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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 a condition known as Diabetic Foot Ulcer, which is a common complication for people with diabetes. The study is testing a new treatment called AUP1602-C, which is applied directly to the skin as a cell suspension. This treatment is being used alongside a foam dressing to help heal foot ulcers that are not improving with standard care.

The purpose of the study is to evaluate how safe and effective AUP1602-C is in helping these ulcers heal completely. Participants in the study will receive the treatment and be monitored over a period of up to 20 weeks. The study will look at how many patients achieve complete healing of their ulcers and will also monitor for any side effects from the treatment.

Throughout the study, participants will have regular check-ups to assess the progress of their ulcer healing and to ensure their overall safety. The study aims to provide valuable information on whether AUP1602-C can be a beneficial treatment option for those suffering from non-healing diabetic foot ulcers.

1 beginning of treatment

Upon joining the study, you will begin treatment with a cell suspension called aup1602-c. This is applied directly to the skin on your diabetic foot ulcer.

The treatment involves applying the cell suspension to the ulcer, followed by covering it with a foam dressing. This is done to help the ulcer heal.

2 treatment schedule

The treatment with aup1602-c will continue for up to 20 weeks. During this time, the application of the cell suspension and foam dressing will be repeated as instructed by the study team.

You will be monitored regularly to assess the healing progress of your ulcer.

3 monitoring and assessments

Throughout the study, your ulcer will be checked at specific intervals to see how well it is healing. This includes measuring the size of the ulcer and checking for any signs of infection.

You will also be asked about any changes in pain levels and any other symptoms you may experience.

4 safety and tolerability checks

The study will include regular checks to ensure the treatment is safe and well-tolerated. This involves monitoring for any side effects or adverse reactions to the treatment.

You will be asked to report any new symptoms or changes in your health during the study.

5 completion of treatment

At the end of the 20-week treatment period, a final assessment will be conducted to evaluate the healing of your ulcer.

You may be asked to return for follow-up visits to monitor the long-term effects of the treatment and check for any recurrence of the ulcer.

Who Can Join the Study?

  • Patients must be 18 years or older.
  • Women who can have children must agree to use a highly effective birth control method during the study. Men who can father children must use at least two forms of birth control, including a condom, during the study.
  • Patients must understand the study procedures and agree to follow them, providing written consent before joining the study.
  • Patients must have Type 1 or Type 2 Diabetes with a blood test result called HbA1c of 11.0% or less, which shows their average blood sugar level over the past 3 months.
  • Patients must have at least one Diabetic Foot Ulcer (DFU) that meets all of the following conditions:
    • The ulcer has not healed by more than 20% after 2 weeks of standard care.
    • The ulcer has been present for at least 3 months 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 treated with the study medication and covered with dressings.
    • The ulcer is full-thickness, meaning it 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 ulcer and surrounding skin are suitable for foam dressings.
    • The ulcer size can be accurately measured to track healing progress.
  • 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 result called ABI of 0.7 or higher, or a TBI of 0.5 or higher, and a toe blood pressure of at least 50 mmHg, or an 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 join the study 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 time of screening and again before starting treatment.

Who Cannot Join the Study?

  • Patients with a Diabetic Foot Ulcer that is not healing.
  • Patients with a neuroischaemic condition, which means there is nerve damage and poor blood supply to the area.
  • Patients who do not meet the specific inclusion criteria for the study.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Universita’ Di Pisa Pisa Italy

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

Trial status

Country Status Recruitment Start
Italy Italy
Not yet recruiting
15.04.2025

Trial locations

Investigated drugs:

AUP1602-C is a treatment being tested for its ability to help heal non-healing diabetic foot ulcers. These ulcers are a common problem for people with diabetes, especially when there is poor blood flow to the area. The treatment involves applying AUP1602-C directly to the skin where the ulcer is located. The goal is to see if this treatment can help close the wound completely within 20 weeks. The study also looks at how safe and tolerable the treatment is for patients, meaning they want to make sure it doesn’t cause any harmful side effects.

Diabetic Foot Ulcer – Diabetic Foot Ulcer is a common complication of diabetes mellitus, characterized by an open sore or wound that occurs on the foot. It typically develops due to a combination of factors, including poor circulation and nerve damage, which are common in individuals with diabetes. The ulcer often starts as a small sore or blister and can progress to a larger, deeper wound if not properly managed. Over time, the ulcer may become infected, leading to further complications. The healing process is usually slow, and the ulcer can persist for weeks or months. Proper foot care and monitoring are essential to prevent the progression of the ulcer.

Trial ID:
2024-519317-66-00
Protocol code:
AT-W-CLI-2024-10
Trial Phase:
Therapeutic exploratory (Phase II)

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