RecruitingNAINTERVENTIONAL

Diabetic Foot Ulcer Research Study

This research study is looking into a new type of wound dressing for people with diabetic foot ulcers. We want to find out if this new dressing works better and is as safe as the current dressings used in the NHS. If you take part, you'll continue attending your usual NHS podiatry clinic appointments. At random, you'll receive either the new study dressing or the standard NHS dressing. Researchers will then carefully compare how well wounds heal in both groups over 12 weeks. The main goals are to see if the new dressing leads to complete wound healing and a bigger reduction in wound size. This study aims to improve care for diabetic foot ulcers.

At a glance

Status

Recruiting

Phase

Sponsor

Community Pharmacology Services Ltd

Enrolment target

100

Start

26 Apr 2024

Estimated completion

01 Jan 2027

Diabetic Foot Ulcer Diabetic Foot Ulcer Neuropathic Diabetic Foot Ulcer Ischemic

What is this study about?

If you have a diabetic foot ulcer, you might be interested in this research study. We are looking at a new type of wound dressing to see if it can help speed up healing and is as safe as the current treatments offered by the NHS. Diabetic foot ulcers can be a serious complication of diabetes, so finding effective ways to treat them is very important.

This study will involve people attending their regular foot clinic appointments within NHS Lanarkshire. During these appointments, some participants will receive the new dressing, while others will get the standard dressing that the NHS currently uses. Neither you nor your healthcare team will choose which dressing you receive – it will be decided by chance.

The main aim is to see if wounds heal completely within 12 weeks with the new dressing and if the wound size shrinks more. By carefully comparing the two groups, we hope to learn whether this new dressing could be a good option for future care for people with diabetic foot ulcers.

Key takeaways

Compares a new dressing for diabetic foot ulcers to standard NHS care.
Aims to see if the new dressing helps wounds heal faster and better.
Participate by continuing your regular NHS foot clinic appointments.
Study lasts for 12 weeks.
Your care will not be affected if you choose not to join or decide to leave.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with either type 1 or type 2 diabetes. You must also have a new diabetic foot ulcer that is not infected and is between 10 square millimetres and 100 square millimetres in size. The ulcer could be caused by nerve damage (neuropathic), poor blood flow (ischemic), or a combination of both.

It's important that you can understand and follow instructions given in English, both spoken and written. You also need to be able to give your informed consent, which means you understand what the study involves and agree to take part, including allowing medical photographs of your wound.

However, you can't join if you have a known allergy to any of the ingredients in the new dressing, or if you're pregnant or breastfeeding. If you're a woman who could become pregnant, you'll need to be using reliable contraception. You also can't take part if there's a suspicion of cancer in your wound, if you have severe blood flow problems in your leg (critical limb ischemia), or if you might have difficulty following the study's instructions, especially regarding special footwear to relieve pressure on your foot.

Quick self-check

Are you 18 years or older?
Do you have type 1 or type 2 diabetes?
Do you have a diabetic foot ulcer that is not infected?
Can you understand and follow instructions in English?
Are you able to use special footwear daily, if needed?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll continue to attend your usual NHS podiatry clinic appointments. During these appointments, your foot ulcer will be treated with either the new study dressing or the standard NHS dressing. The healthcare team will tell you which one you receive. You'll need to wear special footwear (an 'offloading system') as part of your standard care, and it's important to use it daily as advised.

During your appointments, researchers will regularly check your wound, measure its size, and take medical photographs to track its healing. These assessments will happen over a period of 12 weeks. After 12 weeks, the main part of your participation in the study will conclude.

Potential risks and benefits

Taking part in this study might offer the benefit of potentially receiving a new dressing that could help your wound heal more effectively than standard care, though this is not guaranteed. However, there's also a possibility that the new dressing might not work as well, or you could experience an allergic reaction if you have an unknown sensitivity to its ingredients. Like any medical procedure, there's a small risk of discomfort or complications related to wound care. You will always have the right to withdraw from the study at any time, for any reason, without it affecting your usual NHS care.

Locations (2)

NHS Lanarkshire
Airdrie, United Kingdom· Recruiting
NHS Lothian
Livingston, United Kingdom· Recruiting

Common questions

What is a diabetic foot ulcer?

It's an open sore or wound on the foot that can occur in people with diabetes, usually because of nerve damage or poor blood circulation.

Will I know which dressing I'm getting?

Yes, your healthcare team will tell you whether you're receiving the new study dressing or the standard NHS dressing.

How often will I need to go to the clinic?

You'll attend your usual NHS podiatry clinic appointments as you normally would for your treatment.

What if I change my mind about taking part?

You can withdraw from the study at any time without giving a reason, and it won't affect your regular NHS care.

What is 'offloading'?

It's a way to take pressure off your foot ulcer, often using special footwear, to help it heal. You'll need to wear this as advised.

How to find out more

Duncan Stang, MChS

duncan.stang@lanarkshire.scot.nhs.uk 07554333493 Official trial record

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