All studies
CompletedInterventional

Reducing the impact of diabetic foot ulcers on patients and the NHS

Foot ulcers are open sores that affect around one in four people with diabetes. Even after healing, these wounds often return. How we think and feel can affect how well we look after our feet. Researchers have created a support programme called 'REDUCE' to help keep ulcers away. In this study, participants are placed into one of two groups by chance. One group receives standard NHS care. The other group gets standard care plus eight one-hour sessions with a health professional (such as a diabetes nurse) and access to a helpful website. The study welcomes adults with diabetes whose foot sores have healed within the last few weeks. Taking part involves answering questions about health and wellbeing over 12 weeks. The results will help researchers design better care programmes across the NHS.

At a glance

Status
Completed
Sponsor
University Hospitals of Derby and Burton NHS Foundation Trust
Enrolment target
24
Start
24 May 2021
Estimated completion
03 Sep 2021

What is this study about?

Foot ulcers are deep sores that happen below the ankle and affect up to one in four people living with diabetes. Because diabetes can reduce blood flow and cause nerve damage, these wounds often take months to heal. Sadly, many people find that once an ulcer heals, another one develops within a year. Living with foot sores can be distressing and get in the way of daily life.

Doctors know that managing diabetes involves our thoughts, habits, and feelings, not just medicine. Researchers at the Universities of Nottingham and York have created a new support package called 'REDUCE'. It is designed to give people practical tips, encouragement, and emotional support so they can lower their chances of getting another foot sore.

This pilot trial is testing how well the REDUCE programme works in practice before a larger national trial begins. Half of the people taking part will test the new programme alongside their usual NHS foot care, while the other half will continue with their usual care alone. Learning from both groups will help doctors improve foot care services across the UK.

Key takeaways

  • Tests a new support programme called REDUCE to help prevent diabetic foot ulcers returning.
  • Open to adults with diabetes whose foot ulcers have fully healed for at least two weeks.
  • Half of participants receive standard care, while half also receive eight support sessions and website access.
  • Takes place over 12 weeks and involves completing short questionnaires and interviews.
  • Completely voluntary, with no new medicines and no impact on your standard NHS care.

Who may be eligible?

You may be able to take part if you are aged 18 or older and have diabetes. To join, you must have had a diabetic foot ulcer that has fully healed for at least two weeks, with no broken skin or weeping sores remaining. You must also have both lower legs (without a major amputation) and feel able to read and talk through the materials in English.

You cannot take part if you currently have an open foot ulcer, or if you have an active joint problem known as Charcot foot. People living with severe mental illnesses that make regular appointments difficult, or those already taking part in another wound-healing study, will also not be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I am aged 18 or over and have been diagnosed with diabetes.
  2. I recently had a diabetic foot ulcer that has been fully healed for at least two weeks.
  3. I currently do not have any open or weeping wounds on my feet.
  4. I have not had a major leg amputation.
  5. I can comfortably read, write, and speak in English.
  6. I am not currently taking part in another clinical trial for foot wound healing.
Answer every question to see your result.

What does participation involve?

Taking part lasts about 12 weeks. You will be placed into one of two groups by random choice, like flipping a coin. If you are in the usual care group, your foot care continues as normal, and you fill out health questionnaires at the start, at 6 weeks, and at 12 weeks. If you are in the REDUCE group, you will also attend eight one-hour sessions with a trained healthcare professional, use a dedicated support website, and take part in two short interviews to share your thoughts on the programme. There are no new drugs or invasive medical procedures involved.

Potential risks and benefits

Taking part may not help your feet directly, but your feedback will help researchers make the REDUCE programme as helpful as possible for others in the future. There are no known physical risks or side effects from taking part. The main commitment is your time for the sessions and questionnaires. If any questions or discussions feel upsetting, you can pause or stop at any point. You are free to leave the study at any time without giving a reason, and your regular NHS care will not be affected.

Locations (2)

  • Royal Derby Hospital
    Approximate
    Derby, England
  • Norfolk and Norwich University Hospital
    Approximate
    Colney, England

Common questions

Will my usual NHS diabetes treatment change?

No. You will continue to receive your normal clinic appointments and foot care as advised by your healthcare team.

Do I have to take any new medications?

No. This study tests a supportive talking and learning programme, not new drugs, creams, or surgical treatments.

Can I choose which group I am placed in?

No. A computer puts participants into groups at random to make sure the trial is fair and scientifically sound.

What happens if I get another foot ulcer during the study?

You should contact your local foot care team straight away, as you normally would. Your safety and health always come first.

What if I do not have regular internet access?

The team provides written handbooks as well as the website, but you can check with the study team whether the programme suits your setup.

How to find out more

Christina Sheehan

Always speak to your GP or specialist before deciding to take part in a study.

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