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

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Idea Description
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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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