Web enabled home self-treatment of musculoskeletal conditions and wound healing using electrotherapy managed by a“Virtual Clinic (#2005)

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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)
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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 many chronic medical conditions involving muscles, circulation and joints using a unique muscle stimulator  is  safe, well tolerated,  effective,  inexpensive and supported by  high quality clinical evidence.
 
 
Overview of Innovation:
Neuromuscular Electronic Stimulation (NMES) therapy represents a unique treatment  modality  for  intensive “self care” of chronic conditions where  therapist  assisted   hospital or clinic  based  conventional treatment might be disruptive, prohibitively expensive and often ineffective. With 6 FDA indications this therapy is widely adopted in the USA.
 
Conditions suitable for  treatment  include Arthritis, rehabilitation after SCI, TKA, THA, Stroke and  others. Treatment of wounds, and avoidance of DVT using electrotherapy are both currently under review by the Cochrane Collaboration.Recent research has shown that Sarcopenia can be reversed with improvements  in ambulation and  balance which may enable and  prolong  self–sufficiency.
 
For optimum effectiveness home self- treatment  should  be well  supervised  and in order to enable supervision we can provide a web based “Virtual Clinic “. This establishes a  reassuring “circle of care” around the patient and allows  ongoing contact between clinicians and patients.
 
The Neurocare™NC2000  (FDA and CE certified)  intended  for this project is a safe, non-invasive Neuromuscular Electronic stimulator (NMES). Its unique electronic design allows high powered (for full muscle involvement) stimulation at very low current (for comfort and safety).
 
It differs significantly from conventional NMES systems in that it recruits both “active” and “inactive” or injured muscle fibres, strengthening and re-educating the muscle by simulating exercise using a higher maximum output (300volts+) whilst only producing less than 10 milliamps of current. Devices can be purchased or rented.
 
With minimum familiarisation patients can self-treat with the Neurocare™ NC2000  reducing the need for lengthy and costly stays in hospital or clinic. A therapy simple  to operate and well tolerated means that treatment episodes with the Neurocare™  2000 in the self-care setting can be more frequent and intensive thereby promoting faster relief from symptoms and  full recovery . 
A recent article on  treating diabetic ulceration and other complications of diabetic foot and a  list  of clinical evidence for NMES treatment for the above and many other  chronic conditions  is available on request from Neurocare Europe Limited.
 
Effective, low cost therapy, patient self-administered, allows intensive treatment at a time convenient to the patient and delivers major treatment cost reduction for HCAs and greatly improves HRQoL  for the patient.
 

 
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 / Education, training and future workforce / Wealth creation / Clinical trials and evidence / Digital health / Innovation and adoption / Person centred care
Benefit to NHS:
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Benefit to WM population:
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Current and planned activity: 
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What is the intellectual property status of your innovation?:
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Return on Investment (£ Value): 
N/A
Return on Investment (Timescale): 
N/A
Ease of scalability: 
N/A
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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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