AuthorisedTherapeutic exploratory (Phase II)Interventional

(ESMERALD) A phase-2A, single-centre, prospective, uncontrolled, open label, single arm, exploratory clinical study to evaluate the safety and efficacy of cutaneous AUP1602-C with foam dressing as a treatment for non-healing neuroischemic diabetic foot ulcers

This research study, called ESMERALD, is testing a new treatment for diabetic foot ulcers that are not healing well. These ulcers are often complex, involving both nerve damage and poor blood circulation. The treatment involves a skin application called AUP1602-C, used together with a foam dressing. The main goals are to find out if this treatment is safe and how well it helps ulcers heal completely within 20 weeks. The study will also track any side effects and how long people stay on the treatment. This is an early-stage study, meaning researchers are cautiously exploring its potential.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Aurealis Oy

Enrolment target

Start

16 May 2025

Diabetic Foot Ulcer

What is this study about?

Diabetes can sometimes lead to serious complications, including problems with the feet. One common issue is diabetic foot ulcers – open sores that can be hard to heal. If these ulcers don't get better, they can lead to more serious health problems. This study is focusing on a particular type of diabetic foot ulcer, called 'neuroischemic' ulcers, which means they are affected by both nerve damage and poor blood flow.

Researchers are testing a new approach using a special skin application called AUP1602-C, which is applied directly to the wound, along with a foam dressing. The main purpose of this study is to see if this new treatment helps these difficult-to-heal ulcers close completely and how safe it is for people. They will also be tracking how quickly the ulcers heal and if any side effects occur.

This is a 'Phase 2A' study, which means it's an early step in testing a new treatment. It's an important stage for gathering initial information about how well a treatment works and its safety before it can be studied in larger groups of people. Participants will be closely monitored to understand the benefits and any potential downsides of this new treatment method.

Key takeaways

This study is testing a new skin treatment (AUP1602-C) for specific diabetic foot ulcers.
It aims to find out how safe and effective the treatment is for healing these wounds.
Participants will receive the new treatment and have their ulcer closely monitored for up to 20 weeks.
The study focuses on ulcers that have both nerve damage and poor blood flow.
This is an early-stage study to gather initial information about the treatment's potential.

Who may be eligible?

The study is looking for adults aged 18 and over, regardless of whether they are male or female. You would need to have a diabetic foot ulcer that has not healed for some time, and this ulcer should also be affected by both nerve and blood flow issues.

Since this is a specific type of ulcer being studied, the research team will need to check your medical history and current health carefully. They will confirm that your ulcer fits the specific criteria for the study.

There might be other health conditions or medications that would prevent someone from joining, so it's important for the study doctors to review everything in detail to ensure your safety and that the study results are clear.

Quick self-check

Are you 18 years old or older?
Do you have a diabetic foot ulcer?
Has your ulcer not healed for some time?
Has your doctor told you your ulcer has both nerve and blood flow issues?

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 would receive the AUP1602-C treatment applied to your diabetic foot ulcer, along with a foam dressing. You would have regular visits to the clinic over a period of 20 weeks. During these visits, doctors and nurses will carefully check your ulcer, measure its size, and assess how it's healing.

They will also ask about any changes in your health and check for any side effects from the treatment. The overall duration of your active participation, including treatments and assessments, would be up to 20 weeks. After this, there would be follow-up observations at 6 and 12 months to see if the ulcer returns.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new treatment that might help heal your chronic diabetic foot ulcer, which hasn't responded to standard care. However, like all medical treatments, there may be potential risks or side effects from AUP1602-C or the dressing. These could include local reactions at the wound site, or other body-wide effects. The research team will explain all known risks and closely monitor you throughout the study to quickly identify and manage any issues. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Italy

Common questions

What is a diabetic foot ulcer?

A diabetic foot ulcer is an open sore or wound on the foot, common in people with diabetes, which can be slow to heal.

What does 'neuroischemic' mean for an ulcer?

It means the ulcer is affected by both nerve damage (neuro-) and poor blood supply (ischemic), making it particularly challenging to heal.

What is AUP1602-C?

AUP1602-C is the name of the new treatment being tested in this study. It's applied to the skin and used with a foam dressing.

How long will the study treatment last?

The active treatment and measurement period for your ulcer will last up to 20 weeks. There will also be follow-up checks after that.

Will I know if the treatment is helping?

Yes, the study team will regularly measure your ulcer to see how it's progressing and will discuss this with you during your visits.