare the costs of the 2 treatment options. These costs are detailed below in table 10.

Table 10 Summary of the cost evaluation from Elson (2012)

Costs associated with the care of 17 leg ulcer patients

Treatment

Average cost

Dressings under compression

Standard compression treatment

£826

Treatment with the Juxta CURES

£72

Compression treatment

Standard compression treatment

£1073

Treatment with the Juxta CURES

£193

Associated nursing costs

Standard compression treatment

£4671

Treatment with the Juxta CURES

£1497

Using these calculations, total included costs for standard care are £6570 and £1762 for the Juxta CURES. This would provide an average saving of £4808 for the 17 patients equating to £282.82 per patient. The timeframe for this saving is not specified but is it assumed to be over a 6‑month period. The sources of costing prices are not specified.

Harris (2013) reported that a positive cost saving was realised at week 12 after the initial outlay to purchase the Juxta CURES.

A case report by Nugent (2013) detailed treatment of a patient treated with the Juxta CURES, whose ulcer was previously treated unsuccessfully with compression bandages. The cost of the previous 12‑months' treatment before assessment prior to use with the Juxta CURES was calculated at over £3300 with no healing of the ulcer. After reassessment and commencement of the Juxta CURES, the ulcer reached an almost‑healed state before reporting at an estimated cost of £732. The time period for this estimated cost is not stated but is assumed to be for the 10 weeks during which the patient was treated with the Juxta CURES.

Strengths and limitations of the evidence

The identified evidence for the clinical effectiveness of the Juxta CURES was very limited in both quantity and quality, and comprised published case reports, abstracts and poster presentations. No large‑scale studies, or robust comparative data were identified.

All of the included studies involved small numbers of patients (the maximum specified was 17). Five studies (Bianchi et al. 2013; Davies 2013; Dowsett and Elson 2013; Lawrence 2014a; Nugent et al. 2013) are case studies of 3 patients or fewer, and therefore it can be assumed that the outcomes of these studies should not be generalised.

It is unclear whether patients in the identified studies were enrolled consecutively; this raises concerns about selection and attrition bias. Five studies are not reported in full, and are available only as posters or abstracts and have not undergone peer review. This includes the 4 case series (Elson 2012, Harris 2013, Lurie et al. 2012 and Oates et al. 2013). Inclusion and exclusion criteria are not clearly stated for these case series, and only Lurie et al. (2012) state primary outcomes. The lack of available detail means that these results should be treated with caution.

It is highly likely that the patient reported by Nugent (2013) is the same as 1 patient reported in the Bianchi et al. (2013) paper, of which Nugent is a co‑author.

Seven of the 9 studies contain acknowledgements to medi UK or have authors employed by medi UK or CircAid.

Economic reporting is limited and the sources of the costs and assumptions made are not specified, therefore it is not possible to assess their appropriateness. Variability of the cost saving between each study suggests that these results may not be generalisable. However all reports suggest the device is cost saving compared to compression bandaging.