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Study on the Effectiveness and Safety of allo-APZ2-CVU for Healing Chronic Venous Ulcers in Patients with Therapy-Resistant Wounds

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for chronic venous ulcers (CVU), which are long-lasting wounds that occur due to poor blood circulation in the veins of the legs. The treatment being tested is called allo-APZ2-CVU, a type of cell therapy that uses special cells derived from skin to help heal these stubborn wounds. The study will compare the effects of three different doses of this treatment to a placebo to see how well it helps in closing the wounds and ensuring safety for the patients.

The main goal of the study is to observe how effectively the treatment can close the wounds and to monitor any side effects that may occur. Participants will receive the treatment applied directly to their wounds. The study will take place over several weeks, with regular follow-up visits to check on the progress of wound healing and to assess any changes in the size of the wound, the time it takes to heal, and the quality of healing. The study will also evaluate the impact of the treatment on the participants’ quality of life and any pain they experience.

By participating in this study, researchers aim to gather valuable information on the potential benefits and safety of allo-APZ2-CVU for individuals suffering from chronic venous ulcers. This could lead to new treatment options for those who have not responded to existing therapies. The study is designed to ensure that all participants are closely monitored throughout the process to ensure their well-being and to collect accurate data on the treatment’s effectiveness.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, presence of a chronic venous ulcer, and other health parameters.

Written informed consent is required before any trial procedures begin.

2 initial assessment

An initial assessment is conducted to evaluate the size and condition of the target ulcer using standardized photography.

A blood pregnancy test is performed for women of childbearing potential.

3 treatment administration

The investigational medicinal product, allo-APZ2-CVU, is administered topically on the target wound.

The treatment involves a cutaneous suspension applied directly to the skin.

4 follow-up visits

Regular follow-up visits are scheduled to monitor wound healing progress and any adverse events.

Wound size changes are assessed at each visit, and complete wound closure is evaluated.

5 quality of life and pain assessment

Quality of life is assessed using the Wound-Quality of Life Questionnaire at specific visits.

Pain levels are measured using a numerical rating scale during follow-up visits.

6 final evaluation

The primary endpoint is complete wound closure at Week 18, persisting for at least two weeks.

Secondary endpoints include the duration of wound closure, recurrence, and overall quality of wound healing.

Who Can Join the Study?

  • Male or female patients who are at least 18 years old.
  • Have a chronic venous leg ulcer, which is a sore on the leg that doesn’t heal within 3 months despite treatment or hasn’t fully healed within 12 months. It should be located on the lower leg or ankle and not have been present for more than 15 years. This condition is diagnosed using tests like Doppler or duplex sonography (which are imaging tests to check blood flow), ankle brachial index (ABI) (a test comparing blood pressure in the ankle and arm), physical examination, and skin review.
  • The size of the ulcer should be between 1 and 50 square centimeters, measured by a photo taken during the screening visit.
  • If there are 2 or more ulcers on the same leg, the main ulcer (target ulcer) should be at least 1 centimeter away from other ulcers, with healthy skin in between. The largest ulcer is usually chosen as the target ulcer unless the study doctor decides otherwise.
  • Have a body mass index (BMI) between 15 and 50 kg/m². BMI is a measure of body fat based on height and weight.
  • Understand the study and agree to participate by signing a written consent form before any study procedures begin.
  • Women who can have children must have a negative blood pregnancy test at the first visit.
  • Women who can have children and their partners must agree to use highly effective birth control methods during the study.

Who Cannot Join the Study?

  • Patients who are not within the specified age range for the study.
  • Patients who have medical conditions other than chronic venous ulcers (long-lasting wounds on the legs due to poor blood flow).
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies or reactions to the study medication.
  • Patients with severe health conditions that might interfere with the study.
  • Patients who are unable to give informed consent (agree to participate after understanding the study).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Praxis Dr. med. Abdou Zarzour Halle (Saale) Germany
Die Praxis am Ludwigsplatz Ludwigshafen Am Rhein Germany
Studienzentrum Dr. Beate Schwarz Langenau Germany
Rostock University Medical Center Rostock Germany
Universitaet Leipzig Leipzig Germany
Ruhr-Universität Bochum Bochum Germany

Other Sites

Site Name City Country Status
Klinikum Nuernberg Nürnberg Germany
Klinikum Region Hannover GmbH Hanover Germany
SRH Wald-Klinikum Gera GmbH Gera Germany
HELIOS Klinikum Emil von Behring GmbH Berlin Germany
Beldio Research GmbH Memmingen Germany
Dr. Niesmann And Dr. Othlinghaus GbR Bochum Germany
HELIOS Kliniken Schwerin GmbH Schwerin Germany
HELIOS Klinikum Berlin-Buch GmbH Berlin Germany
St. Josefskrankenhaus Heidelberg GmbH Heidelberg Germany
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Helios Universitaetsklinikum Wuppertal Wuppertal Germany
MVZ Corius Potsdam GmbH Potsdam Germany
Hautarztpraxis Dr. Leitz Und Kollegen Stuttgart Germany
Umfqgubhaxaovufmxykdh Asczbfhx Augsburg Germany
Kritvadiw Fjpzubzmr Duyekdc Goan Dresden Germany
Mpc Pvuuj Duh Ojiyoradb Hpzzo uba Ayhvhwttgzsbmkhefrkvf Gmrw Hanau Germany
Sop Knrryunp Ksyjogcqknfnyfznqfiqorxz Gkoi Karlsbad Germany
Hfvijduoo Bxwujmajqone aa Ainxuhfwswyhf Brunswick Germany
Kyuzymbo Bfjwjvazudmpakagdmbynrgx gzzjr Bremerhaven Germany
Mxnejpxhwigvfn Goulokssjrkwc Gajt Gelsenkirchen Germany
Mlt Guwqtzjkdsuk Abmxjl ag Mzobnvdqhgpfzp Ansnwz Gsdd Aachen Germany
Cuteqpgdqovkirvbifv Srk Jnxbe Regensburg Germany
Liwdxj Mgfhqedjeh Urjhbxrjae Ol Mxjagx Munich Germany
Usqqikysaspzefbmelkkh Mtljykqb Agw Munster Germany
Ufvqkfkerqandvlnccupo Wtyziyxks Azu Wuerzburg Germany
Unfwwhfwuk Mumjgqp Cycfxq Helfutwirydqkhlnk Hamburg Germany
Uwywvrlqjxwyscoyxrjkz Edezj Ahd Essen Germany
Tuklaufnyrd ujd Sgaiytrlahh Bftkhqel Gser Bad Bentheim Germany

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
01.06.2021

Trial locations

Investigated drugs:

allo-APZ2-CVU is an investigational medication being studied for its potential to help heal chronic venous ulcers that have not responded to other treatments. It is applied directly to the wound to see if it can improve wound closure and promote healing. The trial is also monitoring for any side effects to ensure the medication is safe for use.

Chronic Venous Ulcers – Chronic venous ulcers are long-lasting sores that typically occur on the legs due to poor blood circulation in the veins. They develop when the veins in the legs fail to return blood efficiently to the heart, causing increased pressure and fluid buildup. This pressure can damage the skin and underlying tissue, leading to the formation of an ulcer. These ulcers are often painful and can become larger if not properly managed. They may also be accompanied by swelling, itching, and changes in skin color around the affected area. The healing process can be slow, and the ulcers may recur if the underlying venous issues are not addressed.

Trial ID:
2023-510162-27-00
Protocol code:
allo-APZ2-CVU-IIb
NCT ID:
NCT04971161
Trial Phase:
Therapeutic exploratory (Phase II)

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