Around 1 in 5 leprosy patients will experience a foot ulcer. Half of the in-patients in TLM’s hospitals are there for foot ulcer care. Sadly, even with good self-care, foot ulcers are still inevitable for many patients. Even worse, if you experience one foot ulcer, there is a good chance you will experience another because you are putting all your body’s weight on the good foot, thus making it prone to ulcers. The existing established treatments for foot ulcers are not adequate and alternatives must be proven to be effective.
Using Leprosy Research Initiative (LRI) funding, TLM Trust India are setting about proving that a common sense and cost-effective foot ulcer treatment could be around the corner. This would be big news for the millions of people who will experience foot ulcers in the years to come.
Put yourself into the shoes of a person who has an ulcer on their foot. You will have developed this ulcer because you did not receive your leprosy diagnosis and treatment in time to prevent nerve damage leading to loss of feeling in your foot.
Before this nerve damage happened, you would have noticed and felt pain if you were walking with a small stone in your shoe. You would have noticed if you had stepped on something sharp. You would have noticed if the ground you were walking on was too hot from the sun.
Now, because you couldn't feel the damage the stone in your shoe was causing on your long walk home from work, you have a bad wound on the sole of your foot. No amount of cleaning the wound and taking care of it seems to be helping it to heal. It doesn’t hurt, but you know it needs to be fixed or it could become infected and your leg may need amputating. So, you set out for the hospital.
The team at the hospital tell you that you need to keep pressure off the ulcer so that it can heal. You are lucky because you are at a hospital where there is someone skilled enough to put a plaster cast on your leg - a difficult task, apparently. The plaster cast has a small hole where the ulcer is, which allows you to change the dressing. The plaster cast allows you to walk without putting pressure on the ulcer, which in turn will allow the ulcer to heal. You have to keep this cast on your leg for at least four to six weeks, sometimes more. The cast can only come off by breaking it, so you can’t take it off at all in that time.
In most cases, ulcers that are managed with plaster casts are managed at hospital as in-patients and in some cases, the hospital sends you home and tells you to come back at the end of the six weeks, or when ulcer heals, to have the cast removed. This is when the real problems start. First, you discover that the cast is very itchy when you are travelling in the hot, humid air outside. When you get home, you realise that you cannot pull trousers over the top of the cast. You have to cut the leg off one of your few pairs. Then, you try to ignore the constant itch under the cast as you lie awake at night.
© Ruth Towell
The next morning you go to have a wash, but that proves very difficult with a cast covering one of your legs. You have no way to keep the cast dry through this process and you are very worried about dirty water getting caught inside the cast and causing an infection. After the stress of the wash, you go about your day, still trying to ignore the urge to itch. Around midday, the itching becomes much worse and you look down to find ants crawling on the floor by your feet. You are sure that some ants are now inside your cast, causing chaos.
The itching is unbearable and your fear of an infection inside the cast has just shot up. You have no way of putting a soothing ointment or antiseptic on. On day one of life with your new cast, you begin to wonder how you’ll get through the next six weeks.
The above is the current gold standard for treating foot ulcers.
Led by Mr Karthikeyan (Karthik), TLMTI will be using funding from the Leprosy Research Initiative to develop an alternative to treating foot ulcers with a plaster cast.
Karthik tells us, “The plaster cast treatment has been proven to be effective; keeping pressure off the ulcer does allow it to heal. The problem is that plaster casts are very impractical.
“First, you do need a skilled technician to apply the plaster cast. Even if you are lucky enough to have such a technician at your hospital, the patients will still encounter many problems with the cast. We have some patients return to us in tears, long before the ulcer heals. They beg us to take the cast off so they can have some relief.”
The problem with the plaster casts are significant for the patient, but there is an alternative available, as Karthik explains,
“Most of the problems with the cast happen because the cast cannot be removed. For some time, people have been exploring alternative casts that could be removed. This includes using a removable walker cast, the kind that is cheap and readily available and can even be bought on Amazon for around £25-35.
“However, we currently have no scientifically-proven evidence that this removable walker cast is as effective as the plaster cast. Until we prove that, we cannot make the, removable walker cast a standard part of ulcer treatment across the world.”
A patient can remove the walker cast to wash, to apply a soothing ointment, or to get rid of a pesky ant. They can also fit a pair of trousers over it. Like with the plaster cast, a rubber sole can be placed inside, with a part cut out, so the pressure will be kept off the ulcer to give it space to heal.
This should make the process far less upsetting for patients and will increase the likelihood that they will keep the cast on throughout the four-six week treatment period or until ulcer heals.
© Tom Bradley
Another advantage of the removable walker cast is the simplicity for the medical staff. The plaster cast requires a lot of skill to apply and not many people can do it. As well as this, the plaster can take as long as two or three days to set in the colder, winter seasons. Meanwhile, in humid countries, the cast is almost impossible to apply during the more humid months. The removable walker cast is far simpler for a healthcare worker to apply and can be used all year round.
“Our aim with this research project is not to prove that the plastic, removable walker cast is better at healing ulcers. Our aim is to prove that it is at least as good as the current gold standard, the plaster cast. This is known as a non-inferiority trial.
“The primary outcome we are looking at is the number of ulcers healed within a six-week period and the size of the ulcer area after that period. Is the ulcer reducing and how long did it take to heal? This is what will help us to prove that plastic casts work at least as well as plaster casts.
“The secondary outcomes for this project are what can separate the plastic cast from the plaster cast. Here we are looking at patient satisfaction. We want to know how independent patients are with the cast – can they dress, clean, walk, and take care of themselves? What is their quality of life?
“We will also follow up with patients over a six-month period to find out if they have experienced recurrences. We are hopeful that the removable walker cast will promote better healing, which will lead to a better scar that will help to prevent ulcers in the same place in the future.”
The trial is a randomised control trial, taking place at two of TLMTI’s hospitals. The team are hoping to recruit 150 patients to the trial, who will be split evenly between the test group and the control group. The control group will receive the plaster cast and the test group will receive the removable walker cast.
The team hope to start the project in April next year and they expect recruitment to take around 15 months. With the six-month follow-up period, this should mean that results will be ready for publication in about 24 months.
With a total budget of just 44,000 euros, this project is an excitingly cost-effective and common sense treatment. Not only is the research project cost-effective, the long-term treatment options will be, as well. When they are cleaned and sanitised properly, the very affordable plastic casts will also be reusable for different patients.
If this project is successful, it will provide a treatment that could significantly improve quality of life for patients, it will be effective at all times of the year, it will be cheap, it will be simple for clinicians, and it could prevent ulcer recurrence. It is a project that we can be very glad to see getting started.
© RuthTowell
Mr Karthikeyan Govindasamy (research Coordinator)
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