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Study on the Effectiveness of Allo-APZ2-CVU for Patients with Long-Term, Non-Healing Venous Leg Ulcers

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of chronic venous ulcers, which are long-lasting wounds on the legs that do not heal properly. The study will test a new treatment called allo-APZ2-CVU, which is a type of cell therapy made from special skin cells. These cells are known as allogeneic skin-derived ABCB5-positive dermal mesenchymal stromal cells. The treatment is applied directly to the skin in the form of a suspension, which is a liquid containing the cells.

The purpose of the study is to see how well this new treatment works in helping these difficult-to-heal wounds close completely and to ensure it is safe for patients. Participants in the study will receive either the new treatment or a placebo, which looks like the treatment but does not contain the active cells. The study will follow patients over a period of time to monitor the healing of their wounds and any side effects they might experience.

Throughout the study, the healing progress of the wounds will be checked regularly, and the overall quality of life of the participants will be assessed using questionnaires. The study aims to provide valuable information on whether this new cell therapy can be an effective and safe option for people suffering from chronic venous ulcers.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The trial begins with an initial assessment to confirm eligibility. This includes a review of medical history and a physical examination.

    A pregnancy test is conducted for women of childbearing potential. Consent forms are signed after understanding the study details.

  2. Step 2

    Baseline visit

    During the baseline visit, the size of the chronic venous ulcer is measured using standardized photography.

    The target ulcer is identified if there are multiple ulcers, ensuring it is separated by at least 1 cm of healthy skin.

  3. Step 3

    Treatment administration

    The treatment involves the application of a cutaneous suspension containing allo-APZ2-CVU or a placebo directly onto the ulcer.

    The application is performed according to the study schedule, with the aim of promoting wound healing.

  4. Step 4

    Follow-up visits

    Regular follow-up visits are scheduled to monitor the progress of wound healing and assess any side effects.

    During these visits, the size and quality of the wound are evaluated, and questionnaires are completed to assess quality of life and pain levels.

  5. Step 5

    Primary endpoint evaluation

    The primary endpoint is assessed at Week 18, focusing on complete wound closure that has persisted for at least two weeks.

    Safety is also evaluated by monitoring any adverse events throughout the trial.

  6. Step 6

    Secondary endpoint evaluation

    Secondary endpoints include assessments of wound closure at each follow-up visit, changes in wound size, and quality of life evaluations.

    Additional assessments include pain levels, duration of wound closure, and any recurrence of the wound.

  7. Step 7

    Final assessment

    A final assessment is conducted to evaluate the overall outcomes of the treatment, including physical examination and vital signs.

    The study concludes with an assessment of immunogenicity to ensure the treatment's safety.

Who can join the trial?

8 criteria

  • Patients must be at least 18 years old.
  • Have a chronic venous leg ulcer on the lower leg or ankle that has not been there for more than 15 years. This condition should be diagnosed using special tests like Doppler or Duplex sonography, which are imaging tests to check blood flow, and an ankle brachial index (ABI) between 0.9 and 1.3. If ABI is more than 1.3 or cannot be measured, a toe brachial index (TBI) of at least 0.7 is needed. A physical and skin examination is also required.
  • The wound size should be between 1 and 25 square centimeters, measured by a standardized photo.
  • If there are two or more ulcers on the same limb, the main ulcer should be at least 1 cm away from other ulcers, with healthy skin in between.
  • Body mass index (BMI) should be between 15 and 50 kg/m². BMI is a measure of body fat based on height and weight.
  • Patients must be able to understand the study and provide written consent before any trial procedures.
  • Women who can have children must have a negative urine pregnancy test at the first visit.
  • During the trial, women who can have children and their male partners must agree to use highly effective birth control methods.

Who cannot join the trial?

10 criteria

  • Patients who have any other type of wound or ulcer that is not a chronic venous ulcer (CVU). A CVU is a long-lasting sore on the leg caused by poor blood flow in the veins.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who have a medical condition that could interfere with the study or make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have a known allergy to any of the substances used in the study treatment.
  • Patients who have a history of drug or alcohol abuse that could affect their ability to participate in the study.
  • Patients who have a mental health condition that could interfere with their ability to participate in the study.
  • Patients who have a serious illness that could affect their participation in the study.
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Investigated drugs

allo-APZ2-CVU is a treatment being tested for its ability to help heal chronic venous ulcers that have not responded to other therapies. It is applied directly to the wound to see if it can promote complete wound closure and improve healing. The trial is also checking if this treatment is safe for patients to use.

What is already known about the treatment

Allo-APZ2-CVU – This medication is administered topically, meaning it is applied directly to the skin on the target wounds. It is currently being studied in a Phase III clinical trial to assess its effectiveness and safety for treating chronic venous ulcers that do not heal with standard therapies. The main therapeutic indication is for chronic venous ulcers, which are long-lasting wounds on the legs due to poor blood circulation. The mechanism of action involves promoting wound healing at the molecular level, although specific details are still under investigation. Allo-APZ2-CVU is classified pharmacologically as a regenerative medicine product, focusing on enhancing the body's natural healing processes.

Investigated diseases

Chronic Venous Ulcers – Chronic venous ulcers are open sores that occur on the skin, usually on the lower legs, due to poor blood circulation in the veins. They develop when the veins in the legs do not efficiently return blood back to the heart, leading to increased pressure and fluid buildup. This pressure can cause the skin to break down, forming an ulcer. These ulcers are often slow to heal and can persist for weeks or even longer. They may become larger over time if not properly managed. Symptoms can include swelling, aching, and changes in skin color around the affected area.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512720-11-00Protocol codeallo-APZ2-CVU-IIIEstimated enrolment172 patientsSponsorRheacell GmbH & Co. KG

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).