Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

ADMSC-fib safety and efficacy in patients with chronico wounds

This research study is investigating a new treatment called ADMSC-fib for people who have chronic wounds. These are wounds that have been open and not healing for a long time. The study is currently in Phase II, which means it's an early-stage trial. Doctors involved want to find out if this new treatment is safe to use and if it can help wounds heal better than current methods. They are also looking to understand if it has any helpful effects. The study is open to adults aged 18 and over, and both men and women are invited to potentially participate. The goal is to discover new and better ways to treat stubborn wounds.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz

Enrolment target

Start

18 Oct 2024

chronic wounds

What is this study about?

This clinical trial is exploring a new treatment, referred to as ADMSC-fib, for people who have chronic wounds. A chronic wound is one that has not healed properly over a long period, even with standard care. These types of wounds can be very difficult to manage and can significantly impact a person's life.

The main purpose of this study is to see if ADMSC-fib is safe to use and if it can help these stubborn wounds heal. This is an early phase of research (Phase II), which means it's one of the first times this specific treatment is being tested in a larger group of patients. The researchers are trying to find out if it has a positive effect on wound healing and how it compares to existing treatments.

Finding new ways to treat chronic wounds is incredibly important. If successful, new treatments could offer hope and better outcomes for many people suffering from these challenging conditions, helping them to heal more quickly and improve their quality of life.

Key takeaways

This study tests a new treatment (ADMSC-fib) for long-lasting wounds.
It's an early-stage trial (Phase II) focusing on safety and effectiveness.
Adults aged 18 and over, both men and women, are invited to participate.
The goal is to find better ways to heal chronic wounds.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for volunteers who have chronic wounds, meaning wounds that haven't healed for a long time. To be considered, you must be at least 18 years old. There is no upper age limit, so older adults are also welcome to take part.

Both men and women are encouraged to find out more. The medical team will check other specific health details to make sure the study is a safe and suitable option for you. This will involve reviewing your medical history and current health status.

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 18 years old or older?
Do you have a wound that has not healed for a long time?
Are you able to attend regular appointments for the study?
Are you prepared to discuss your full medical history with the study team?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely have a series of visits to the clinic or hospital. During these visits, doctors and nurses would carefully check your wound, record its size and appearance, and monitor your general health. You would receive the ADMSC-fib treatment according to the study plan. They would also take blood samples and perform physical examinations to track your progress and check for any side effects. There would be a follow-up period to see how the wound heals after the treatment. The total duration of your participation would be explained in full by the study team, along with details about the number and length of visits.

Potential risks and benefits

While we hope this new treatment could help chronic wounds heal, there's no guarantee of benefit, and it's possible it may not work for everyone. As with any medical treatment, there could be potential side effects or risks, which the study team will explain in detail. You will be fully informed about all known and potential risks before deciding to participate. Remember, taking part in a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is a 'chronic wound'?

A chronic wound is a sore or injury on the skin that has not healed properly over several weeks or months, despite usual medical care.

What does Phase II mean?

Phase II is an early stage of clinical research where a new treatment is tested in a group of patients to see if it's safe and effective, and to find the best dose.

What is ADMSC-fib?

ADMSC-fib is the name of the new treatment being investigated in this study for chronic wounds. The study aims to learn more about it.

Will I get paid to participate?

This information isn't provided, but most clinical trials cover travel expenses. You should ask the study team about any costs or reimbursements.

Can I still take my regular medicines?

The study team will review all your current medications to ensure they don't interfere with the trial. You should always tell them about everything you are taking.