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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Ruhr-Universität Bochum	Bochum	Germany
Praxis Dr. med. Abdou Zarzour	Halle (Saale)	Germany
Nemocnice Trebic příspěvková organizace	Jejkov	Czechia
Centrum Medyczne Ultramed	Cracow	Poland
Venasum s.r.o.	Trencin	Slovakia
Angiologická ambulancia	Dunajská Streda	Slovakia
Sahlgrenska University Hospital-Vaestra Goetalandsregionen	Gothenburg	Sweden
Medical University Of Vienna	Vienna	Austria
University Medicine Greifswald	Greifswald	Germany
Ctc Hodonín s.r.o.	Hodonin	Czechia
Rostock University Medical Center	Rostock	Germany
Sanare spol. s r.o.	Svidnik	Slovakia
CHU Grenoble Alpes	La Tronche	France
Azienda Unita’ Sanitaria Locale Toscana Sud Est – U.O.C Chirurgia Generale d‘Urgenza	Montepulciano	Italy

Other Sites

Site Name	City	Country
Klinikum Region Hannover GmbH	Hanover	Germany
SRH Wald-Klinikum Gera GmbH	Gera	Germany
HELIOS Klinikum Emil von Behring GmbH	Berlin	Germany
Fakultni Nemocnice Bulovka	Prague	Czechia
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis	La Rochelle	France
Clinicmed Daniluk Nowak Sp. k.	Bialystok	Poland
Derma-B Kft.	Debrecen	Hungary
BKS Research Kft.	Hatvan	Hungary
Cévní chirurgie UL s.r.o.	Usti Nad Labem	Czechia
Obudai Egeszseguegyi Centrum Kft.	Dunaújváros	Hungary
University Of Debrecen	Debrecen	Hungary
Clinexpert Kft.	Budapest	Hungary
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Semmelweis University	Budapest	Hungary
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Helios Universitaetsklinikum Wuppertal	Wuppertal	Germany
Markhot Ferenc Oktatokorhaz Es Rendelointezet	Eger	Hungary
Centre Hospitalier Universitaire De Nantes	Nantes	France
University Of Pecs	Pecs	Hungary
Centre Hospitalier Lyon Sud	Pierre Benite	France
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
Diabetes Exzellenz Zentrum DDG Ludwigshafen	Ludwigshafen Am Rhein	Germany
Kožní ambulance Fialová, s.r.o.	Prague	Czechia
Kfjbkwhyo Fkycjnhae Deelkgo Gyqx	Dresden	Germany
Ksyeeotn Bmebwpswbqctbcyfbyccsrel gyqkc	Bremerhaven	Germany
Sebsxgkmim scqazc	Třinec	Czechia
Psrgrnvzxhb Dl Mzbid Shpppr	Ivrea	Italy
Ajtw Czmqmtd Mmfccmaj sp z ocql	Lodz	Poland
Akljcwkrdebs sujdgd	Presov	Slovakia
Alzsabbqiyyo aprcrkawpy	Trnava	Slovakia
Mwd Pxpaj Dze Oolbtwctt Hnenx uuo Avhhukpkobunhxwmtfigt Gssc	Hanau	Germany
Mzmlqgc Szs z oles	Lodz	Poland
Pyuelbixs Bnzij Kufmyccmojp Sekuw	Wroclaw	Poland
Uecsvqicei Hoxphqpf Ceuuhbo	Cologne	Germany
Pngvb Krwdazt Lhnnhnlw Rup	Warsaw	Poland
Mmnihdd Uktagamfxt Oh Gubw	Graz	Austria
Uelbjtjmrrwainwdhjzqs Wclxfinrq Aya	Wuerzburg	Germany
Ufzwagcmpfwnpmnbzzlnn Eouqs Ahe	Essen	Germany
Ryejdbxoy Zsyvysfatc Sssatdkcp	Arnhem	The Netherlands
Aig do Fuldbpfdb Ckfnct uhjsfq cobmgsu	Frosinone	Italy

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.09.2024
Czechia	Not recruiting	01.09.2024
France	Not recruiting	01.09.2024
Germany	Not recruiting	01.09.2024
Hungary	Not recruiting	01.09.2024
Italy	Not recruiting	01.09.2024
Poland	Not recruiting	01.09.2024
Slovakia	Not recruiting	01.09.2024
Sweden	Not recruiting	01.09.2024
The Netherlands	Not recruiting	01.09.2024

Trial locations

Investigated drugs:

Allogeneic Skin-Derived Abcb5-Positive Dermal Mesenchymal Stromal Cells

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.

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 ID:

2024-512720-11-00

Protocol code:

allo-APZ2-CVU-III

NCT ID:

NCT06489028

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?