RecruitingNAINTERVENTIONAL

Early Percutaneous Transluminal Angioplasty in Diabetic Foot Syndrome (PTA-DFS)

This study is investigating the best timing for a common procedure called angioplasty in people with foot ulcers due to diabetes. Angioplasty helps open up blood vessels. Researchers want to see if having this procedure very soon (within 48 hours) after a problem is found helps foot ulcers heal better and prevents serious limb or heart problems compared to having it at a later, more routine time. They will carefully measure how much ulcers heal and track other health issues over 12 months. This research aims to understand if quicker treatment can significantly improve recovery for people with diabetic foot issues.

At a glance

Status

Recruiting

Phase

Sponsor

Heinrich-Heine University, Duesseldorf

Enrolment target

200

Start

01 Feb 2024

Estimated completion

01 Nov 2028

Diabetic Foot Diabetes Mellitus Peripheral Arterial Disease Diabetic Neuropathies Diabetic Retinopathy Anemia Ulcer Foot Ulcer Ischemic Diabetic Polyneuropathy

What is this study about?

This study is all about finding the best way to treat foot ulcers in people with diabetes. Diabetic foot ulcers can be very serious, often caused by problems with blood flow to the feet and nerve damage. One common treatment to improve blood flow is called angioplasty. This is a procedure where a tiny balloon is used to open up narrowed blood vessels in the legs.

Researchers want to see if having angioplasty very early – specifically within two days (48 hours) of discovering a significant blockage – leads to better healing of foot ulcers compared to having the procedure at a more routine, later time. They will carefully measure how much the ulcers heal using special cameras and also look at whether early treatment reduces risks of more serious problems, like limb amputations or heart issues, over the following year. They are also looking into how bacteria in the wound might affect healing and how angioplasty changes this.

The study is important because doctors don't currently know the exact best time to perform angioplasty for these ulcers. By comparing an "early" approach to the standard practice, this research hopes to provide clear answers that could improve how we care for people with diabetic foot ulcers, helping them heal faster and avoid serious complications.

Key takeaways

This study compares early angioplasty versus routine angioplasty for diabetic foot ulcers.
The main goal is to see if quicker treatment helps ulcers heal better.
Researchers will also track if early treatment reduces serious limb or heart events.
Participation involves random assignment to a treatment group and follow-up for 12 months.
The study aims to improve care for people with diabetes-related foot problems.

Who may be eligible?

To join this study, you need to be an adult over 18 with type 2 diabetes and a foot ulcer. Your diabetes should be reasonably controlled, and you must have a specific type of foot ulcer that isn't an emergency but is caused by poor blood circulation.

You won't be able to join if you have type 1 diabetes, a sudden severe blockage in your leg, or certain serious health conditions like specific kidney diseases, severe mental health issues, or cancer in the last five years. Pregnant or breastfeeding women also can't take part.

You also can't join if you're currently taking certain medications like those that affect your immune system, or if you've recently taken part in another drug trial or donated blood.

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.

Are you an adult aged 18 or over?
Do you have type 2 diabetes and a foot ulcer?
Is your HbA1c (a diabetes control measure) below 10%?
Have you recently used certain immune-affecting medications or participated in another drug trial? (If so, you might not be eligible)

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of two groups. One group will have the angioplasty procedure within 48 hours, and the other will have it at a standard, later date. The doctors and nurses looking after you will know which group you're in, but the people analysing the study results won't, to keep things fair.

Throughout the study, you'll have several check-ups. These will include a full health review at the start, and then follow-up appointments at 24 hours, and then 1, 2, 3, 6, and 12 months after your angioplasty. During these visits, doctors will closely check your foot ulcer healing using special cameras, look at your overall health, including kidney function, and might do scans like ultrasounds. The total duration of your active participation, including follow-up, will be 12 months after the procedure.

Potential risks and benefits

Participating in this study might offer the benefit of receiving your angioplasty quicker, which some researchers believe could improve healing of your foot ulcer. However, as with any medical procedure, there are potential risks associated with angioplasty, such as bleeding, infection, or damage to blood vessels, although these are generally low. We can't guarantee a specific outcome for your health. You'll always be monitored closely, and you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine
Verified postcode
Düsseldorf, Germany· Recruiting

Common questions

What is angioplasty?

Angioplasty is a procedure where a thin tube with a small balloon is used to open up narrowed or blocked blood vessels, improving blood flow.

Why are they studying diabetic foot ulcers?

Foot ulcers are a serious problem for people with diabetes, and improving how they heal can prevent severe complications like amputations.

Will I know if I get early or later treatment?

Yes, you and your doctors will know which treatment you receive. However, the data will be analysed carefully so the results are fair.

What does a 'randomised' study mean?

Being 'randomised' means you're put into one of the treatment groups by chance, like flipping a coin. This helps make the study fair.

How long will the study last for me?

If you join, the study will follow your progress for 12 months after your angioplasty procedure.

How to find out more

Hans Lucas Busch, MD

hanslucas.busch@med.uni-duesseldorf.de +49 (0)211 81 08753 Official trial record

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