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Study on AUP1602-C for Treating Non-Healing Diabetic Foot Ulcers in Patients

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What is this study about?

This clinical trial is focused on studying the treatment of diabetic foot ulcers, which are wounds that occur on the feet of people with diabetes and can be difficult to heal. The treatment being tested is a new medication called AUP1602-C, which is applied directly to the skin as a cell suspension. This means it is a liquid containing cells that are placed on the ulcer to help it heal. The study will compare the effects of AUP1602-C with a placebo, which is a substance with no active medication, to see how well the treatment works and how safe it is for patients.

The purpose of the study is to evaluate the safety, tolerability, and effectiveness of AUP1602-C in treating non-healing neuro-ischemic diabetic foot ulcers. Neuro-ischemic refers to ulcers that are caused by nerve damage and poor blood flow, common complications of diabetes. Participants in the study will receive either the AUP1602-C treatment or a placebo, and the study will monitor how well the ulcers heal over time. The study will also look at how the treatment affects the overall health and quality of life of the participants.

During the study, participants will be randomly assigned to receive either the AUP1602-C treatment or a placebo. The study will be conducted over several weeks, with regular check-ups to assess the healing progress of the ulcers. The goal is to determine if AUP1602-C can help more patients achieve complete wound closure compared to those receiving the placebo. The study will also track any side effects or adverse events to ensure the treatment is safe for use. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

1 initial visit and screening

Upon joining the study, an initial visit is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

A blood test is performed to check glycosylated hemoglobin levels, which should be 11.0% or lower.

For women of childbearing potential, a pregnancy test is required to ensure a negative result before proceeding.

2 run-in period

A two-week run-in period is observed to assess the ulcer’s response to standard care. The ulcer should show a reduction in area of 20% or less during this time.

Patients are required to wear special footwear to reduce pressure on the ulcer while walking.

3 randomization and treatment start

After the run-in period, patients are randomly assigned to receive either the investigational product AUP1602-C or a placebo.

The treatment involves applying a cell suspension topically to the ulcer. The dosage is based on the size of the ulcer, specifically 2.5 x 10^8 CFU per square centimeter of ulcer size.

4 treatment phase

The treatment is administered according to one of two dosing schedules, which are determined during the study.

Regular follow-up visits are scheduled to monitor the ulcer’s healing progress and to check for any side effects.

5 evaluation and follow-up

The primary goal is to achieve complete wound closure within 20 weeks of starting the treatment.

Secondary evaluations include measuring the percentage of wound area reduction at various intervals: 4, 8, 12, 16, and 20 weeks.

Additional follow-up is conducted at 6 and 12 months after the last treatment to monitor for ulcer recurrence and other outcomes.

Who Can Join the Study?

  • Patients must be 18 years or older and in good physical and mental health to follow study procedures.
  • Women who can have children must use a highly effective birth control method during the study. Men who can father children must use at least two birth control methods, including a condom, during the study.
  • Patients must understand the study, agree to follow the procedures, and provide written consent to participate.
  • Patients must have type 1 or type 2 diabetes with a blood test called HbA1c showing a level of 11.0% or lower, which indicates blood sugar control.
  • Patients must have at least one diabetic foot ulcer that meets specific criteria, such as:
    • The ulcer has not healed by more than 20% during a 2-week period with standard care.
    • The ulcer has been present for at least 4 weeks but not more than 12 months.
    • The ulcer is located on the bottom or top of the foot, or at or below the ankle.
    • The ulcer can be fully covered by dressings and does not involve bone or joints.
    • The ulcer shows no signs of active infection or bone infection.
    • The ulcer size is between 1.0 and 10.0 cm² after cleaning.
    • The skin around the ulcer is suitable for applying a special film dressing.
  • If a patient has more than one ulcer, they can participate if the ulcers are at least 2.0 cm apart with healthy skin in between. The largest ulcer that meets the criteria will be treated.
  • Patients must have a blood flow test showing an ankle-brachial index (ABI) of 0.7 or higher, or a toe-brachial index (TBI) of 0.5 or higher, and a toe blood pressure of at least 50 mmHg (or ankle blood pressure of at least 70 mmHg if toe pressure is not measured).
  • Patients who have had a procedure to improve blood flow can participate 3 months after the procedure if their ulcer meets the criteria.
  • Patients must have an assessment of nerve damage in the lower limb where the ulcer is located.
  • Patients must agree to wear special footwear to reduce pressure on the foot while walking, as instructed by the study doctor.
  • Women who can have children must have a negative pregnancy test at the start of the study and before beginning treatment.

Who Cannot Join the Study?

  • Patients with any other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have allergies to any of the study medications or their ingredients.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients with poorly controlled diabetes, meaning their blood sugar levels are not stable.
  • Patients with active infections that require treatment with antibiotics.
  • Patients who have had a major surgery within the last 3 months.
  • Patients with a history of substance abuse or alcohol dependency.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients with impaired kidney or liver function that is not stable.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy

Other Sites

Site Name City Country Status
Med Polonia Sp. z o.o. Poznan Poland
Universita’ Di Pisa Pisa Italy
Azienda USL Toscana Sud Est Arezzo Italy
Diabetologische Schwerpunktpraxis Pirna Pirna Germany
Institut fuer Diabetesforschung Muenster GmbH Munster Germany
Ldpsrm Ctzwqwy Olpivf Nco Rgyqeb Wroclaw Poland
Pbhtw Ketqjpu Ljkpxgex Rpz Warsaw Poland
Mtheqgy Sdy z oqpq Lodz Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
01.04.2023
Italy Italy
Not recruiting
01.04.2023
Poland Poland
Not recruiting
01.04.2023

Trial locations

Investigated drugs:

AUP1602-C is a topical treatment being tested for its ability to help heal non-healing neuro-ischemic diabetic foot ulcers. This medication is applied directly to the ulcer and is being studied to see if it can safely and effectively close wounds that have not healed with other treatments. The trial is looking at how well this medication works when used in different treatment schedules, and it aims to find out if it can help more patients achieve complete wound closure.

Diabetic Foot Ulcers – Diabetic foot ulcers are open sores or wounds that occur on the feet of individuals with diabetes. They typically develop due to a combination of factors, including poor circulation, nerve damage, and high blood sugar levels. The progression of these ulcers can be slow, starting as a small sore and potentially expanding in size and depth. Over time, the ulcer may become infected, leading to further complications. The healing process can be prolonged, especially if blood sugar levels are not well-controlled. Regular monitoring and care are essential to manage the condition and prevent worsening.

Trial ID:
2022-502048-10-00
Protocol code:
AT-W-CLI-2022-04
Trial Phase:
Therapeutic exploratory (Phase II)

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