How a compression wound care device treats venous leg ulcers

Ian Bolland spoke to Dr Andrew Cameron, co-founder and CEO of FeelTect, a connected health wound care start-up based in Galway. Its flagship product, Tight Alright, is a compression device that is used to treat venous leg ulcers (VLU).  

Give us some general background about FeelTect. How did it all start?

Its journey began in the BioInnovate Ireland programme based at NUI Galway in 2016/2017. It was during this that I spent two months of clinical immersion in the University Hospital Galway (UHG) and Mayo Clinic, Rochester, observing a wide range of cardiovascular procedures over multiple care settings. The thousands of observations that our team made were coalesced into hundreds of clinical needs, which were then filtered based on factors such as market size, burden of proof, clinical impact, IP landscape, and time to market.

While in the wound clinics of UHG and Mayo Clinic, we saw a large number of patients being treated for venous leg ulcers (VLUs), many of whom had travelled a long way for treatment and had been affected by their wounds for months, or even years. VLUs are chronic, often painful wounds that can occur when the valves in the veins of the leg begin to fail, leading to a pooling of blood and breakdown of tissue. Compression therapy can overcome the failure in the veins and restore correct blood flow to successfully treat VLUs, however if the compression is too loose it’s ineffective, and if it’s too tight it’s dangerous. Unfortunately, achieving a targeted pressure with existing compression products is extremely challenging, even for experienced healthcare professionals, and pressure can be rapidly lost over time with reductions in swelling, meaning that one in five VLUs don’t heal within a year.

After a number of discussions with Dr Georgina Gethin, head of nursing at NUI Galway, we identified a critical unmet need for developing a way to improve the application and maintenance of evidence-based pressure during compression therapy of venous leg ulcers, for improved healing outcomes and quality of life. To address this, an Enterprise Ireland Commercialisation Fund project was started in January 2018, within the labs of Prof. Garry Duffy, in the School of Medicine at NUI Galway. The successful outputs from this project saw the formation of FeelTect in May 2019, with founders including myself (CEO), Dr Darren Burke (CTO), and Prof. Garry Duffy (CSO). Tight Alright is a wearable device capable of measuring and monitoring sub-bandage pressure during compression therapy, primarily for people with VLUs.

What kind of technology has gone into the development of Tight Alright?

Figure 1. Schematic representation of Tight Alright technology and key features. It is comprised of a pressure sensing clip that measures, displays, and records data, which can be transmitted via Bluetooth to a mobile app.

Tight Alright is a reusable connected-health device that is unique in its handling and functionality compared with existing products, its design features have been tailored for ease of use by healthcare professional, carers, and patients alike. The wearable clip design has an inner arm housing the pressure sensing region comprising a force sensitive resistor (FSR) that is placed beneath the bandage, and an outer arm housing the electronics that remains outside the bandage and transmits wireless signals to a mobile app. Tight Alright’s benefits include:

  • Designed for accommodating different patient profiles and different bandage types, enabling easy integration into existing treatment pathways;
  • Provides continuous monitoring capabilities for recording pressure outside the clinical setting, important for assessing compliance and loss of efficacious compression
  • Material properties tuned to provide a balance between comfort/safety to the patient and necessary flexural rigidity for insertion
  • Low-profile design offers unobtrusive, accurate pressure measurement at any point on the leg
  • Hinge facilitates uninhibited and versatile placement with securement to the bandage
  • User interface can incorporate training, educational, and motivational material to enhance user engagement with compression therapy

Figure 2. Schematic representation of the functionality and wearability that the unique Tight Alright design facilitates during bandage application including placement, measurement, and securement.

What were the challenges of developing a device that could work in a clinical setting?

A key challenge for us was introducing a connected-health technology into an area that has been long established, i.e. compression therapy, but has seen little (if any) development in the way of digital technology innovations. To gain acceptance and improve the potential for adoption of our Tight Alright technology, we committed to working with and learning from end-users from the beginning. This has meant engaging with an international panel of nurses, doctors, and key opinion leaders to get a comprehensive understanding of the clinical pathway for VLU patients and the associated challenges. As part of FeelTect’s co-development strategy, we have an ongoing usability study, co-ordinated by Health Innovation Hub Ireland, with outpatient and community nurses in Galway to assess user experience and device performance. Results and feedback from this study will formulate design inputs for next iteration prototyping.

Other challenges are around data protection and integration into existing digital platforms. We see Tight Alright’s full potential coming to fruition as part of a wider network of complementary digital technologies (including electronic health records), but co-ordinating this network and being mindful of the data protection implications that are associated is a massive undertaking. To address these issues, we’re talking with strategic partners that have an interest in the digital wound care space, as well as industry experts who can help navigate regulatory hurdles. Similarly, reimbursement is another challenge for FeelTect, given our business model (associated with our technology’s connected-health capabilities) doesn’t easily fit within existing reimbursement frameworks. To address the path to reimbursement, we’re engaging with key stakeholders in the healthcare supply chain and looking at innovative and value-based reimbursement options that demonstrate the health-economic benefit of our technology.

Have there been clinical trials with the device?

Preliminary clinical validation has already been conducted in an end-user study at University Hospital Galway, with nurses in the outpatient wounds clinic assessing the device’s functionality and usability. During the application of different forms of compression products on healthy volunteers, Tight Alright enabled experienced nurses to achieve a clinically effective, targeted pressure range (35-45 mmHg) up to 6 times more often than unguided compression. It is predicted this significant improvement in the ability to achieve a targeted pressure range will translate to substantial improvements in the average healing rates of VLU patients, through the consistent implementation of gold-standard therapy. We are now working with our clinical collaborator, Prof. Mary-Paula Colgan, and her team at St James’s Hospital Dublin, begin assessing the potential for Tight Alright to improve the application of compression therapy on VLU patients.

What gap did you see in the health market for treatments of venous leg ulcers?

While there is consensus of international guidelines that optimal therapeutic levels of pressure range from 35-50 mmHg, the application of standardised pressure is rarely achieved in clinical practice. In a study of 1,338 healthcare providers with expertise in compression therapy, less than 13% were able to achieve a targeted pressure range upon applying a short-stretch compression bandage. Furthermore, professional experience may have limited bearing on adequate application of pressure, and training has a narrow scope for making improvements. In a study of 63 nurses, less than 10% were able to achieve an optimal pressure range, and even after six weeks of guided training, this only increased to a 32% success rate. Even if pressure is applied correctly, there is a high likelihood that efficacious levels will be lost before a scheduled follow-up. This is because standard bandages are known to drastically reduce in pressure as swelling subsides, some by as much as 50% in three days, potentially depriving the patient of effectual treatment until seen again by a healthcare provider up to a week later. This data suggests that it is not an issue of training or expertise, it’s a limitation in the tools that are available to provide consistent, gold-standard, evidence-based therapy.

Patient non-compliance is another issue that hampers compression therapy, ranging from 2% to 42% of patients in randomised controlled trials, or 9.7% to 80% in community studies. Also, compliance can have a dramatic impact on the healing rate of VLUs, with one previous study reporting a 78% healing rate in compliant patients versus 29% in non-compliant patients after six months. The basis for non-compliance is complex and patient-specific, but given the treatment of VLUs often occurs over multiple care settings, it can be difficult to even assess non-compliance within current clinical practices, let alone address the issue.

The vast majority of traditional compression products on the market provide no form of pressure indication. The few devices that enable some form of sub-bandage pressure measurement can be broadly divided into two categories:

  • Separate pressure sensors that are often comprised of thin, inflatable probes connected by tubes to pneumatic pressure sensors

The limitation with separate pressure sensors is the difficulty in correctly placing the sensor, which can impact accuracy, and the restriction on the region of measurement once the sensor has been placed because of difficulty in removing the sensor and repositioning within an applied bandage. Furthermore, many of these sensors are prohibitively expensive for clinical use.

  • Inbuilt tension indicators that are incorporated within the material of bandages, such as lines or shapes on compression products that change under tension

Inbuilt tension indicators can be restrictive in their region of measurement and are inaccurate under varying patient profiles.

How can things be further developed with the product?

The ultimate aim is to integrate within a digital wound care platform that encompasses multiple data on a patient, potentially opening opportunities for data-drive optimisation and individualisation of treatment regimens. In this way, Tight Alright also aligns with FeelTect’s ambition to develop strategic partnerships with other wound care companies that could benefit from Tight Alright’s digital capabilities, whilst in return providing access to their distribution channels, product development expertise, and clinical validation resources.

Are there other treatment areas to explore?

While VLUs are the initial target indication of the Tight Alright technology, there is significant potential for its use in lymphedema, where compression therapy is also part of the gold standard treatment. Lymphedema is a progressive chronic condition that causes tissue swelling due to malformation (primary lymphedema) or damage to the lymphatic drainage system (secondary lymphedema). Like the treatment of VLUs, it is important to apply a designated level of pressure when treating lymphedema with compression, depending on the severity of swelling or the phase of treatment (e.g. intensive versus maintenance).

Anything else to add?

FeelTect has received a lot of support along its journey and we are very grateful to the many people and organisations that have allowed us to progress so rapidly. I would like to especially thank BioInnovate Ireland, Enterprise Ireland, NUI Galway, EIT Health, Health Innovation Hub Ireland, CÚRAM, and NDRC. We’re currently in discussions with potential partners and we have launched a seed round for fundraising to support the progression of Tight Alright into clinical practice.

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