Study on the Safety and Effects of Udonitrectag for Treating Diabetic Foot Ulcers in Patients

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What is this study about?

This clinical trial is focused on studying a condition known as Diabetic Foot Ulcer, which is a common complication for people with diabetes. The study is testing a new treatment called Udonitrectag, also known by its code name MT8. Udonitrectag is a solution applied externally and is designed to mimic the effects of natural substances in the body called neurotrophins, which help in healing and tissue repair.

The purpose of the study is to determine how safe and tolerable Udonitrectag is when added to the usual care for diabetic foot ulcers, compared to the usual care alone. Participants in the study will receive either the standard treatment for diabetic foot ulcers or the standard treatment plus Udonitrectag. The study will monitor participants for any side effects, such as skin irritation or changes in blood and organ function, and will also measure how the body processes the treatment.

The study will last for several weeks, during which the healing progress of the ulcers will be closely observed. Researchers will look at how much the ulcer size reduces over time, aiming for a significant reduction in size. The goal is to see if adding Udonitrectag to the standard treatment can improve healing outcomes for people with diabetic foot ulcers.

1 joining the study

Upon joining the study, the patient provides a signed and dated informed consent form.

Females of childbearing potential undergo a urine pregnancy test to ensure a negative result before starting the study.

Patients must have glycated haemoglobin (HbA1c) levels of 10% or less.

Females of reproductive potential must use highly effective contraception for at least one month before the study and agree to continue during the study.

Males with partners of reproductive potential must use condoms or other effective contraception methods.

Patients must be willing to comply with all study procedures and be available for the study duration.

Eligible patients are those aged 18 years or older with a diagnosis of type 1 or type 2 diabetes mellitus and a diabetic foot wound grade I or II.

2 treatment phase

The treatment involves the application of Udonitrectag, a solution for external use, added to the standard care for diabetic foot ulcers.

The main objective is to determine the safety, tolerability, and pharmacokinetic profile of Udonitrectag compared to standard care alone.

The treatment duration is six weeks, during which the patient applies the solution as directed.

3 monitoring and evaluation

Throughout the study, the safety and tolerability of Udonitrectag are monitored by observing the nature, frequency, severity, and timing of any adverse events, including skin irritation and other laboratory results.

The primary endpoint is to assess the safety and tolerability of the treatment.

The secondary endpoint is to evaluate the efficacy by measuring the percentage of patients achieving at least a 50% reduction in ulcer area from baseline during the six-week treatment.

4 completion of the study

The study is estimated to end by March 31, 2025.

Upon completion, the data collected will be analyzed to determine the overall effectiveness and safety of Udonitrectag in treating diabetic foot ulcers.

Who Can Join the Study?

Provide a signed and dated form that shows you agree to participate in the study.
If you are a female who can have children, you must have a negative urine pregnancy test before starting the study.
Your HbA1c levels, which show your average blood sugar over the past 2-3 months, must be 10% or less.
If you are a female who can have children, you must use a very effective form of birth control for at least one month before the study and agree to continue using it during the study.
If you are a male with a partner who can have children, you must use condoms or other methods to ensure effective birth control with your partner.
You must be willing to follow all study procedures and be available for the entire duration of the study.
You can be either male or female.
You must be 18 years or older.
You must have been diagnosed with type 1 or type 2 diabetes.
You must have a diabetic foot wound that is classified as grade I or II according to the TEXAS diabetic wound classification system and grade 1 on the PEDIS infection scale.
Your TpO2 (a measure of oxygen in your tissues) must be 30 mmHg or higher, or your ABI (Ankle Brachial Index, a measure of blood flow in your legs) must be 0.70 or higher.
Your ulcer must not have healed with standard good care in the last two weeks, meaning the ulcer area has reduced by less than 20% compared to the start.
You must have an ulcer with an area between 2 to 15 cm², measured by a special device called the MolecuLight i:XTM Wound Imaging Device.

Who Cannot Join the Study?

Patients who have an active infection in the area of the ulcer cannot participate.
Patients with poor blood circulation in the legs, which can affect healing, are excluded.
Patients who have had recent surgery on the foot or leg are not eligible.
Patients with severe kidney disease, which affects how the body processes waste, cannot join the study.
Patients with liver disease, which affects how the body processes substances, are excluded.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are currently participating in another clinical trial are not eligible.
Patients with a history of allergic reactions to similar treatments are excluded.
Patients who have a condition that affects their immune system, which helps fight infections, cannot join the study.
Patients who are unable to follow the study procedures or attend scheduled visits are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Casa Di Cura Abano Terme Polispecialistica E Termale S.p.A. Con Sigla Casa Di Cura Abano Terme S.p.A.	Abano Terme	Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country	Status
Fondazione Luigi Maria Monti	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	01.07.2021

Trial locations

Investigated drugs:

UDONITRECTAG

Udonitrectag (MT8) is a new compound being tested for its potential to help treat diabetic foot ulcers. It is designed to mimic neurotrophins, which are proteins that support the growth and survival of nerve cells. In this trial, researchers are studying how safe and tolerable this compound is when added to the usual treatment for diabetic foot ulcers. They are also looking at how the body processes this compound.

Diabetic Foot Ulcer – A diabetic foot ulcer is an open sore or wound that occurs on the foot of a person with diabetes. It typically develops due to a combination of factors such as poor circulation, nerve damage, and high blood sugar levels. The ulcer often appears on the bottom of the foot and can be slow to heal. If not properly managed, it may become infected, leading to further complications. The progression of the ulcer can vary, with some healing quickly while others persist for longer periods. Regular monitoring and care are essential to prevent worsening of the condition.

Trial ID:

2024-519405-35-00

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on the Safety and Effects of Udonitrectag for Treating Diabetic Foot Ulcers in Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?