Case Studies

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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.

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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.