FREMS Neurovascular Rehabilitation: effective innovation for the treatment of peripheral neurovascular complications (#2076)

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Idea Description
Supplementary Information
Detailed Submission Data
Innovation 'Elevator Pitch':
The FREMS Solution is an effective means of combating neuropathic pain in diabetics with clinical trials showing the benefit persists at the 4 month follow up.  For chronic ulcers FREMS restores perilesional perfusion and rapidly reduces pain.
Overview of Innovation:
FREMS is the result of research dedicated to realise a non pharmacologic system able to treat vascular and neurological diseases such as diabetic neuropathy.
 
FREMS is a new-generation biocompatible electrical neurostimulation.  The healing effects of FREMS occur through a direct and indirect action on the biological control systems and especially in the autonomic system.
 
FREMS works thanks to a series of two-phase, asymmetrical and electrically balanced electrical pulses: a “simultaneous modulation’ of pulse Frequency, Amplitude and Duration.  FREMS is an innovative, proven and easy-to-apply treatment method against pain.
 
FREMS is delivered via Aptiva and Satellite medical devices with dedicated transcutaneous electrodes for clean and simple application without side effects.  The treatment involves a series of 30 minute daily sessions over a few weeks that can be performed both at hospital or at home.
 
As demonstrated by studies performed in recent years, FREMS delivers pulse sequences that can significantly increase the release of plasmatic growth factors.  The analysis of systemic blood samples in diabetics and non-diabetics, taken before, during and after FREMS neurostimulation, has shown increases in the levels of VEGF and other angiogenetic growth factors.
 
For painful chronic leg ulcers FREMS significantly promotes epithelisation and decreases pain levels after as little as 36-48h with no side-effects.  It has long-lasting effects which can be seen 2 months after the end of treatment and significant accelerates healing times.
 
For various etiologies of chronic leg ulcers FREMS can be a valid method of healing chronic cutaneous ulcers with significant reductions in area and depth a few weeks after commencing FREMS.  The treatment increases the quality of assistance and the quality of life of the patient.
 
For painful Diabetic neuropathies FREMS provides safe and effective treatment for neuropathic pain in diabetics and can modify some functionality parameters of the peripheral nerves such as an increase in tactile sensorial perception and in the speed of conduction of the motor nerve.  The clinical effects persist at the 4 month follow-up.
 
For arteriopathy FREMS has significant effects on diabetics with PAD; increase in oxymetric values at the 3-month follow-up; increase in walking distance free of pain at the 3 month follow up; improvement in the characteristic parameters of the endothelial system.
Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
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Innovation 'Elevator Pitch':
Woundex is a innovative breakthrough discovery, the only product in the world which efficiently works on all types skin ulcerations, and is one of the best treatments available.
Overview of Innovation:
Diabetic foot problems, such as ulcerations, infections, and gangrene, are the most common cause of hospitalization among diabetic patients. Routine ulcer care, treatment of infections, amputations, and hospitalizations cost billions of pounds every year and place a tremendous burden on the health care system.
 
This therapy will help save the psychological distress people go through when they have amputations. This treatment will reduce the monetary burden on the national health care system. It has shown good results, even on the severe cases of ulcerations.

It has no side reactions. This product can be used in all types of skin ulcerations , open wounds, burns, gangrene  and diabetic ulcers. Patients would be saved from having an amputation.
This product on application helps increase blood circulation around the wound area .It also increases and promotes tissue growth this in turn helps to heal the wound speedily.

 if it is cut, however, in some people with diabetes the skin on the feet does not heal so well and is prone to developing ulcer. This can be even after a mild injury such as stepping on a small stone in your bare feet.
There is reduced sensation of the skin on your feet. Your nerves may not work as well as normal because even a slightly high blood sugar level can, overtime damage some of your nerves. This is a complication of diabetes called peripheral neuropathy of diabetes.
Diabetic ulcers can lead to gangrene , amputation making the patient immobile.
This causes great psychological distress for the patient.
 
Diabetic foot ulcer places a big budgetary burden on the healthcare authorities. Along with treatment of foot ulcers, amputation  the cost are substantial.
The healthcare authorities have to employ multidisciplinary foot care services led by healthcare professionals, and this consist of specialists with skills in the following areas: Diabetology, Podiatry, Diabetes specialist nursing, Orthopaedic surgery, Biomechanics and orthoses, Interventional radiology, Casting and Wound care-putting an even greater financial strain on the heathcare provider.
 
Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
WMAHSN priorities and themes addressed: 
Mental Health: recovery, crisis and prevention / Long term conditions: a whole system, person-centred approach / Advanced diagnostics, genomics and precision medicine / Wellness and prevention of illness / Clinical trials and evidence / Innovation and adoption / Person centred care
Benefit to NHS:
Diabetes ulcer and amputations cost £1 in every £150 spent in the NHS budget. Around 15 % of all diabetes patients will suffer from diabetic ulcer and at a advanced stage amputations have to be carried out.  There are currently 150 amputations performed every week in the UK.  Patients who  have diabetic ulcers are given antibiotics as treatment to control the ulcer. These are given over many years. As you may be aware of there is a big problem of antibiotic resistance.
There will be big benefit to the NHS if they use this treatment.
Benefit to WM population:
This Treatment will benefit the WM population in big way and will eleviate the suffering diabetic ulcer patients go through.
Current and planned activity: 
The medicine is a phyto chemical spirit based solution and has to be imported from India. This medicines ingredients can only be grown in India. At the present time this product is being licenced in India
What is the intellectual property status of your innovation?:
At this stage no status
Return on Investment (£ Value): 
Very high
Return on Investment (Timescale): 
0-6 mon
Ease of scalability: 
Simple
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Innovation 'Elevator Pitch':
The Silhouette® solution enables integrated care ,closer to home, for patients with diabetic foot ulcers, using digital wound imaging and objective wound healing data available remotely in real time, to improve patient care and reduce system costs.
Overview of Innovation:
Digital Silhouette® solution for diabetes foot management improves clinical objectivity and patient experience 
 
Diabetes is a major health challenge in the UK with a rapidly increasing number of people affected. Active disease of the foot is a crisis situation for a patient with diabetes and requires timely referral and management. A proven solution for reliable and remote monitoring of diabetes foot ulcers, Silhouette, is available to support integrated care, releasing capacity in acute out-patient clinics and supporting safe care in community settings. 

An EMAHSN-supported demonstrator established with Derby Teaching Hospitals NHS Foundation Trust and Derbyshire Community Healthcare Services Trust has led to improvements in clinical management and patient experience:

Clinical Lead, Professor Fran Game, Consultant Diabetologist, Clinical Director R&D, Derby Teaching Hospitals NHS Foundation Trust:
“As a result of implementing the Silhouette system, we have been able to safely transfer an increasing portion of patients for treatment in community clinics and have improved waiting times in our out-patient clinic. Importantly, patients are happy with the new model of care. In a survey following introduction of digital ulcer assessment, 71% of patients reported a greater confidence in the care they had received.”
 
Service User, Patient Experience:
Patient A.S. from Kilburn said; “We only live just down the road from the clinic and it saves so much time for us, it is much closer to home than the hospital is, which means we are not spending so much time getting to and from appointments.”

Innovation Solution Deployed:
  • Silhouette® digital wound imaging & information system deployed as a telehealth solution, to build community capability for on-going treatment.
  • 3D measurement technology accurately maps ulcer size, enabling clinicians to assess wound progress & response to treatment with objective data
  • Enables reliable & remote monitoring of patients with active DFU & chronic complex wounds
Impacts to date:
  • EMAHSN independent qualitative and quantitative evaluation
    –Over-whelming improvement in patient experience
    –Positive feedback from clinicians
    –Reduction in acute Out-Patient over-crowding
     
    First year 462 (7.4%) appointments moved to community
    First year 5 camera, total investment £66k, first year savings £35k
    Business case based upon reduction in treatment/tariff costs

SilhouetteStar Camera


Dr Bruce Davey - CEO ARANZ Medical with SilhouetteStar Camera

 

 
Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
WMAHSN priorities and themes addressed: 
Long term conditions: a whole system, person-centred approach / Wealth creation / Digital health / Innovation and adoption / Patient and medicines safety / Person centred care
Benefit to NHS:
The Silhouette digital solution for diabetes foot management has been successfully deployed in an EMAHSN-supported Demonstrator. The deployment of Silhouette is enabling an integrated diabetes foot pathway in Southern Derbyshire , linking care across acute and community.
A Business Case is available on request from EMAHSN, please email Dara.Coppel@nottingham.ac.uk 
The reported benefits to date include:
Patient outcomes: Greater convenience for patients, through treatment in community, less time waiting, less travel, with remote oversight by specialists to provide joined up care
Efficiency gains: health care professionals can access the secure Silhouette digital data quickly and in real time allowing escalation and de-escalation from community to hospital based on objective clinical data on ulcer status and risk. Adminstration reduced with automated reporting of patient's ulcer treatment and progress to GPs, reducing admin time and cost of letters to GPs.
Cost-effectiveness: A shift of hospital treatment appointments to community, trending at 8% has yielded savings on tariff costs across whole system. Cost reduction on adminstration involved with reporting to GPs.  
Online Discussion Rating
5.00 (1 ratings)
Initial Review Rating
4.80 (2 ratings)
Benefit to WM population:
Health: Using objective clinical data on ulcer healing to building efficiency in acute out-patients, building community capability for care closer to home to support improvements in patient safety, experience and outcomes.
Wealth: Better use of NHS funds to enable staff to manage patients with a focus on outcomes rather than activity 
Growth of a UK SME to create jobs and new solutions for the NHS.
Current and planned activity: 
Current activity: 
Entec Health and ARANZ Medical are actively engaging with expansion of Silhouette deployment across Derbyshire county as part of the Derbyshire NHSE Diabetes Transformation programme. In addition, a number of other NHS Diabetes Foot Services are working with us to develop and deploy a Silhoeutte-enabled MDFT in Nottinghamshire and Cambridgeshire & Peterborough. These initiatives involve CCG /STP stakeholders to support sustainability plans for the innovation and transformation work for long-term gain for patients and the NHS.
Planned activity
We are seeking to work with CCGs/STPs and NHS Providers who have a vision for deploying Silhouette in diabetes foot ulcer management and chronic wound management to drive forward a patient-centred, outcomes-led, service. 
What is the intellectual property status of your innovation?:
Silhouette digital wound assessment and information management system is developed and manufactured by ARANZ Medical Limited, based in New Zealand, with ARANZ Medical Limited having ownership of IP for Silhouette brand and Silhouette technology.

 
Return on Investment (£ Value): 
medium
Return on Investment (Timescale): 
2 years
Ease of scalability: 
Simple
Regional Scalability:
Please describe how the innovation could be scaled across the WM region. Have you implemented at scale in any other regions?
Measures:
What outcomes are you hoping to achieve and what are the measures that you will use to gauge the success of the innovation and how will these assessments be made? Please ensure that you have quality, safety, cost and people measures.
Adoption target:
What are the targets for adoption across the WM and what are the minimum viability levels?
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Innovation 'Elevator Pitch':
Solesee is a foot inspection mirror designed for people with diabetes to help them see the whole of the bottom of their feet to check for cuts, grazes, dry skin & blisters. Solesee makes this much easier to achieve and encourages daily use.
Overview of Innovation:
The Solesee Foot Inspection Mirror has been specifically designed for people with diabetes to help them to see the whole of the bottom of their feet. With diabetes, people should be checking their feet every day for cuts, grazes, dry skin, blisters, changes to the colour and general condition, etc. Due to nerve and blood capillary damage caused by diabetes, people with the disease can develop peripheral neuropathy that reduces or removes any sensation or feeling in the feet.

If any break in the skin is not quickly noticed and treated, then it could become ulcerated. Ulcers are slow to heal and can quickly become infected. If this happens then the possibility of amputation is increased as the only means to treat the condition. In England alone there are over 140 diabetes relates lower limb amputations a week. Each ulcer can cost the NHS about £5,000 to treat. An amputation can cost £15,000 with the resulting rehabilitation of the patients costing a further £18,000.[Source: Diabetes UK].

Having a product like Solesee makes checking feet much easier to achieve and encourages daily use thereby helping to prevent problems occuring in the first place.  Solesee was developed, using input from both podiatrists and diabetes patients, as a result of hearing about the lack of anything simple and easy to use to check the soles of your feet every day. The key elements to Solesee are:
  • A large shatterproof mirror;
  • The mirror is set at the perfect angle to allow users to see the whole of the sole of their foot when in a seated position;
  • It folds into an iPad sized folder for easy carrying and storage
  • ​It has been designed and manufactured in the UK
  • It is design protected
A big part of what Solesee aims to do is educate people about making foot checks as regular a part of the morning and evening routine as cleaning your teeth. Part of this is consumer education through general awareness building, but it is also through getting the professional clinicians involved as they are the people who probably have most influence over the patients that they are seeing.

The National Diabetes Foot Co-ordinator for Scotland sees a clear role for clinicians to use Solesee in their clinics to not only show the patients what the soles of their feet look like (before, during & after treatment) but also to show them how to use Solesee - to encourage them to go and buy one and use it themselves.Taking ownership of their condition if you will. Wider clinical take-up and patient awareness is our key aim.
Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
WMAHSN priorities and themes addressed: 
Long term conditions: a whole system, person-centred approach / Wellness and prevention of illness / Person centred care
Benefit to NHS:
Due to nerve and blood capillary damage caused by diabetes, people with the disease can develop peripheral neuropathy that reduces or removes any sensation or feeling in their feet. As a result they are not able to feel if they have cut or damage to their feet in any way e.g.a stone in a shoe, a blister, a cut, a scold from hot bath water or burn from a radiator or open fire.

If any break in the skin is not quickly noticed and treated, then it could become ulcerated. Ulcers are slow to heal and can quickly become infected. If this happens then the possibility of amputation is increased as the only means to treat the condition.In England alone there are over 140 diabetes relates lower limb amputations a week. Each ulcer can cost the NHS about £5,000 to treat. An amputation can cost £15,000 with the resulting rehabilitation of the patients costing a further £18,000.[Source: Diabetes UK].

There are also other, hidden costs, that could manifest themselves in a wider health issue to the patient. Being incapacitated with a foot ulcer can lead to a lack of exercise, low morale, lack of social interaction (due to being housebound) and potentially a poor diet as a result. There is also the mental strain of not being able to get out and about. This can be multiplied when you consider the impact of having an amputation.

From general research and discussions with people who have diabetes, there appears to be a lack of understand about how diabetes really affects your feet. A number of people we spoke to indicated a degree of knowledge, but said they were 'happy to wait until a problem occurred' before really taking it seriously.  Other people had little idea why they should check their feet or even what to look for on their feet if they did check them.

Using Solesee to increase awareness and education, about how serious this condition is, leads to a greater chance that ulcers will not develop in the first place.  Even if a cut or ulcer did occur, the chances of getting it treated at an early enough stage are greatly increased if people are making ther own regular foot checks, especially if encouraged by professionals. A product like Solesee makes checking feet much easier and encourages daily use thereby helping to prevent problems occuring in the first place. Compare using Solesee to using a toothbrush. 30 years ago cleaning your teeth once a day was probably the norm.  Now people clean their teeth twice a day without thinking - and few people die from getting a cavity!
Initial Review Rating
2.60 (1 ratings)
Benefit to WM population:
The aim is to get every clinician, that deals with foot care related issues and education, using Solesee as part of their normal clinical practice.  Whenever a patient presents for an annual foot check or prior to/during treatment for any foot disorder, the clinician should use Solesee to show them what the sole of their foot looks like.  This can be a 'before' and 'after' treatment scenario, so the patients can see what the clinician has done.  It would also be useful for patients to know what signs of irregularity or infection they should be looking out for, if they need to change their dressings between appointments.

It can also be an means to educate patients what their feet should look and what they should be looking for prior to any issues occurring in the first place.  If there are indications that problems could occur, such as the start of dry skin or calluses, then the clinician can clearly highlight this to the patient with some advice about what they should do. 

In all the above cases the clinician should be able to recommend that the patient starts to make regular checks using a mirror, like Solesee, so they get used to seeing the bottom of their feet and what issues to be aware of and look out for.

In this way the level of education about foot related issues for people with diabetes will be raised.  The potential problems, and what that really means to the patient can be discussed in detail, and the frequency of diabetic foot related problems reduced in and around the clinics where it is practiced.

Birmingham has one of the highest incidences of diabetes in the country (according to a recent BBC Panorama programme) and as such has a lot to gain from better educating the patients about the potential foot related problems.  The cost of giving one Solesee 10,000 clinicians or patients is the equivalent to the cost of 56 individual ulcers being treated.  We would like to think that, out of 10,000 people using Solesee, that we could reduce the incidence of diabetes related ulcers by at least 56 patients!

All the above doesn't take into account the longer term benefits to the region. Reducing the incidence in ulcers will reduce days lost to sickness in industry, as well as the the other 'hidden' costs assocuated with someone who is incapacitated through not being able to walk or work.  This includes mental health related issues.
Current and planned activity: 
I have been speaking to Duncan Stang (the National Diabetes Foot Co-ordinator for Scotland) who sees a clear role for clinicians to use Solesee in their clinics to not only show the patients what the soles of their feet look like (before, during and after treatment) but also to show them how to use Solesee - to encourage them to go and buy one and use it themselves.  Taking ownership of their condition if you will.  I am in contact with Dr Jane McAdam (Head of prosthetics and podiatry at Salford University) and I am also trying to speak to Dr Paul Chadwick from Salford Royal Hospital NHS Fundation.

However I need to try and get a better access to the wider NHS and the clinicians who deal with diabetes patients on a regular basis e.g. GP's diabetes nurses, etc as well as the NHS podiatrists.  Getting professionals to use and recommend Solesee will help increase the awareness of the foot issues related to diabetes and hopefully increase the daily foot checks of patients. 
What is the intellectual property status of your innovation?:
Solesee is design protected and the brand name is a registered trade mark.
Return on Investment (£ Value): 
Very high
Return on Investment (Timescale): 
0-6 mon
Ease of scalability: 
Simple
Regional Scalability:
Scalability is simple as it is a self contained product.  Our only challenge would be to fund product production should there be a very large upswing in demand.  However this could be managed if we have POs from recognised organisations or bodies such as the NHS.
Measures:
The aim is to see a reduction in the number (percentage) of people that present themselves with a reoccurrance of a diabetic foot ulcer.  By taking a more proactive approach to daily footcare the chances of an ulcer reoccurring are significantly reduced.

To measure this, we would need a clinic to a group of patients who have previously had a diabetic foot ulcer that has been successfully treated.  They would then be split into two groups - those who are given a Solesee and shown how to use it and those that are told to check their feet but not given a Solesee to use.  The condition of their feet would be checked at the usual regular intervals over the course of a 6 month period to assess the condition of their feet.  The expected result is that group using the Solesee would see a lower reoccurance rate compared to those that were not given a Solesee to use.

We would also assess usability and product quality issues looking at both groups using more qualitative techniques.  We would want to assess how people found using Solesee on a daily basis and also what the people, who were not given a Solesee to use, did instead.

Using the approximate costs to treat an ulcer that have already been stated (to treat a foot ulcer on the NHS is about £5,000) we would look at developing a commercial case for that clinic based on the number of patients that have a diabetic foot condition, using the data produced from the trial.  This should give a firm commercial argument for investing in Solesee mirrors and prescribing them to pateints with diabetes and at a high risk of developing a foot ulcer.
Adoption target:
This is difficult to gauge as the number of people with diabetic foot conditions will vary from clinic to clinic.  To be able to price Solesee at a level that the NHS would feel is suitable, then there would need to be economies of scale as far as production is concerned.  This would mean a minimum order of about 1,000 units.
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Innovation 'Elevator Pitch':
Neurocare’s™ muscle stimulation  therapy is safe, comfortable, non-invasive and clinically proven to accelerate  wound healing and musculoskeletal  rehabilitation which enables major treatment  cost reduction with  significant increases in HRQoL.
Overview of Innovation:
Neurocare™are seeking to promote the adoption in the UK of their muscle stimulation device and its comprehensive treatment protocols .
 
Neuromuscular electronic stimulation therapy is well established in many countries in the world particularly in the U.S.A. and with six FDA indications has a strong clinical trial evidence base in most of its  applications.  The Canadian and American Health Authorities have recommended its use in healing pressure ulcers as did the EPUAP/NPUAP collaboration in work published in 2009.
 
Patient compliance is potentially a challenge particularly where adherence to a treatment programme over a period of time is necessary. Many muscle stimulation devices can be painful  when set at voltages required to achieve a therapeutic level of muscle recruitment.
 
The Neurocare™ device has a unique electronic configuration which features AC output and allows very high voltage for full muscle recruitment at very low amperage for pain free comfortable therapy. Whether treatment occurs in clinic or in the home the objective is to recruit the patient as an enthusiastic active participant in their own programme of therapy.
 
The Neurocare™ device functions by introducing an electrical signal into the motor nerve of the muscle causing a muscle contraction which replicates exercise whilst activating the peripheral arterial and vascular systems which are essential to moving freshly oxygenated blood through the wound site.
 
Each treatment lasts between 30 to 45 minutes and may be administered once or twice daily as necessary at a cost of approximately £2 per treatment.
 
As an option remote web-based management incorporating a “virtual clinic” allows home self-treatment without the presence of healthcare professionals facilitating much more intensive therapy than periodic clinic/outpatient visits allow. This has potential for substantial cost reductions and significant acceleration of healing wounds or musculoskeletal rehabilitation with consequent improvement in HRQoL and timescales reduction.
 
Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
WMAHSN priorities and themes addressed: 
Long term conditions: a whole system, person-centred approach / Wealth creation / Clinical trials and evidence / Innovation and adoption
Benefit to NHS:
As an adjunct therapy, NMES devices have been shown in clinical studies to reduce healing timescales compared with existing treatment pathways.  This is true of wound healing and musculoskeletal rehabilitation in general.
 
The Neurocare™  device is  simple,safe, non-invasive and comfortable. It is suitable for use in hospitals, clinics and the home and can be self-administered which permits both logistically and financially very much more intensive therapy than could be achieved with multiple visits to a clinic for outpatient treatment.
 
With the addition of the web-based management system the patient and Healthcare Professional can maintain constant contact for monitoring and management of the patient’s progress thus minimising the frequency of outpatient visits.
 
As an example diabetic ulcers are known to be slow healing. Six months plus  would be typical and many endure well in excess of one year. An adjunct therapy which can reduce  healing timescales by 25%+ and in many cases avoid patient episodes such as  revascularisation and amputation clearly reduces costs and radically improves the outcome for patients.
 
Many of the documents attached evidence the potential improvements accessible with this therapy which is very versatile and will bring more effective resource utilisation, cost reduction and improved patient outcomes across its very broad range of applications.
 
Web-enabled home self treatment accords well with NHS strategic priorities which stress the objective of bringing treatment closer to the patient and highlight the increasing importance of improving the patient experience.
 
Once established as a cost effective way of achieving wound healing the concept of using web-enabled treatment would be extended on a broad front. With NMES an extensive range of medical conditions can be treated remotely. The use of the Internet and the “Virtual Clinic” staffed by multi disciplinary experts allows scarce expert resources to be active over very large patient populations whilst simultaneously permits the patient to remain under the general care of their GP Practice.
Initial Review Rating
3.80 (3 ratings)
Benefit to WM population:
A healthy population is likely to be more productive than an unhealthy one and increasing productivity creates increasing wealth per capita. Healthcare delivered in the most productive way means that for each resource unit consumed more units of healthcare can be delivered.
 
Incremental productivity gains are largely driven by innovation but if maximum value is to be gained  proven innovation must be rapidly adopted and diffused.
 
Today’s aging population is increasingly frail and high quality care is increasingly expensive . Expectations will not be met if innovation driven productivity improvement stalls.
 
In a definitive NHS Document entitled ”Innovation Health and Wealth” published in Dec 2011, Innovation is defined as “An idea service or product new to the NHS or applied in a way that is new to the NHS, which significantly improves the quality of health and care wherever it is applied”. To this end the document recommends inter alia that the NHS should strive  to embrace innovation and become an early adopter, should make full  and early use of digital technologies and increasingly shift focus  toward early diagnosis and prevention,
 
The innovation proposed in this document accords well with these aspirations in that we are proposing the widespread adoption and diffusion of a clinically proven but as yet sparsely adopted medical technology supported by a state of art web-based management system.
 
Healing diabetic ulcers with home self-treatment has been chosen to illustrate the potential of web enabled management of NMES therapy  in this document but the same principles may be applied wherever this form of therapy has proven efficacy.
 
Effective prevention is difficult to prove clinically but several trials have shown that pressure ulcers can be prevented using NMES and the restoration of muscle strength and balance may extend self sufficient independence and thus delay nursing home and/or inpatient costs.
 
The way is open for CCGs to finance adoption trials at relatively low cost and risk pending widespread diffusion.
 
Current and planned activity: 
We are working with
1). Prof. Michael Edmonds at the Diabetic Foot Clinic - Kings College London.
2). Mr. David Russell at the Limb Salvage Clinic - Leeds NHS Trust
3). Prof. Ian Chetter - Vascular Surgeon at Hull NHS Trust

preparing an application for RfPB.

We also recently participated with other NHS hospitals & their Test Beds applications. We are continuing work with the Leeds Academic Health Network.
 
We are currently also working with four further AHSNs; East Midlands, West Midlands, West of England, Yorkshire and Humber.
  • Evaluation / Validation / Clinical Trial - Need to gain additional validation of system within the UK – Thus seeking a trial centre.
    Leading to:
  • Procurement / Adoption - Require addition assistance and validation to support UK sales and marketing to UK treatment centres within Acute and Primary sectors
What is the intellectual property status of your innovation?:
The device IP belongs to Neurocare Europe Limited under license from Neurocare  Inc USA.  
Return on Investment (£ Value): 
Very high
Return on Investment (Timescale): 
1 year
Ease of scalability: 
Simple
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Innovation 'Elevator Pitch':
Intensive home self-treatment of  chronic conditions  with a safe, clinically proven therapy advised    by HCPs acting remotely within a web based  “Virtual  Clinic" brings  treatment cost reduction and improves HRQoL. 
 
Overview of Innovation:
The proposed innovation establishes a partnership between the local clinicians, individual patients, Neurocare™ Europe who supply the Electrotherapy Device and Neurocare's™ partner Idieikon who have developed the web based Health and Social care management system.

There are three dimensions to the Innovation proposed.  Firstly the "Virtual Clinic" requires the specification of an appropriate mix of medical skills to man the clinic according to the condition(s) intended to be treated.

Secondly the principal therapy chosen must be safe, comfortable, suitable for home self treatment and clinically proven in the applications proposed .
 
Thirdly the patient cohort must be motivated and sufficiently computer literate to make appropriate use of the "Virtual Clinic" and to follow treatment protocols for the Therapy Device.

The Patient will also self monitor progress (in the example of treating leg ulcers) by such means as taking and uploading photographs of wound size reduction, completing  self reporting inventories for example of pain increase or decrease and undertaking any further monitoring  as required by clinicians.

Whilst any form of therapy could potentially be used within the "Virtual Clinic" concept providing it met the essential  safety and efficacy criteria. Electrotherapy, particularly Neuromuscular Electronic Stimulation has been chosen to illustrate the operation of the concept since it has a broad range of clinical evidence supporting its use in  treating many conditions where improving blood circulation,  increasing joint range of motion, improving muscle bulk and strength, resolving muscle spasms and avoiding atrophy are key to a successful outcome for the patient.

Circulatory and musculoskeletal conditions are frequently part of the aetiology of those affecting mobility and self sufficiency in later life, treatment of which in a clinical setting can be labour intensive and involve much inconvenient travel for the Patient. In addition to dermal wound healing we would expect that the concept could readily be used in  rehabilitation post stroke and post major orthopaedic surgery e.g. TKA and post bone fracture where early and intensive treatment is essential  for pre-disablement strength and mobility to be restored.

Recent clinical studies have also shown that NMES therapy can counter Sarcopenia and restore muscle mass and strength and improve balance thus enabling the elderly to remain self-sufficient in their own homes for longer.
Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
WMAHSN priorities and themes addressed: 
Long term conditions: a whole system, person-centred approach / Wellness and prevention of illness / Wealth creation / Clinical trials and evidence / Digital health / Innovation and adoption / Person centred care
Benefit to NHS:
The three distinct aspects of the innovation proposed, Electrotherapy, Home self-treatment and the use of a “Virtual Clinic” if  adopted separately will each  improve patient outcomes, produce efficiency improvements and  be cost effective. When deployed together following patient involvement and consultation designed to improve patient activation and  reinforced by the use of patient reported outcome measures (PREMS)  further synergistic gains are anticipated.

NMES is used to treat many chronic conditions. Clinical evidence is strong in dermal wound healing (paper attached) in rehabilitation post major orthopaedic surgery e.g. TKA, ligament reconstruction etc., (paper attached). In other applications such as Arthritis, COPD, Neuropathy, and Sarcopenia   evidence  is positive but not yet conclusive.

In wound healing and rehabilitation NMES has been shown to accelerate healing timescales when used as an  adjunct to standard treatment pathways where timescales are long, labour intensive and incur high consumable costs.  Faster healing brings lower costs and in situations where the wound condition may have worsened (e.g. diabetic ulcers which can escalate into amputation) additional costs can be avoided and  the patient experience radically improved.

The use of Neurocare™ NMES therapy is safe and comfortable. The device proposed for this innovation is of unique electronic design in that it produces an AC signal of up to 400 volts at less than 10 milliamps. This allows full recruitment of local musculature for effective therapy. Inherent ease of application makes the therapy very suitable for home self-treatment which can be delivered intensively.

The use of the “Virtual Clinic” means that home self-treatment can be closely monitored by HCPs who are able to interact as necessary throughout the course of therapy. Self-measurement and regular dialogue should reduce the need for, and inconvenience of clinic attendance and save cost.

The “Virtual Clinic” is an additional feature of the Adsum+ Health and Social Care Management System which is a comprehensive platform designed to facilitate proactive and integrated care and  enhance efficiency. Amongst a full range of advanced features Adsum+ software identifies, co-ordinates and manages the activities of each person/organisation involved in the care plan, tracks activity and flags up missed or incomplete events so that remedial action can be taken.
Initial Review Rating
4.60 (1 ratings)
Benefit to WM population:
The wealth of any nation and the health of  its population  are inter-related in complex  ways. Increases in wealth and improvements in health require  continuously rising unit productivity which in turn requires  continuous  innovation.

In the NHS , against a  backcloth of rising unit costs and  rising demand for services across the entire   healthcare spectrum, the consensus on  necessary change highlights a required new emphasis on proactive care and prevention, patient centredness, more effective integration and coordination within and between HCPs and Healthcare Organisations  and a radical reorganisation of the healthcare/social care interface together with an emphasis on chronic conditions and enabling elderly people to live independently.

We believe that the proposal contained in this paper can contribute in the following ways:
The use of electrotherapy in one of the proposed applications suggested  will demonstrate that this form of treatment on an intensive basis in a surgery, clinic or the home can significantly reduce healing timescales and costs and in many cases can be used as a preventive treatment.  It will also show that guided self-treatment is viable in many situations, particularly in treating certain chronic conditions.

Major new system implementations such as Adsum+ are often used  as a vehicle for facilitating and driving far wider ranging change in management processes and organisational culture. Implementation of this proposal contains the tools and the potential to facilitate the far deeper and broader changes required.

Technology enabled care usually defined as telehealth and telecare can play a valuable role in this transformation but the real value added gains may lie in the widespread take-up of “Virtual Clinics” and similar concepts  which put the patient at the centre of  the treatment plan.

Raising the level of  knowledge and engagement amongst the  patient population together with developing a capability to take more responsibility for their own health is crucial. The key is to convert passive recipients of reactive care into active knowledgeable participants in the management of their own general treatment when necessary.

The deployment of innovative, proven therapies locally or in the home, enabled and jointly managed by providers and recipients in the form of a “Virtual Clinic” will prove a powerful contributor to  improving health states and thereby create increasing wealth.
Current and planned activity: 
We are involved with The NHS within the Vanguard Initiative. This is at a very preliminary stage and we would welcome any assistance to accelerate this work.

We are collaborating with three Clinicians (Prof Mike Edmonds at Kings College Hospital is PI) in preparing an application to the NIHR Research for Patient Benefit funding stream. As presently constituted this will be a three centre clinical trial of web enabled home self treatment of recalcitrant diabetic foot ulcers.

In the EU we are in the process of appointing Distributors in several countries and are also involved in the HAPPI project
In the  Middle East  we are working in Iraq and Iran with new Distributors.

On a general basis we would like to hear from Clinicians/CCGs interested in any application of NMES with a view to organising adoption pilots. This could be stand alone or in conjunction with the “Virtual Clinic” concept with treatment given either in clinic, in the home, or in the Nursing Home.
What is the intellectual property status of your innovation?:
The IP in the Neurocare™ NC2000 device is owned by Neurocare™ Inc. of Salem Oregon and licenced exclusively to Neurocare™ Europe Limited. All treatment protocols are copyright.
Return on Investment (£ Value): 
high
Return on Investment (Timescale): 
6-12 mon
Ease of scalability: 
Simple
Regional Scalability:
This will depend upon the healthcare priorities identified within the West Midlands region, since the therapy as noted in the original document has several clinically  proven applications particularly in relation to chronic conditions.
 
Two of the West Midlands priorities are the Treatment of Long Term Conditions and the Promotion of Wellness and Prevention of illness.  These two areas bearing in mind the associated enabling themes, particularly innovation and adoption, digital health, person centre care, clinical trials and evaluation and education skills, suggest that any one of several chronic conditions could be treated.  These would include, long term ulceration, muscle rehabilitation post operation and muscle rehabilitation in long term atrophy and COP for example
 
Prioritising depends on knowledge of clinicians who are interested in pilot application work of the therapy in their particular area of specialism.
Measures:
Depending on the application chosen we would expect to be able to show that through the application of NMES technology, faster healing or rehabilitation will take place.  This of itself will produce significant treatment cost reduction and in many cases will prevent escalation of the condition into subsequent stages which themselves require more intensive and expensive treatment.
 
In clinical trials generally of NMES devices in many applications over the last 20 years, there have been few if any safety issues arise or any adverse incidence reported so it can be confidently stated that the therapy is inherently safe. If the decision is use to apply the therapy in conjunction with the web-enabled “Virtual Clinic” proposed in the original paper, we are then able to implement an appropriate selection of Patient Reported Outcome measures, which allow us to track the patients experience with the therapy and record the results on whatever parameters clinicians have chosen. 
Adoption target:
It would be valuable to establish one adoption pilot in one of the applications where there is strong evidence of efficacy and to do this requires introductions to medical staff with the  appropriate level of interest and authority. Experience of  a first pilot would suggest adoption targets going forward. Minimum viability would be one unit.
Rejection Reason:
The investment committee decided not to invest.
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