Skin Ulcer Venous Stasis ChronicPhase 2NCT04971161
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of CVU (Phase IIb)
A Phase 2 study testing allo-APZ2-CVU in people with Skin Ulcer Venous Stasis Chronic, run by RHEACELL GmbH & Co. KG at 38 sites in Germany.
Trial summary
The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size reduction of CVUs) and safety (by monitoring adverse events [AEs]) of three dose groups of the investigational medicinal product (IMP) allo-APZ2-CVU, topically administered on target wounds of patients with CVU compared to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Ulcer Venous Stasis Chronic
- What is being tested?
- allo-APZ2-CVU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 38 sitesGermany
- Study dates
- 18 Aug 2021to 25 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients at least 18 years old;
- Chronic venous leg ulcer (as defined by the current AWMF guidelines: therapy-resistant ulcer that shows no tendency to heal within 3 months despite of optimal phlebological therapies or has not fully healed within 12 months) at lower leg and/or ankle region and has not been present longer than 15 years, diagnosed by doppler or duplex sonography, ankle brachial index (ABI, 0.9-1.3), physical examination and dermatological review;
- Wound size of target ulcer between 1 and 50 cm² measured by a standardized photography at the screening visit;
- If patients have 2 or more ulcers at the same extremity, the target ulcer has to be separated by a minimum bridge of 1 cm of epithelialized skin from other ulcers (the largest ulcer should be the target ulcer, if not decided otherwise at discretion of the investigator; the target ulcer is defined at Visit 1);
- Body mass index between 15 and 50 kg/m²;
- Patients understand the nature of the procedure and are providing written informed consent prior to any clinical trial procedure;
- Women of childbearing potential must have a negative blood pregnancy test at Visit 1;
- Women of childbearing potential and their partner must be willing to use highly effective contraceptive methods during the course of the clinical trial.
Who cannot join
- Evidence of the ulcer extending to the underlying muscle, tendon, or bone;
- Diabetes mellitus that has to be confirmed by blood test (Hemoglobin A1c >7.5%);
- Peripheral Artery Disease including claudication with need of treatment;
- Acute deep vein thrombosis (maximum 30 days from diagnosis) or a still untreated deep vein thrombosis;
- Unable to tolerate leg ulcer compression bandage;
- Infection of the target ulcer requiring treatment as judged clinically;
Show all 18Show fewer
- All diagnosed disorders, unrelated to CVU, that are influencing wound healing of the target wound at investigator's discretion;
- Current use of medications that influence wound healing: systemic immunosuppressives, cytotoxic medicinal products, and systemic steroids (above Cushing-threshold level);
- Patient who, in the opinion of the investigator, for any reason are unable or unwilling to complete the trial per protocol (e.g. alcohol or substance abuse, not mobile, short life expectancy) or there is evidence of any other medical condition (such as psychiatric illness, physical examination, or laboratory findings) that may interfere with the planned treatment, affect the patient's compliance, or place the patient at high risk of complications related to the treatment;
- Any malignancy within the past 5 years, excluding successfully treated carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin without evidence of metastases;
- Pregnant or lactating women;
- Any known allergies to components of the IMP;
- Prior surgical procedures such as bypass or mesh-graft treatment at target leg within 2 months prior to Visit 1 at target leg;
- Patients with significant ulcer healing or wound size enlargement of more than 25% at Visit 2 compared to Visit 1;
- Treatment of target ulcer with active wound care agents (e.g. Iruxol®N), which have not been paused 14 days before IMP application;
- Current or previous (within 30 days of enrollment) treatment with another IMP, or participation and/or under follow-up in another clinical trial;
- Previous participation in this clinical trial (except for screening failures due to an inclusion or exclusion criterion);
- Employees of the sponsor, or employees or relatives of the investigator.
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
Germany38 sites
MVZ Gefäßzentrum Aachen am Marienhospital Aachen GmbH
Aachen, 52066
Universitätsklinikum Augsburg, Klinik für Dermatologie und Allergologie, Campus Süd
Augsburg, 86179
Fachklinik Bad Bentheim, Dermatologische Ambulanz
Bad Bentheim, 48455
Helios Klinikum Berlin-Buch, Klinik für Plastische und Ästhetische Chirurgie
Berlin, 13125
Helios Klinikum Emil von Behring, Klinik für Plastische und Ästhetische Chirurgie
Berlin, 14165
Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus, Hautzentrum im Jahrhunderthaus
Bochum, 44793
Katholisches Klinikum Bochum gGmbH, Venenzentrum der Kliniken für Dermatologie und Gefäßchirurgie der Ruhr-Universität Bochum
Bochum, 44805
Hautärzte Braunschweig am Altstadtmarkt, Hautärztliche Gemeinschaftspraxis
Braunschweig, 38100
Klinikum Bremerhaven Reinkenheide gGmbH, Klinik für Dermatologie, Allergologie und Phlebologie, Wundzentrum
Bremerhaven, 27574
Klinische Forschung Dresden GmbH
Dresden, 01069
Universitätsklinikum Erlangen, Hautklinik - Wundzentrum Dermatologie
Erlangen, 91054
Universitätsklinikum Essen, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
Essen, 45147
Universitätsklinikum Freiburg, Klinik für Dermatologie und Venerologie
Freiburg im Breisgau, 79104
Marienhospital Gelsenkirchen GmbH, Klinik für Chirurgie (Allgemein-, Viszeral- und Endokrine Chirurgie, Thorax-, Gefäß- und Endovaskuläre Chirurgie und Kinderchirurgie)
Gelsenkirchen, 45886
SRH Wald-Klinikum Gera GmbH, Zentrum für Klinische Studien
Gera, 07548
Universitätsmedizin Greifswald, Klinik und Poliklinik für Hautkrankheiten
Greifswald, 17475
Praxis Dr. med. Abdou Zarzour
Halle, 06108
Universitätsklinikum Hamburg- Eppendorf, Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP)
Hamburg, 20246
MVZ Prof. Dr. Ockenfels, Haut und Allergie-Praxisklinik GmbH
Hanau, 63450
Klinikum Region Hannover GmbH, KRH Klinikum Siloah, Klinik für Nephrologie, Angiologie und Rheumatologie
Hanover, 30459
Zentrum für Dermatochirurgie, St. Josefskrankenhaus Heidelberg GmbH
Heidelberg, 69115
SRH Klinikum Karlsbad- Langensteinbach GmbH, Interdisziplinäres Gefäßzentrum Innere Medizin
Karlsbad, 76307
Medizinisches Versorgungszentrum DermaKiel GmbH
Kiel, 24148
Hautarztpraxis Langenau, Studienzentrum
Langenau, 89129
Universitätsklinikum Leipzig AöR, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
Leipzig, 04103
Diabetologikum Ludwigshafen, die Praxis am Ludwigsplatz
Ludwigshafen, 67059
Beldio Research GmbH
Memmingen, 87700
Klinikum der Ludwig-Maximilians-Universität München, Klinik und Poliklinik für Dermatologie und Allergologie
München, 80337
Universitätsklinikum Münster, Klinik für Hautkrankheiten, Allgemeine Dermatologie und Venerologie
Münster, 48149
Klinikum Nürnberg Nord, Klinik für Dermatologie
Nuremberg, 90419
MVZ Corius Potsdam GmbH, Dermatologie Potsdam MVZ
Potsdam, 14467
Caritas-Krankenhaus St. Josef, Klinik für Plastische und Ästhetische, Hand- und Wiederherstellungschirurgie
Regensburg, 93053
Universitätsmedizin Rostock, Klinik und Poliklinik für Dermatologie und Venerologie
Rostock, 18057
Helios Kliniken Schwerin, Plastische, Rekonstruktive und Ästhetische Chirurgie
Schwerin, 19049
Hautärztliche Gemeinschaftspraxis Dr. Leitz und Kollegen
Stuttgart, 70178
Universitätsklinikum Tübingen, Universitäts-Hautklinik Tübingen
Tübingen, 72076
Helios Universitätsklinikum Wuppertal, Zentrums für Dermatologie, Allergologie und Dermatochirurgie
Wuppertal, 42283
Universitätsklinikum Würzburg, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
Würzburg, 97080
About this study
Official title: A Randomized, Placebo-Controlled, Double-blind, Dose-Ranging, Multicenter, Phase IIb Clinical Trial to Investigate the Efficacy and Safety of Allo-APZ2-CVU on Wound Healing of Therapy-Resistant Chronic Venous Ulcer (CVU)
The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size reduction of CVUs) and safety (by monitoring adverse events [AEs]) of three dose groups of the investigational medicinal product (IMP) allo-APZ2-CVU, topically administered on target wounds of patients with CVU compared to placebo.
Read the detailed description
This is a randomized, placebo-controlled, double-blind, dose-ranging, multicenter, phase IIb clinical trial to investigate the efficacy and safety of the IMP allo-APZ2-CVU on wound healing in patients with therapy-resistant CVU. The allogeneic IMP allo-APZ2-CVU contains skin-derived ABCB5-positive dermal mesenchymal stromal cells isolated from skin tissue of healthy donors and stored in a donor cell bank.
Patients will be randomized to be treated with allo-APZ2-CVU (dose 1, dose 2, dose 3) or placebo (50 patients per dose group). The patients will undergo treatment with the IMP on Day 0 (V3) and will be followed up for efficacy for 18 weeks (V4 until V14). Two safety follow-up visits will be performed at Month 6 (V15) and Month 10 (V16). An additional visit (V17) will be performed to follow up on target wounds of all patients who reached the primary endpoint (i.e. wound was closed at V13 and V14) at Month 16 (at least).
The wound healing process will be documented by standardized photography. The wound size measurement will start at the first Screening Visit (V1) and will be measured at each following on-site visit.
Pain will be assessed using a numerical rating scale and quality of life will be investigated with standardized and validated questionnaires.
- Conditions
- Skin Ulcer Venous Stasis Chronic
- Being tested
- allo-APZ2-CVU, Placebo
- Keywords
- Chronic Venous Ulcer, ABCB5, Allogeneic, Dermal mesenchymal stromal cells, varicose ulcer, skin ulcer, advanced therapy medicinal product, somatic cell therapy, phase IIb
- Medical subject headings
- Varicose Ulcer, Skin Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allo-APZ2-CVUBiological
Also called Skin-derived ABCB5-positive dermal mesenchymal stromal cells
Suspension of ABCB5-positive dermal mesenchymal stromal cells. One topical application with a syringe.
PlaceboDrug
One topical application with a syringe
| Study group | Role | What they receive |
|---|---|---|
| allo-APZ2-CVU (dose group 1: 1 x 10e6 cells/cm²) | Experimental | Application of IMP on patients wound Receives: Biological: allo-APZ2-CVU |
| Placebo | Placebo comparator | Application of IMP on patients wound Receives: Drug: Placebo |
| allo-APZ2-CVU (dose group 2: 3 x 10e6 cells/cm²) | Experimental | Application of IMP on patients wound Receives: Biological: allo-APZ2-CVU |
| allo-APZ2-CVU (dose group 3: 6 x 10e6 cells/cm²) | Experimental | Application of IMP on patients wound Receives: Biological: allo-APZ2-CVU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete wound closure at Week 18 already persisting for at least two weeks
Complete wound closure at Week 18 already persisting for at least two weeks will be evaluated.
Measured: Week 18
Assessment of adverse event (AE) occurrence
All AEs occurring during the clinical trial will be registered, documented and evaluated.
Measured: Up to 10 months
Secondary outcomes (11)
Wound size change in percent at each post-baseline follow-up visit
Wound size change in percent at each post-baseline follow-up visit will be evaluated.
Measured: Day 1-2, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, Month 6 and 10
Time to complete wound closure
Time to complete wound closure will be evaluated.
Measured: Day 1-2, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, Month 6 and 10
Complete wound closures at each post-baseline follow-up visit
Complete wound closures at each post-baseline follow-up visit will be evaluated.
Measured: Day 1-2, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, Month 6 and 10, Month 16
Duration of wound closure
Duration of wound closure will be evaluated.
Measured: Day 1-2, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, Month 6 and 10
Recurrence of the wound
Recurrence of the wound will be evaluated.
Measured: Day 1-2, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, Month 6 and 10, Month 16
Quality of wound healing (wound exudate) at each post-baseline follow-up visit
The Quality of wound healing will be assessed at each post-baseline follow-up visit on the basis of the amount and type of wound exudate.
Measured: Day 1-2, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, Month 6 and 10, Month 16
Quality of wound healing (granulation tissue together with epithelialization) at each post-baseline follow-up visit
The Quality of wound healing will be assessed at each post-baseline follow-up visit on the basis of the formation of granulation tissue together with epithelialization.
Measured: Day 1-2, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, Month 6 and 10
Quality of wound healing (scar formation) at each post-baseline follow-up visit
The Quality of wound healing will be assessed at each post-baseline follow-up visit on the basis of the questions regarding scar formation.
Measured: Day 1-2, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, Month 6 and 10
Assessment of Quality of Life using the Wound-Quality of Life Questionnaire at V8, V11, V14, V15, V16
Quality of Life using the Wound-Quality of Life Questionnaire at V8, V11, V14, V15, V16 will be evaluated.
Measured: Week 6, 12, 18, Month 6 and 10
Pain assessment as per numerical rating scale on each post-baseline follow-up visit
Pain assessment as per numerical rating scale on each post-baseline follow-up visit will be evaluated.
Measured: Day 1-2, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, Month 6 and 10
Physical examination and vital signs at V14
A physical body examination (e.g. general appearance, thyroid, head, lungs and thorax, ears, cardiovascular system, eyes, abdomen, nose-mouth-throat, musculoskeletal system, skin, extremities, lymph nodes, neurological system) will be performed and abnormal physical examination results will be evaluated and reported as AEs.
Measured: Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start18 Aug 2021
- Primary completion25 Nov 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Ulcer Venous Stasis ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo-controlled, double-blind, dose-ranging, interventional, multicenter, phase IIb clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- RHEACELL GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Responsible party
- Sponsor
- Investigators
- Andreas Kerstan, Dr., Principal investigator, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Würzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971161
- Sponsor's protocol ID
- allo-APZ2-CVU-IIb
- Other IDs
- 2023-510162-27-00, U1111-1301-6596, 2020-004960-24, 2023
- Status last verified
- Nov 2025
- First submitted
- 7 Jun 2021
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-blind, Dose-Ranging, Multicenter, Phase IIb Clinical Trial to Investigate the Efficacy and Safety of Allo-APZ2-CVU on Wound Healing of Therapy-Resistant Chronic Venous Ulcer (CVU)
- ClinicalTrials.gov ID
- NCT04971161
- Acronym / sponsor ID
- allo-APZ2-CVU-IIb
- Conditions
- Skin Ulcer Venous Stasis Chronic
- Keywords
- Chronic Venous Ulcer, ABCB5, Allogeneic, Dermal mesenchymal stromal cells, varicose ulcer, skin ulcer, advanced therapy medicinal product, somatic cell therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- RHEACELL GmbH & Co. KGIndustry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size reduction of CVUs) and safety (by monitoring adverse events [AEs]) of three dose groups of the investigational medicinal product (IMP) allo-APZ2-CVU, topically administered on target wounds of patients with CVU compared to placebo.
Detailed description
This is a randomized, placebo-controlled, double-blind, dose-ranging, multicenter, phase IIb clinical trial to investigate the efficacy and safety of the IMP allo-APZ2-CVU on wound healing in patients with therapy-resistant CVU. The allogeneic IMP allo-APZ2-CVU contains skin-derived ABCB5-positive dermal mesenchymal stromal cells isolated from skin tissue of healthy donors and stored in a donor cell bank.
Patients will be randomized to be treated with allo-APZ2-CVU (dose 1, dose 2, dose 3) or placebo (50 patients per dose group). The patients will undergo treatment with the IMP on Day 0 (V3) and will be followed up for efficacy for 18 weeks (V4 until V14). Two safety follow-up visits will be performed at Month 6 (V15) and Month 10 (V16). An additional visit (V17) will be performed to follow up on target wounds of all patients who reached the primary endpoint (i.e. wound was closed at V13 and V14) at Month 16 (at least).
The wound healing process will be documented by standardized photography. The wound size measurement will start at the first Screening Visit (V1) and will be measured at each following on-site visit.
Pain will be assessed using a numerical rating scale and quality of life will be investigated with standardized and validated questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Randomized, placebo-controlled, double-blind, dose-ranging, interventional, multicenter, phase IIb clinical trial
| Arm | Type | Receives |
|---|---|---|
| allo-APZ2-CVU (dose group 1: 1 x 10e6 cells/cm²) | Experimental | Biological: allo-APZ2-CVUApplication of IMP on patients wound |
| Placebo | Placebo comparator | Drug: PlaceboApplication of IMP on patients wound |
| allo-APZ2-CVU (dose group 2: 3 x 10e6 cells/cm²) | Experimental | Biological: allo-APZ2-CVUApplication of IMP on patients wound |
| allo-APZ2-CVU (dose group 3: 6 x 10e6 cells/cm²) | Experimental | Biological: allo-APZ2-CVUApplication of IMP on patients wound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients at least 18 years old;
- Chronic venous leg ulcer (as defined by the current AWMF guidelines: therapy-resistant ulcer that shows no tendency to heal within 3 months despite of optimal phlebological therapies or has not fully healed within 12 months) at lower leg and/or ankle region and has not been present longer than 15 years, diagnosed by doppler or duplex sonography, ankle brachial index (ABI, 0.9-1.3), physical examination and dermatological review;
- Wound size of target ulcer between 1 and 50 cm² measured by a standardized photography at the screening visit;
- If patients have 2 or more ulcers at the same extremity, the target ulcer has to be separated by a minimum bridge of 1 cm of epithelialized skin from other ulcers (the largest ulcer should be the target ulcer, if not decided otherwise at discretion of the investigator; the target ulcer is defined at Visit 1);
- Body mass index between 15 and 50 kg/m²;
Key exclusion criteria (18 listed)
- Evidence of the ulcer extending to the underlying muscle, tendon, or bone;
- Diabetes mellitus that has to be confirmed by blood test (Hemoglobin A1c >7.5%);
- Peripheral Artery Disease including claudication with need of treatment;
- Acute deep vein thrombosis (maximum 30 days from diagnosis) or a still untreated deep vein thrombosis;
- Unable to tolerate leg ulcer compression bandage;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allo-APZ2-CVUAlso: Skin-derived ABCB5-positive dermal mesenchymal stromal cellsSuspension of ABCB5-positive dermal mesenchymal stromal cells. One topical application with a syringe. | Biological | allo-APZ2-CVU (dose group 1: 1 x 10e6 cells/cm²), allo-APZ2-CVU (dose group 2: 3 x 10e6 cells/cm²), allo-APZ2-CVU (dose group 3: 6 x 10e6 cells/cm²) |
| PlaceboOne topical application with a syringe | Drug | Placebo |
Primary outcome
Complete wound closure at Week 18 already persisting for at least two weeks
Time frame: Week 18
Complete wound closure at Week 18 already persisting for at least two weeks will be evaluated.
Assessment of adverse event (AE) occurrence
Time frame: Up to 10 months
All AEs occurring during the clinical trial will be registered, documented and evaluated.
11 secondary outcomes
Wound size change in percent at each post-baseline follow-up visit
Time frame: Day 1-2, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, Month 6 and 10
Time to complete wound closure
Time frame: Day 1-2, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, Month 6 and 10
Complete wound closures at each post-baseline follow-up visit
Time frame: Day 1-2, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, Month 6 and 10, Month 16
Duration of wound closure
Time frame: Day 1-2, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, Month 6 and 10
Recurrence of the wound
Time frame: Day 1-2, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, Month 6 and 10, Month 16
Quality of wound healing (wound exudate) at each post-baseline follow-up visit
Time frame: Day 1-2, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, Month 6 and 10, Month 16
Quality of wound healing (granulation tissue together with epithelialization) at each post-baseline follow-up visit
Time frame: Day 1-2, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, Month 6 and 10
Quality of wound healing (scar formation) at each post-baseline follow-up visit
Time frame: Day 1-2, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, Month 6 and 10
Assessment of Quality of Life using the Wound-Quality of Life Questionnaire at V8, V11, V14, V15, V16
Time frame: Week 6, 12, 18, Month 6 and 10
Pain assessment as per numerical rating scale on each post-baseline follow-up visit
Time frame: Day 1-2, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, Month 6 and 10
Physical examination and vital signs at V14
Time frame: Week 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Kerstan, Dr. principal investigator
Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Würzburg
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing allo-APZ2-CVU in people with Skin Ulcer Venous Stasis Chronic, run by RHEACELL GmbH & Co. KG at 38 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete wound closure at Week 18 already persisting for at least two weeks (time frame: Week 18). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.