"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial comparing different ways of treating leg lymphoedema (ACE)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at 2 pumps that help to drain lymph fluid for people with leg swelling (lymphoedema). Doctors call the pumps compression devices.
More about this trial
Lymphoedema Therapists may treat lymphoedema with bandages or stockings that put pressure on the legs and help to stop fluid build up (compression bandages or stockings). They may also use gentle massage (manual lymphatic drainage). People can be taught how to continue these treatments at home. But it can take a long time and you may need treatment every day.
These treatments can help to reduce the swelling but will not cure it.
Compression pumps that you use at home aim to reduce the swelling for a longer period of time. This study will compare 2 different pumps. The people taking part continue to have their planned treatment for lymphoedema as well as using the pump.
The aim of the trial is to see which of the 2 pumps reduces swelling the most.
Who can enter
You can enter this trial if you
- Have leg swelling which has been diagnosed as lymphoedema (which is not relieved by changing the position of your leg) - your doctor will discuss this with you
- Are at least 18 years old
You cannot enter this trial if you
- Have been diagnosed with cancer in the last 3 months, or your cancer was diagnosed in the past but has come back in the last 3 months
- Have had surgery, chemotherapy or radiotherapy in the last 3 months
- Had your first treatment for lymphoedema less than 3 months ago
- Have had an
infectionthat needed treatment in the last 2 weeks
- Have had a blood clot in your lung (pulmonary embolism) in the last 6 months
- Have had a blood clot in your leg (deep vein thrombosis) in the last 6 months
- Are already taking part in a trial
- Have had inflammation of a vein (thrombophlebitis) in the last 2 months (your doctor can advise you about this)
- Have another serious medical condition that could affect you taking part in the trial
- Have a waist measurement of more than 167cm, a hip measurement of more than 195cm, a measurement around your thigh of more than 89cm, or around your ankle of more than 56cm
- Are pregnant
This is a randomised trial. It will recruit 262 people in the UK and the USA. The people taking part are put into 1 of 2 treatment groups by a computer. Neither you nor your therapist will be able to decide which group you are in.
People in both groups have the
Pump 1 is called a Flowtron Hydroven and works using an inflatable compression stocking on your leg that is inflated to help drain the lymph fluid.
Pump 2 is called a Flexitouch and works in a similar way to pump 1 but also helps drain fluid away from your tummy (abdomen) as well as your leg.
Treatment with either pump takes about an hour every day. You have the treatment for 6 months.
Even if the compression pump helps you, you may not be able to continue using it after the end of the trial. The study team will discuss this with you.
Before starting treatment, a member of the trial team will measure your legs and make sure you have a well fitting compression stocking or bandage. They will give you instructions about how to use the pump. You will keep a daily diary about using the pump and your other treatments.
When you start using the pump, you see the trial team after a week, one month, 2 months, 3 months and 6 months.
At each visit they will
- Measure both your legs
- Find out how you are coping with the pump
- Ask if you have any new health problems or have seen a doctor since your last visit
You will be asked to fill out a questionnaire before starting treatment, and after 3 and 6 months. The questionnaire will ask about how you have been feeling and how the swelling affects your day to day living. This is called a quality of life study.
Some people have an ultrasound scan and a local tissue water assessment at each visit. A tissue water assessment is like an ultrasound scan and is not painful. The study team will explain more about this test.
Side effects of compression treatment can include
- Pain in the toes, foot or lower leg
- Cool, numb, white toes
These are usually due to the stocking or bandage being too tight (too much compression). You will be able to contact the trial team if you are having problems with side effects.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Christine Moffatt
NIHR Clinical Research Network: Cancer
Tactile Systems Technology