This is our discussion with Liz Hawes which was recorded for the Solutions OP Clinical Trials podcast. You can listen to the original recording here. Please note that the interview below is adapted and not a transcript. This was done to improve readability.

Interviewer: Welcome to the latest episode of the podcast. In today’s episode, we’ll discuss wound care. My guest is Liz Hawes, a nurse and a specialist in wound care. She’s also the CEO of Clinical Research Solutions, a CRO offering services in that area. In addition, she’s on the advisory board of the Primary Care Research Alliance. She works with primary care physicians, so her experience is quite unique, having expertise in different areas. For those who do not know, primary care physicians are GPs, family doctors, and other healthcare professionals who work in primary care.

Welcome Liz to this episode and thank you for taking the time at this busy time of year. I will start with our first question. Tell me a bit about your team, the services you provide, and what you do in general.

Liz Hawes: Thanks for having me as a guest on your podcast today. As you said, we run a CRO. For those who don’t fully understand what that means, we provide trial management services from beginning to end. I’m a nurse by background, and we’re a clinician-led team, so the people who work with us are grounded in clinical research delivery. They’ve all had some sort of background in research delivery, which enables us to look at the studies from a pragmatic, patient- and healthcare pathway-focused point of view.

We also provide the usual CRO services for clinical research, but we also conduct smaller service evaluations, case study series, and work very closely with the Primary Care Research Alliance to do that.

Interviewer: That’s brilliant, Liz. I think it’s something very unique about the services you provide, because most CROs don’t necessarily work with patients. They’re more like mediators between the hospitals and the pharma companies. In your case, you’re directly involved with patients as well, so you have this specific experience with patients, which I think is really beneficial.

Do you see this as something different, as a positive thing, that you have experience working with the patients and not just being the middleman, if you want to put it that way?

Liz Hawes: Yeah, I really do. And I think that having done a lot of the research on the delivery side of things means that when it comes to designing studies and knowing whether they’re actually going to work.

When I was delivering clinical research, we could tell the clients and commercial companies had that input into their protocols. We would review them as they came in, and some of them you just thought would never work in the healthcare system. They wouldn’t work for patients, and they were too much of a burden for them. So it gives that pragmatic, patient-focused side of it.

I also love doing both, and I love still having a hand in delivery. I love seeing patients. It means I get to not only manage the research but also, on the other side, see the difference it’s actually making for patients.

And our Home Wound Care service means that we can deliver parts of what’s done through clinical research solutions. Because we’ve got CQC registration, we can do other clinical aspects of the CRO work that we do. We do clinical quality oversight, education and training for some of the nurses in wound care, and we have patient-nurse, clinician-focused work. We do PPI (patient involvement) groups. It gives us a broad ability, and we work closely with our clinicians as well, particularly through the Primary Care Research Alliance.

When we’re talking about studies, looking to develop them and how they’re going to be delivered in practice, we’re doing that alongside our patients, our clinicians, and the pathways. I think it really helps that you then get a study that is being delivered to patients.

That’s actually going to work really well. It’s got patient focus in mind, which can sometimes be lacking. Obviously, these innovations are all for patients, but without that input, that focus can get a bit lost. So, it really does help a lot, I think, with what we do.

Interviewer: Thank you, Liz. That’s brilliant! I think it’s a very good model that helps not just the industry but also the patients at the same time and provides good oversight of what’s happening.

But I want to discuss a little bit about wound care as a speciality, because I think it’s not always seen as a very promising field, even though it’s very important in healthcare. You know, we all talk about cancer and respiratory diseases, but wound care somehow falls through the cracks.

Liz Hawes: Absolutely. And it is so important. I mean, just for some statistics. There are around 3.8 million people in the UK with a wound, which is about 7% of the adult population. And the cost to the NHS is huge. It’s about 8 billion a year. It’s clear that it has a huge impact, as half of community nurses’ time is spent healing wounds. When it comes to the patients, it’s a massive problem.

My experience of seeing these patients who suffer from chronic wounds and leg ulcers has an enormous impact on their lives. It prevents them from doing the things they should be able to do. And that can, in turn, drive other chronic diseases as well, because they’re immobile, in pain, and may be taking pain medication that can cause falls, which puts more pressure on the NHS. They can break their hip. It’s a driver for many other things as well. And for some patients, it leaves them housebound. They can’t really leave the house.

It’s a huge factor and has a significant impact. When you really sit and talk to patients about it, you truly understand the impact it has on them and their families. It’s a big problem in the UK.

Interviewer: And if you think about it, it’s not just wounds caused by, I don’t know, some diseases or something but you have to think about wounds in terms of surgery. So basically, all the patients who have surgeries also have wounds that need to heal.

Not to mention that, from a global perspective, there are so many wars and so many people with wounds, so I think wound care should be a priority area where people and companies should invest.

What is the current situation with the available commercial products for wound care? Do you think they’re sufficient? Do you think there are any unmet needs?

Liz Hawes: I think the national wound care strategy and guidelines have been worked on over the last few years, and they really demonstrate that the wound care patients are receiving is good enough, but it could be better, and how that could be improved.

At the moment, wound care for patients is very localised. It depends on the practice or surgery they’re at and how they’re receiving that care. It might be community care, as to the care they receive.

And the wound care strategy really outlines the need for more evidence on wound healing rather than wound management. And it’s interesting because one of the biggest conferences is called the European Wound Management, and it should actually be healing, because I think the focus is shifting.

There is a delay in diagnosis for patients. Patients with chronic leg wounds may not realise they have a disease in their veins or arteries that’s going to cause them a problem. They cut their leg, and that develops into an ulcer. They just dress it themselves and deal with it at home. And there’s a lack of understanding and education. Globally, there’s an understanding of what a heart attack is, how to deal with it, what to do, and what the signs and symptoms are. But for chronic wounds, that’s not the case, so education is a big factor.

The care that’s received across the UK is so varied, and there are numerous reasons for that. But the focus is probably very much on innovations that manage wounds, such as different types of dressings.

They absolutely have a place, and they absolutely treat certain kinds of things, such as antimicrobial dressings for infections, that can have a positive impact on healing. But there are fewer innovations coming into the NHS for those other things, like devices that can make a difference, and other pharmaceuticals that can be impregnated into dressings to make a difference.

The problem is that non-healing wounds can cause infection, and that’s a broad problem of antibiotic use. Antibiotic resistance can lead to amputations, and it reduces people’s quality of life. You know, there needs to be more focus on the innovations that are going to make a big difference to wound healing, and that is where we’re starting to see more innovations coming through.

But it can be challenging within the NHS to bring those innovations in, for a variety of reasons. I would say there are also digital tools that could definitely be used, including the integration of digital documentation across different systems.

A patient with a wound is not just seen within a primary care practice, a GP practice or the community. They may also be seen in the hospital setting, potentially by the vascular team. That digital documentation doesn’t pass on with the patient, such as wound documentation. A lot of that is written documentation.

There are new digital platforms that can be used for photographing, measuring, and assessing wounds. They would be very useful for integrating those systems between primary and secondary care to make the patient pathway smoother and more beneficial for patients. I think digital innovations are coming forward, and those new devices that are improving wound healing. There’s definitely a place for them.

I have experience with a patient. We were looking at an electronic stimulating device, and the patient had had the wound for about 9 years, had a pain score of 9 out of 10, and was ready to have her leg amputated because she couldn’t cope with it anymore. It was so bad and was significantly impacting her life. We used this electrical stimulation device on her, and the wound healed within 12 weeks, and she had no pain. These are the sorts of innovations that really need to get into the NHS. But there are issues around that, and I can talk about them.

Interviewer: That’s truly amazing. Now, if you think about it, it’s a really amazing achievement. I’m sure that patient is very happy. It changed her life entirely.

Liz Hawes: Absolutely changed her life, and she kept her leg, but most importantly, that was the next step for her, which was just to go and say, take it off.

Interviewer: Yeah, can you imagine? That’s quite horrible. You can tell for sure from your example. We definitely need something that could help patients, particularly those with chronic wounds that don’t heal, unless something’s done specifically.

And what can we do to attract more research in wound care in the UK? Do you have any recommendations or thoughts on this?

Liz Hawes: It’s a really good question. I think there’s research in the UK that shows it has become a bit more of a problem. The speed of the process across the UK and the NHS, and the lack of capacity within the NHS to do research, are problems. The sorts of things we’re seeing are the National Institute of Health Research (NIHR) implementing grants to develop research services in primary care. They’re able to develop research centres, so they have the time and capacity to actually do research.

I think there’s a growing understanding of the importance of research and primary care. It hasn’t really been a key place for research, but it’s absolutely up and coming. And you know, we see that through our primary care research lives. There are so many GPs, nurses, and primary care physicians who want to do research and be actively involved, but they don’t necessarily have the resources, and it’s reasonably underfunded.

But that’s where the commercial side of it comes in. If they are getting an income to support the staff who need to deliver it, that makes a big difference. And it enables them to broaden their research services. So that’s really important. If that becomes a what came first, the chicken or the egg situation, the money to invest in it and therefore to broaden the ability to do it, or doing it, having the capacity to do it. So yeah, that’s a challenging one. But I think that is changing, and there’s definitely a bit more capacity.

I think collaboration is a key factor, and I mean collaboration among industry, clinicians, and you and the NHS. It’s essential to scale innovations and to do the research well. That collaboration has to happen, and it’s happening increasingly. I think that’s improving in the UK. Obviously, it’s difficult to attract that when the current situation is as it is.

When I say about speeding up the process, there are new guidelines that are going to be implemented on the combined review through the MHRA, Ethics Committees, and those timelines are being updated. And I think that will also have an impact because there will be more accountability for the timeliness of starting studies, starting commercial studies, and getting patients recruited. I think those timelines are already there, but this is putting a kind of highlight on them and saying that they’re currently not good enough and need to get better. And I think that will improve drawing commercial research into the UK as things speed up.

Interviewer: I have to say here on the timelines because I’ve been working on this long enough that back in the day, we were able to set up a clinical trial within 4 months. I mean, that was a very good performance for us to achieve.

And then things kind of slipped, especially during COVID. You know, things took a very long time, and now we’re trying to get back on track over these 4 months, but my personal view is that we can do better. The biggest problem is always the hospitals’ resources and internal processes. These are what are holding things back.

In terms of timelines, I think the regulators are doing quite well at the moment, so I don’t necessarily have any complaints about them, but I wish we could be a bit more organised in terms of hospitals and how things are managed internally.

Liz Hawes: Yeah. I think that comes down to the setup during the approval time. That’s what we do within the Primary Care Research Alliance. That’s what we do. If we know there’s a study going for approval, we will get that site ready and set it up, ready to go when it’s approved.

There needs to be more of a shift towards that because it’s difficult to see how that delay can happen time and time again. That’s a change in the processes and, I guess, the prioritising of when you start that planning and when you start that set-up within a clinical care setting.

It’s difficult with the timelines because I always think of the 4-hour rule in A&E and how it basically demoralised everybody, even though it didn’t mean they were more capable of getting patients through A&E any quicker. But it did lead to processes being put in place that sped those patients through A&E, and hopefully this will start to have the same impact and won’t just demoralise NHS services even further, because let’s face it, they are struggling and they are at capacity.

But I think going back to the NIHR grants and other resources that are becoming available to improve research will make a difference, because therapeutic areas will be funded to deliver these research services. And OK, you could say, well, how can they suddenly have more time? It’s not about that. It’s about being able to fund dedicated research staff for those roles and have a dedicated research facility, which means they’re not competing for clinic space.

But what I found and continue to find is that in the NHS there can be a lack of understanding of the importance and benefits of clinical research, not just for patients but for the hospital or the GP practice. At the end of the day, the NHS is an enormous business, and the commercial research that comes into it brings in income so that other services can be improved.

I think there needs to be more education for NHS services on why it’s important and how it’s important. I think that will drive it even further, but these things always take time.

Interviewer: I agree that we definitely need more education, and people need to understand a little bit more about research, not only as a source of income but also as a source of treatment options for patients. I think that’s a big thing, because you have a limited budget, and how much you can invest in new drugs is constrained. Clinical trials, in fact, give patients access to new drugs and devices that might otherwise take years to obtain. So, from that point of view, it’s also very critical that people understand the importance of research.

But going back to the wound care and treatment. How can digital health and remote monitoring improve the outcomes of wound care? Do you have any insights or anything you would like to share on this?

Liz Hawes: Yeah, so I recently gave a talk at the RCNi conference (organised by Royal College of Nursing). It was about the use of a digital tool for wound care assessment. We were talking to a group of nurses, mostly nurses, who were delivering wound care from different settings on a daily basis.

They all had different issues that could be easily resolved through some form of digital innovation, such as linking services. It would enable a smoother patient pathway. It would enable nurses to monitor a wound more carefully. We know that nurses don’t see the same patient time and time again these days. Not always, sometimes they do. But you don’t have your named nurse, you don’t have the nurse that you always see necessarily these days.

Without these digital abilities to document and photograph, it’s difficult for the nurses to see what happened before, how the wound is progressing, and what impact the treatment is having on the wound.

The nurses who were there were really excited to be able to potentially have these digital innovations, and we were looking with them at how they could be implemented into their practice. It’s not just digital assessment; it’s monitoring of patients in different areas, including wound care and compression bandaging. How are we monitoring compression? How are we ensuring that patients receive the gold-standard care at all times?

These are all things that digital innovations can make a big difference in integrating pathways. I think it’s a huge challenge. As we know, the NHS is a bit behind in becoming electronic. But those electronic patient records are now coming to the forefront, and there is more ability to integrate electronic documentation.

So, I think in wound care, it could have a massive impact. Anything that speeds things up and makes it more efficient gives patients ownership as well. So being able to monitor their own wounds and take ownership of their own care.

I’ve seen in studies we’ve done that when you give them the tools to do it and educate them about their wound care and why these different things they need to do are important, such as putting their legs up, immobilising, and all those sorts of things, they suddenly engage much better with it. They’re much more compliant with their care, which then improves their wound healing. So, there’s absolutely a basis for the digital world in wound care.

Interviewer: Maybe because they can see for themselves how the wound is changing, if they can document it and monitor it themselves, it will probably make a big difference, and it is also important for nurses, as I work on some surgical studies as well. You can see that they need pictures and everything to see how the wound is healing, and it is important for the team to know what’s happening.

Liz Hawes: Absolutely. And it needs to be a combination of things as well. So, it’s not just one innovation that’s going to rule the wound care world or that it’s going to make all the difference. But combined together, they do make a big difference. I mean, an example is when we were monitoring the compression pressure being delivered, and patients could see their own pressures. And they knew they needed to be kept at this particular optimum level for them. And they would have a look, even though we were not asking them to.

And these are people I never thought would be able to use an iPad, but then they start using it all the time, get quite excited about it, and can say the pressure has maybe gone up because they haven’t put my legs up today. And so, it will drive them to do the things they need to do because they can visually see the difference it’s making. And being able to monitor themselves, like what their wound looks like. When it can feel like very slow progress, wound healing is slow progress.

And when they can see the difference, when you show them a picture of what it looked like 3 weeks ago and what it looks like today, that’s really motivational for them to see. It’s also important to know if a treatment has been changed and it doesn’t suit them. They know that dressing isn’t very good for their legs. So that’s equally as important as well.

Interviewer: That’s amazing, thank you so much. That’s really interesting. It’s amazing to hear that it actually helps. Even people who are not that techy, as we like to call them, feel comfortable with this.

Liz Hawes: It’s amazing. I take on board that we have a bias in that. We really thought that, because a lot of the chronic leg wound patients have these wounds, they are an older population. And the reality is they’re not tech-savvy in general. If they’re in their 70s or 80s, some don’t even have the internet at home. I think that’s important for innovation as well; it has to be really user-friendly. And when they’re very intuitive, patients can use them.

You make them simple, and patients really enjoy it. Some are quite resistant to it, but if they try it, they find it better. We are treating this population now, but let’s face it: in 10 years’ time, our 60-year-olds are going to be 70, our 70-year-olds are going to be 80, and we will have more tech-savvy people using them, hopefully, more widely across the NHS, so that they become more widely available.

Interviewer: That sounds really positive. Thank you so much, Liz, for your time today and for talking about this with me.

It’s really interesting to learn about the importance of wound care, what’s available at the moment, and what the future holds. You gave us a very good overview of this, and I would like to thank you for your time and thank our listeners.