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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)
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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':
NATROX® Oxygen Wound Therapy is a medical device designed to heal complex non-healing wounds to improve healing outcomes and quality of life, optimise clinical and economic resources, and reduce diabetic foot related amputation rates.
Overview of Innovation:
NATROX® Oxygen Wound Therapy is a portable, lightweight and easy to use patient-friendly device, designed to topically deliver continuous pure humidified oxygen to the wound bed. The device was developed in order to help improve healing outcomes in wounds which traditionally remain static due to wound hypoxia (oxygen starvation), a common symptom of diabetic and vascular issues.

The NATROX® system is comprised of an Oxygen Generator, 2 rechargeable batteries and a single-use disposable Oxygen Delivery System.  The therapy is designed to be used 24/7 and as an adjunct to standard of care, such as absorbent wound dressings, with an average therapy length of 12 weeks. The product is supported by a growing portfolio of clinical evidence, including RCT-level data, which has demonstrated a significant increase in the healing rates of complex and non-healing wounds, compared to standard of care alone (90% healing with NATROX®  vs 30% for standard of care).
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 / Innovation and adoption / Person centred care
Benefit to NHS:
It has been shown that over £5.3bn is spent by the NHS each year on the management of 2.2m wounds. The management of non-healing wounds accounts for a significant amount of NHS resources (approx. £3.1bn per year) and is increasing due to an ageing population and higher rates of diabetes and diabetic foot ulceration.  NATROX® therapy is designed to positively impact healing rates and thereby optimise both clinical and economic resources used on non-healing wounds, in turn helping clinicians and financial decision-makers to access and treat a greater number of patients.

Furthermore, it is well documented that patient quality of life is negatively impacted by having a wound, and especially a non-healing wound, with increases in social isolation and depression across this patient population. NATROX® therapy focuses on healing wounds which are unable to heal with standard treatments alone, as these treatments are unable to address the underlying causes of non-healing wounds, such as oxygen starvation (hypoxia). The therapy system therefore focuses on providing pure humidified oxygen to hypoxic wounds, whilst being comfortable, quiet, lightweight and easy-to-use for the patient, allowing normal mobility without any negative impact from the device.
Initial Review Rating
5.00 (1 ratings)
Benefit to WM population:
Increases in diabetes rates across the UK has in turn led to an increase in prevalence rates for diabetic foot disease and associated ulcers.  Furthermore, latest health economic evidence (e.g. Guest et al 2015 & 2017) has shown that non-healing wounds account for approximnately 57% of wounds at any time are deemed non-healing, which has a direct impact clinically, financially and to the patient experience.  Both minor and major amputation rates are increasing as a result due to the complexity of many diabetic foot ulcers, which has a significant impact on the health and wellbeing of these patients, with increased patient mortality following amputations of around 50% within 2 years.

Like many areas, the West Midlands is experiencing increased amputation rates, as a result of rising diabetes and diabetic foot ulcer prevalence.  This has a significant impact on the local health economy in the West Midlands area, especially in higher population bases such as city areas and surrounds.  Therefore, the adoption of NATROX® therapy across the West Midlands area could have a significant effect on helping to reduce non-healing levels within the diabetic foot ulcer population, and therefore positively impact the well documented clinical and economic cost that the burden of non-healing wounds brings with it.  

A resulting increased resource utilisation would allow a wider focus on the growing population of diabetic foot ulcer patients, improving clinical and economic output across local vascular, podiatry and wound management services.   
Current and planned activity: 
Inotec AMD is currently engaged with a variety of clinicians and decision-makers across the UK.  There are a number of local product evaluations active or soon to start, which will aim to demonstrate product afficacy in order to facilitate adoption of the technology locally and nationally.  in addition, a large NHS funded UK-based RCT is underway, which is due to report later in 2018.

Furthermore, the product is being reviewed both clinically and evidentially on a national level in both Scotland and Wales, where we are about to start a national clinical evaluation in Wales across both Welsh Podiatry and Tissue Viability networks, whilst in Scotland NATROX® therapy is being formally assessed by Health Improvement Scotland and the Scottish Health Technologies Group, in order to gain an official recommendation. 
What is the intellectual property status of your innovation?:
The intellectual property surrounding NATROX® therapy is owned by Inotec AMD Ltd.
Return on Investment (£ Value): 
Very high
Return on Investment (Timescale): 
0-6 mon
Ease of scalability: 
Simple
Regional Scalability:
NATROX® Oxygen Wound Therapy is not yet adopted at scale within the UK, but is undergoing product evaluations with a view to contract listings and wider adoption.  A programme of marketing and events is planned to support the wider awareness and adoption of the technology.
Measures:
Further clinical efficacy demonstrated through local and national product evaluations, health efficiency data supported by the NATROX® Health Efficiency Model utilising local clinical data and outcomes, patient quality of life data from local and national product evaluations, and usability info from clinical usage.
Adoption target:
Availability of NATROX® Oxygen Wound Therapy on podiatry, vascular and tissue viability product formularies and listings in hospitals across WM region, for use on all clinically relevant non-healing and complex wounds. 
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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)
WMAHSN priorities and themes addressed: 
Long term conditions: a whole system, person-centred approach / Wellness and prevention of illness
Benefit to NHS:
The most comprehensive analysis to date concludes that the cost of diabetes to the NHS is £9.8bn in direct costs in 2010/11. Around 80% is spent on complications. (Hex et al. Estimating the current and future costs of Type 1 and Type 2 diabetes in the UK, including direct health costs and indirect societal and productivity costs. Diabetic Medicine (2012).  Available at: http://onlinelibrary.wiley.com/doi/10.1111/ j.1464-5491.2012.03698.x/abstract)
 
People with diabetes are more likely to be admitted to hospital than people without the condition. In 2009-10 there were 160,000 more admissions for people with diabetes than would be expected for people of the same age without the condition.
 
They have longer hospital stays and are more often admitted overnight for planned procedures that could be performed as day cases. There were:
  • 570,000 extra bed days for people with diabetes
  • 40,000 more overnight admissions that would be performed as day cases in people without diabetes.
 Annual inpatient care, to treat short and long term complications of diabetes, is estimated at between £1,800 and £2,500 per patient.  This compares with annual outpatient costs, which includes the cost of medications and monitoring supplies, estimated at between £300 and £370 per patient. (http://www.diabetes.co.uk/cost-of-diabetes.html)
 
The following annual costs result from diabetes (http://www.diabetes.co.uk/cost-of-diabetes.html):
  • Cost of absenteeism: £8.4 billion per year
  • Cost of early retirement: £6.9 billion per year
  • Cost of social benefits: £0.152 billion
 People with diabetes are at increased risk of peripheral arterial disease and neuropathy, as well as having a higher risk of developing infections and decreased ability to clear infections. Therefore, people with diabetes are prone to frequent and often severe foot problems and a relatively high risk of infection, gangrene and amputation.
 
In 2010 to 2011 the NHS spent an estimated £639 million to £662 million on diabetic foot care. (https://www.diabetes.org.uk/Documents/Diabetes%20UK%20Cost%20of%20Diabetes%20Report.pdf)
 
Early detection and effective management of diabetic foot ulcers can reduce complications including preventable amputations, improving patient outcomes and reducing cost to the NHS.
Initial Review Rating
5.00 (2 ratings)
Benefit to WM population:
Diabetes has huge implications for quality of life and life expectancy, with costs to the NHS and to the economy.
 
The West Midlands has a considerable healthcare problem due to diabetes. 8.1% of the West Midlands’ adult population has diabetes, higher than the English average, with the figure predicted to rise. 
 
There are 346,339 registered patients with diabetes out of a reported population of 4.76 million. The prevalence is therefore 7.28%, whilst nationally the England prevalence is high but only 6.37%. Of concern is the fact that the rate of increase in the prevalence of diabetes over the last 3 years was 34.9% higher than in England as a whole. (NHS England (West Midlands)  http://www.wmscnsenate.nhs.uk/files/7914/6169/3440/Diabetes_Service_Specification_Final_April16.pdf)
 
The FREMS Solution is an effective innovation against pain and functional recovery that can increase quality of life for patients and reduce the burden on health services, thus reducing cost to the NHS, and increasing economic productivity.
Current and planned activity: 
BHR is looking for the following with respect to their involvement with WMAHSN:

1.       Creating awareness of the FREMS system both within the west midlands and the wider NHS arena
2.       To help identify interested diabetes centres who can utilise the FREMs for their patients
3.       To provide a platform for application for grant funding for further research into the use of the FREMS Aptiva system  
4.       To support an application of an HTA assessment by NICE
5.       To provide support to BHR in gaining access to the health networks that have an interest in new and novel technologies
 
BHR is hoping to start an evaluation of the FREMS Aptiva at the Endocrinology and Diabetes Centre at the Birmingham Heartlands Hospital subject to committee approval to show the utility of the FREMS Aptiva system.
What is the intellectual property status of your innovation?:
The FREMS IP is covered by worldwide patent.
Return on Investment (£ Value): 
medium
Return on Investment (Timescale): 
3 years +
Ease of scalability: 
3
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.

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