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

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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':
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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