Case Studies

Otsuka Digital Medicine System Trial

A North East and North Cumbria Innovation Pathway Partnership Case Study

In late 2016 / early 2017 Otsuka Pharmaceutical Europe Ltd. (OPEL) conducted interest calls with the NIHR Clinical Research Network North East and North Cumbria (NIHR CRN NENC), Northumberland, Tyne and Wear NHS Foundation Trust (NTW) and MedConNecT North to explore the use of an innovative technology to assist in the management of serious mental illness, the Digital Medicine System.

The Digital Medicine System incorporates various devices: a pill with a sensor that activates upon contact with stomach fluid; a wearable non-mediated patient worn patch, that receives the signal from the ingestible sensor and is also able to record certain physiological data; and a smartphone app that allows individuals to review their medication ingestion and daily activity level, as well as enter their mood and rest. The data can also be linked, via web-based dashboards, to clinicians and relatives of the participant.

OPEL’s goal is that the Digital Medicine System supports clinical decision making with greater empowerment to all end users; clinicians, patients and care-givers, achieving better health through greater insight into an individual’s healthcare in different care settings. OPEL had been introduced to various NHS Trusts within the North East and North Cumbria region and after initial meetings they entered into an agreement with NTW to help shape and deliver a multi-centred, open-label, real-world study using Otsuka’s new Digital Medicine System.

The NTW team who assisted the study development was led by Dr Stuart Watson (Consultant Psychiatrist) and consisted of Anna Massey (Senior Clinical Studies Officer: Mental Health), Lyndsey Dixon (Research & Development Manager) alongside support from various members of the wider research teams within NTW as well as Patient and Public Involvement and
Engagement assistance from Tracy Scott of Newcastle Upon Tyne Hospitals NHS Foundation Trust (NuTH).

One of the main problems which OPEL are looking to solve with the Digital Medicine System is that although clinically
efficacious treatments exist, such treatments are not always being taken or not taken properly. This results in a cost to the NHS for medicines which are not being effective due to them not being taken as prescribed.

During the initial phase of the collaboration, Dr Watson and the wider team looked at the best way to use the Digital Medicine package within NTW to best meet the needs of NTW patients and clinicians.

Once this had been agreed upon in March 2017 there was a workshop, facilitated by Tracy Scott and Lyndsey Dixon, which
involved patients and the public giving input into the study design and the use of technology within the patient population. This has led to a robust protocol being developed for this study and ensured that the patient population have had a voice in
the process.

The aim of the study is to provide a solid evidence base for the Digital Medicine System to not only show that it works, but
also that the clinician and patient population will be comfortable in using this new technology to support recovery and disease stability. This trial will look at the acceptance and performance of the Digital Medicine System in adults with schizophrenia, schizoaffective disorder, or first episode psychosis over an 8 week period.

The study will be commercially sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), based in the United States, and highlights the outstanding collaborative work taking place across the North East and North Cumbria region. The work between NTW, NuTH, MedConNecT North and Otsuka (OPEL and OPDC) has led to a multi-centre study to help provide an evidence base for a cutting edge concept and product to ensure patients benefit from innovative support.

Dr. Nathan Cope, OPEL European lead for the project commented, “It has been extremely important to capture the thoughts and opinions of clinicians and service users who will ultimately benefit from the Digital Medicine System; having their robust input has led to a genuinely collaborative study design that highlights what is important to them as end-users to demonstrate value.”

A characterisation of biofilm load on a Camstent’s coated Foley catheter

A North East and North Cumbria Innovation Pathway Partnership Case Study

Camstent was introduced to MedConNecT North in August 2017, with the aim of providing good quality clinical data
surrounding their innovative catheter coating.

NICE reports that 6.4% of people admitted to hospital get an infection; it’s estimated that up to 38% of all Hospital Acquired Infections (HAIs) are caused by urinary catheters ( Camstent viewed coating catheters as a way of decreasing the catheter associated infections and developed an approved coating that resists bacterial attachment in laboratory tests. If this can be demonstrated in clinical settings, it may in turn lower the rate of catheter related HAIs.

The team identified Mr Prasad of The James Cook University Hospital as a potential lead due to the patient population being ideal for the pilot study. Initial conversations with Mr Prasad focused on the results from the lab trial, appropriate patient population for the research trial and how best to set up the pilot study while looking towards how the results may be used to progress onto a larger clinical trial with potential funding streams.

Camstent and Mr Prasad worked together to develop a robust protocol which would not only help to provide evidence on
the coated catheters but would also be fit to run within South Tees Hospital. South Tees Research and Development and the Clinical Research Network North East and North Cumbria also assisted in supporting the study team in the completion of the regulatory applications and supporting documents for the trial (patient information sheets and consent forms).

The discussions resulted in the Camstent Foley Catheter trial. This pilot study is currently in set up at James Cook University Hospital (South Tees Hospitals NHS Foundation Trust) and is looking to recruit 20 participants to trial the new catheter and send the results to Nottingham University Laboratories for review. The aim of the trial is to validate the claims that a bacteria resistant coating reduces HAIs and provides better outcomes when compared against standard of care catheters.

The Camstent Foley Catheter trial demonstrates collaborative working between The James Cook University Hospital,
MedConNecT North, the National Institute for Health Research Clinical Research Network North East and North Cumbria (NIHR CRN NENC) and Camstent in setting up a study to collect evidence for a new device to assist patients in receiving high quality care and address infection issues in the NHS.



Granulox and Cumbria Partnership logo

HAWS; Haemoglobin Application to Wounds Study, a single-centre, controlled, prospective randomized trial in diabetic foot ulcer patients

A North East and North Cumbria Innovation Pathway Partnership Case Study.

In early 2017 MedConNecT North introduced Infirst Healthcare, UK distributor of Granulox® haemoglobin spray, to various Trusts in the North East & North Cumbria. After initial discussions, Cumbria Partnerships NHS Foundation Trust and InFirst entered an agreement to develop a clinical trial aimed at treatment of diabetic foot ulcers (DFU) with Granulox. Within Cumbria Partnership, study development was led by Dr Stacey Fisher (GP with Special interest in Research) and Dr Leon Jonker (Science & Innovation Manager), with support from the wider research team and Trust’s West Cumbria podiatry team.

DFUs are a common complication of diabetes and they have significant cost implications; managing them costs the NHS £650 million per year (NHS Diabetes report). The healing rate of DFUs is poor and on average only 24% of wounds will heal after twelve weeks of treatment (Margolis, 1999). Furthermore, those with larger ulcers and co-morbidities respond poorly to standard treatment in the first four weeks – and they end up being at risk of long-term wounds with substantial loss of quality of life and potentially risk of amputation.

Granulox® is a novel spray containing purified haemoglobin for use on chronic wounds. This spray is an innovative class III medical device designed for the treatment of chronic wounds, such as venous leg ulcer, arterial leg ulcer, mixed leg ulcer, diabetic foot ulcers, burns, secondary healing of surgical wounds and pressure sores. Granulox® can also be used on sloughy and infected wounds.

Initial discussions were centred on the potential of Granulox® spray demonstrated in 2 randomised control trials in venous leg ulcers, multiple case series in wounds of mixed aetiology and retrospective studies to date, and how the NHS could help to design a prospective research trial in diabetic foot ulcer. The aim was to plan a methodologically sound study that will provide further evidence on the effectiveness of Granulox® spray for accelerated DFU wound healing. These discussions culminated in the Haemoglobin Application to Wounds Study (HAWS). This randomised trial is now ethics-approved and has enrolled its first patients; it assesses the effectiveness of the Granulox® spray at 12 weeks of treatment, compared to an equally large group of 20 patients who will receive standard of care treatment as usual. The hypothesis is that improved healing rates will help to close more wounds faster, improve the patient’s quality of life as well as decrease the burden on the NHS.

Although the HAWS study is led and delivered by Cumbria Partnership NHS staff, this was enabled by effective collaboration with Infirst Healthcare and MedConNecT North. This alliance is a fantastic example of joint working between the NHS in the North East & North Cumbria and a Medical Technology Partner to provide a robust study for evidence generation involving a cutting edge device.

You can download a PDF of this case study here.

Geko and SouthTeesFT_Logo

The GEKO Study

Service: SME Interaction

Innovation Pathway: MedConnect (LEAD); R&I JCUH Research: Comm NIHR Portfolio Research

NHS Organisations: South Tees NHS Foundation Trust SG: Injuries & Emergencies

Firstkind Medical developed the GEKO device, which when first brought to market was used in the prevention of DVT. Since then the company have developed the device for use in oedema associated with injury and surgery.

The team at Firstkind Medical were keen to evaluate the device’s effectiveness in reducing the swelling caused by ankle fractures, in order to allow surgeons to operate earlier, thus resulting in a shorter hospital stay for patients and savings to the NHS.

MedConNecT North put FirstKind Medical in touch with a trauma and orthopaedic consultant at James Cook University Hospital. The concept was reviewed and thorough feedback was provided to the company on how best to run the trial, factors to be considered, background information that was required, costs to be analysed etc.

The collaboration has resulted in an NIHR portfolio a pilot study, conducted at James Cook University Hospital, ran by Mr Paul Baker and his research team. The study will be used to inform the design of a full RCT to generate robust meaningful research to inform national  and international practice with widespread adoption of the device.

This was Mr Baker’s first commercial study and the team hit 100% RTT recruiting a total of 20/5 patients.

You can download a PDF of this case study here.

Older case studies


The ‘Tookie Vest for Renal’

A North East and North Cumbria Innovation Pathway Partnership Case Study.

In early 2016 MedConNectNorth introduced Tookie to Dr Saeed Ahmed, Consultant Nephrologist at City Hospitals Sunderland.
The meeting considered the potential of adapting the Tookie vest, originally designed to prevent inadvertent catheter fall out in paediatric oncology patients, for use in adult HaemoDialysis (HD) patients…

Click here to download this case study.