<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03267784</url>
  </required_header>
  <id_info>
    <org_study_id>allo-APZ2-DFU-II-01</org_study_id>
    <nct_id>NCT03267784</nct_id>
  </id_info>
  <brief_title>Allogeneic ABCB5-positive Stem Cells for Treatment of DFU &quot;Malum Perforans&quot;</brief_title>
  <official_title>An Interventional, Multicenter, Single Arm, Phase I/IIa Clinical Trial to Investigate the Efficacy and Safety of Allo-APZ2-DFU on Wound Healing of Diabetic Neuropathic Ulcer (DFU)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RHEACELL GmbH &amp; Co. KG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>FGK Clinical Research GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ticeba GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Granzer Regulatory Consulting &amp; Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>RHEACELL GmbH &amp; Co. KG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this clinical trial is to investigate the efficacy (by monitoring the wound&#xD;
      surface area reduction of Diabetic Foot Ulcers) and safety (by monitoring adverse events) of&#xD;
      two doses of the allogeneic investigational medicinal product &quot;allo-APZ2-DFU&quot; topically&#xD;
      administered to the wound matrix of patients with diabetic neuropathic ulcer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an interventional, single arm, phase I/IIa clinical trial to investigate the efficacy&#xD;
      and safety of allogeneic ABCB5-positive mesenchymal stem cells (MSCs) on wound healing in&#xD;
      patients with diabetic neuropathic ulcer. Allogeneic MSCs will be isolated ex vivo and will&#xD;
      be expanded in vitro. The Investigational medicinal product (IMP) containing the&#xD;
      ABCB5-positive MSCs will then be applied two times (at Visit 3 and six weeks later, at Visit&#xD;
      10) on the wound surface of DFU.&#xD;
&#xD;
      Patients are followed up for efficacy for a period of three months starting after the first&#xD;
      IMP application which allows to distinguish actual wound healing from transient wound&#xD;
      coverage.&#xD;
&#xD;
      The wound healing process will be documented by standardized photography. The wound size&#xD;
      reduction evaluation will start two weeks after the first IMP application. The quality of the&#xD;
      wound healing process will be assessed on the basis of formation of granulation tissue,&#xD;
      epithelialization and wound exudation.&#xD;
&#xD;
      Pain will be assessed using a numerical rating scale and quality of life will be investigated&#xD;
      with standardized and validated questionnaires. To assess long-term safety of allo-APZ2-DFU&#xD;
      three follow-up visits at Months 6, 9 and 12 after the first IMP application are included.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 21, 2017</start_date>
  <completion_date type="Actual">June 29, 2020</completion_date>
  <primary_completion_date type="Actual">June 29, 2020</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single Group Assignment Interventional, single arm, multicenter, phase I/IIa clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of wound surface area reduction</measure>
    <time_frame>Week 12, or last available post-baseline measurement of weeks 4, 6 or 8 if the Week 12 measurement is missing.</time_frame>
    <description>Percentage of wound surface area reduction at Week 12, or last available post-baseline measurement of weeks 4, 6 or 8, if the Week 12 measurement is missing (last observation carried forward [LOCF]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of adverse event (AE) occurrence</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>All AEs occurring during the clinical trial will be registered, documented and evaluated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of wound surface area reduction</measure>
    <time_frame>Weeks 2, 4, 6, 8 and 12 (without LOCF)</time_frame>
    <description>Percentage of wound surface area reduction will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of invisible and visible wound surface area reduction</measure>
    <time_frame>Weeks 2, 4, 6, 8 and 12 (without LOCF)</time_frame>
    <description>Percentage of invisible and visible wound surface area reduction will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute wound surface area reduction</measure>
    <time_frame>Weeks 2, 4, 6, 8 and 12 (without LOCF)</time_frame>
    <description>Absolute wound surface area reduction will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute invisible and visible wound surface area reduction</measure>
    <time_frame>Weeks 2, 4, 6, 8 and 12 (without LOCF)</time_frame>
    <description>Absolute invisible and visible wound surface area reduction will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of wound infection</measure>
    <time_frame>Days 1 and 2, Weeks 1, 2, 4, 6, 6.1, 6.2, 6.3, 8 and 12</time_frame>
    <description>Wound infection will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first complete wound closure</measure>
    <time_frame>A priori specification not possible; between baseline and week 12 post baseline</time_frame>
    <description>Time to first complete wound closure will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients achieving complete wound closure</measure>
    <time_frame>Weeks 2, 4, 6, 8 and 12</time_frame>
    <description>Proportion of patients achieving complete wound closure will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first 30% reduction of wound surface area</measure>
    <time_frame>A priori specification not possible; between baseline and week 12 post baseline</time_frame>
    <description>Time to first 30% reduction of wound surface area will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients achieving 30% reduction of wound surface area</measure>
    <time_frame>Weeks 2, 4, 6, 8 and 12</time_frame>
    <description>Proportion of patients achieving 30% reduction of wound surface area will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of wound exudation, epithelialization and formation of granulation tissue</measure>
    <time_frame>Day 0 and Week 6.1 prior IMP-application, at Weeks 1, 2, 4, 6, 8 and 12</time_frame>
    <description>Wound exudation, epithelialization and formation of granulation tissue will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to amputation at target leg until Week 12</measure>
    <time_frame>A priori specification not possible; between baseline and week 12 post baseline</time_frame>
    <description>Time to amputation at target leg until week 12 will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessment as per numerical rating scale (NRS)</measure>
    <time_frame>At both Screening Visits, at Days 0, 1 and 2 and at Weeks 1, 2, 4, 6, 6.1, 6.2, 6.3, 8 and 12</time_frame>
    <description>Pain assessment as per numerical rating scale (NRS) will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Quality of life (QoL) using the short form 36 (SF-36) questionnaire</measure>
    <time_frame>Screening Visit 1, Visit 3, at Weeks 4 and 12</time_frame>
    <description>Quality of life (QoL) using the short form 36 (SF-36) questionnaire will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Dermatology-specific QoL based on the Dermatology Life Quality Index (DLQI) questionnaire</measure>
    <time_frame>Screening Visit 1, Visit 3, at Weeks 4 and 12</time_frame>
    <description>Dermatology-specific QoL based on the Dermatology Life Quality Index (DLQI) questionnaire will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical examination and vital signs</measure>
    <time_frame>Week 6.1 and Week 12</time_frame>
    <description>Physical examination and vital signs will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to amputation of target leg until month 12</measure>
    <time_frame>A priori specification not possible; between baseline and month 12 post baseline</time_frame>
    <description>Time to amputation of target leg until month 12 will be evaluated.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Diabetic Neuropathic Ulcer</condition>
  <arm_group>
    <arm_group_label>Experimental: allo-APZ2-DFU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Application of IMP on patients wound</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>allo-APZ2-DFU</intervention_name>
    <description>Suspension of ABCB5-positive mesenchymal stem cells</description>
    <arm_group_label>Experimental: allo-APZ2-DFU</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patients aged 18 to 85 years;&#xD;
&#xD;
          2. Patients with an existing diagnosis of diabetic mellitus Type 2, evaluated by blood&#xD;
             test [HbA1c] &lt; 11%) at the Screening visit (Visit 1). The HbA1c value at visit 1&#xD;
             should not vary more than 1.5% (absolute range) compared to a HbA1c value that was&#xD;
             previously measured 1 to 6 months before visit 1;&#xD;
&#xD;
          3. The presence of diabetic neuropathic ulcers &quot;malum perforans&quot; (Grade I and II&#xD;
             according to Wagner) at plantar site of the foot diagnosed by ABI ≥0.7, without&#xD;
             claudication, or TcPO2 &gt;40 mmHg or doppler ultrasonography (at the discretion of the&#xD;
             investigator) to exclude significant arterial diseases and critical limb ischemia, and&#xD;
             a diabetic neuropathy test using a 128 Hz vibration tuning fork according to&#xD;
             Rydel-Seiffer (as described by Guideline &quot;Nationale Versorgungsleitlinie - Neuropathie&#xD;
             bei Diabetes im Erwachsenenalter&quot;). If the ABI is &gt;1.3, an additional doppler&#xD;
             ultrasonography must be performed to exclude a PAOD masked by media sclerosis;&#xD;
&#xD;
          4. At Screening Visit 1 and 2 the wound surface area of the target ulcer should be&#xD;
             between 1 and 50 cm2 measured by using a scaled measuring sensor in combination with&#xD;
             digital image analysis;&#xD;
&#xD;
          5. The ulcer's surface area should be (mostly) free from callus or necrotic tissue;&#xD;
&#xD;
          6. If patients are suffering from two or more ulcers at the same extremity, the target&#xD;
             ulcer has to be separated by a minimum bridge of 1 cm of healthy tissue from other&#xD;
             ulcers;&#xD;
&#xD;
          7. Patients are willing and able to wear therapeutic shoes that are especially designed&#xD;
             for patients with a diabetic neuropathic foot;&#xD;
&#xD;
          8. Body mass index (BMI) between 20 and 45 kg/m²;&#xD;
&#xD;
          9. Patients understand the nature of the procedure and are providing written informed&#xD;
             consent prior to any clinical trial procedure;&#xD;
&#xD;
         10. Women of childbearing potential must have a negative blood pregnancy test at Visit 1;&#xD;
&#xD;
         11. Women of childbearing potential must be willing to use highly effective contraceptive&#xD;
             methods during the course of the clinical trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of acute Charcot foot;&#xD;
&#xD;
          2. Clinical signs of active osteomyelitis in the last three months;&#xD;
&#xD;
          3. Active wet gangrenous tissue;&#xD;
&#xD;
          4. Infection of the target ulcer requiring treatment as judged clinically;&#xD;
&#xD;
          5. Presence of an ulcer Grade ≥3 according to Wagner on the same foot as target ulcer;&#xD;
&#xD;
          6. Patients who are currently receiving dialysis;&#xD;
&#xD;
          7. Peripheral arterial occlusive disease (PAOD) including claudication with need of&#xD;
             treatment;&#xD;
&#xD;
          8. Ulcers due to non-diabetic etiology;&#xD;
&#xD;
          9. Prior surgical procedures such as bypass or mesh-graft treatment within 2 months prior&#xD;
             to IMP application;&#xD;
&#xD;
         10. Acute deep vein thrombosis (maximum 30 days from diagnosis) or a still untreated deep&#xD;
             vein thrombosis;&#xD;
&#xD;
         11. Any chronic dermatological disorders diagnosed at the investigator's discretion;&#xD;
&#xD;
         12. Skin disorders, unrelated to the ulcer, that are present adjacent to the target wound;&#xD;
&#xD;
         13. Treatment of target wound with active wound care agents (e.g. iruxol, local&#xD;
             antibiotics or silver dressings), which have not been stopped 14 days before IMP&#xD;
             application;&#xD;
&#xD;
         14. Any malignancy within the past 5 years, excluding successfully treated carcinoma in&#xD;
             situ, basal cell carcinoma or squamous cell carcinoma of the skin without evidence of&#xD;
             metastases;&#xD;
&#xD;
         15. Current use of steroid medication above Cushing threshold dose (&gt;7.5 mg/d prednisone&#xD;
             or equivalent);&#xD;
&#xD;
         16. Known abuse of alcohol, drugs, or medicinal products;&#xD;
&#xD;
         17. Patients anticipated to be unwilling or unable to comply with the requirements of the&#xD;
             protocol;&#xD;
&#xD;
         18. Pregnant or lactating women;&#xD;
&#xD;
         19. Patients infected with the human immunodeficiency virus (HIV 1&amp;2);&#xD;
&#xD;
         20. Any known allergies to components of the IMP or concomitant medication;&#xD;
&#xD;
         21. Current or previous (within 30 days of enrollment) treatment with another IMP, or&#xD;
             participation and/or under follow-up in another clinical trial;&#xD;
&#xD;
         22. Evidence of any other medical conditions (such as psychiatric illness, physical&#xD;
             examination, or laboratory findings) that may interfere with the planned treatment,&#xD;
             affect the patient's compliance, or place the patient at high risk of complications&#xD;
             related to the treatment;&#xD;
&#xD;
         23. Employees of the sponsor, or employees or relatives of the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas Kerstan, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Würzburg, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitätsmedizin Greifswald; Klinik und Poliklinik für Hautkrankheiten</name>
      <address>
        <city>Greifswald</city>
        <zip>17475</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Josefskrankenhaus Heidelberg GmbH; Klinische Studienabteilung</name>
      <address>
        <city>Heidelberg</city>
        <zip>69115</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetologikum Raab, Privatärztliche Facharztpraxis</name>
      <address>
        <city>Kassel</city>
        <zip>34131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>pro scientia med im Mare Klinikum, Department Klinische Forschung und Entwicklung</name>
      <address>
        <city>Kronshagen</city>
        <zip>24119</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Studienambulanz Leipzig, medamed GmbH</name>
      <address>
        <city>Leipzig</city>
        <zip>04107</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetologikum Ludwigshafen, Gemeinschaftspraxis</name>
      <address>
        <city>Ludwigshafen</city>
        <zip>67059</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Universitätsklinikum Würzburg</name>
      <address>
        <city>Würzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>September 9, 2020</last_update_submitted>
  <last_update_submitted_qc>September 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diabetic neuropathic ulcer</keyword>
  <keyword>ABCB5</keyword>
  <keyword>allogeneic</keyword>
  <keyword>mesenchymal stem cells</keyword>
  <keyword>skin ulcer</keyword>
  <keyword>advanced therapy medicinal product</keyword>
  <keyword>somatic cell therapy</keyword>
  <keyword>phase I/IIa</keyword>
  <keyword>Diabetic Foot Ulcer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03267784
org study id: allo-APZ2-DFU-II-01
nct id: NCT03267784
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this clinical trial is to investigate the efficacy (by monitoring the wound
      surface area reduction of Diabetic Foot Ulcers) and safety (by monitoring adverse events) of
      two doses of the allogeneic investigational medicinal product "allo-APZ2-DFU" topically
      administered to the wound matrix of patients with diabetic neuropathic ulcer.
This is an interventional, single arm, phase I/IIa clinical trial to investigate the efficacy
      and safety of allogeneic ABCB5-positive mesenchymal stem cells (MSCs) on wound healing in
      patients with diabetic neuropathic ulcer. Allogeneic MSCs will be isolated ex vivo and will
      be expanded in vitro. The Investigational medicinal product (IMP) containing the
      ABCB5-positive MSCs will then be applied two times (at Visit 3 and six weeks later, at Visit
      10) on the wound surface of DFU.

      Patients are followed up for efficacy for a period of three months starting after the first
      IMP application which allows to distinguish actual wound healing from transient wound
      coverage.

      The wound healing process will be documented by standardized photography. The wound size
      reduction evaluation will start two weeks after the first IMP application. The quality of the
      wound healing process will be assessed on the basis of formation of granulation tissue,
      epithelialization and wound exudation.

      Pain will be assessed using a numerical rating scale and quality of life will be investigated
      with standardized and validated questionnaires. To assess long-term safety of allo-APZ2-DFU
      three follow-up visits at Months 6, 9 and 12 after the first IMP application are included.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single Group Assignment Interventional, single arm, multicenter, phase I/IIa clinical trial
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of wound surface area reduction
time frame: Week 12, or last available post-baseline measurement of weeks 4, 6 or 8 if the Week 12 measurement is missing.
description: Percentage of wound surface area reduction at Week 12, or last available post-baseline measurement of weeks 4, 6 or 8, if the Week 12 measurement is missing (last observation carried forward [LOCF]).
measure: Assessment of adverse event (AE) occurrence
time frame: Up to 12 months
description: All AEs occurring during the clinical trial will be registered, documented and evaluated.
measure: Percentage of wound surface area reduction
time frame: Weeks 2, 4, 6, 8 and 12 (without LOCF)
description: Percentage of wound surface area reduction will be evaluated.
measure: Percentage of invisible and visible wound surface area reduction
time frame: Weeks 2, 4, 6, 8 and 12 (without LOCF)
description: Percentage of invisible and visible wound surface area reduction will be evaluated.
measure: Absolute wound surface area reduction
time frame: Weeks 2, 4, 6, 8 and 12 (without LOCF)
description: Absolute wound surface area reduction will be evaluated.
measure: Absolute invisible and visible wound surface area reduction
time frame: Weeks 2, 4, 6, 8 and 12 (without LOCF)
description: Absolute invisible and visible wound surface area reduction will be evaluated.
measure: Assessment of wound infection
time frame: Days 1 and 2, Weeks 1, 2, 4, 6, 6.1, 6.2, 6.3, 8 and 12
description: Wound infection will be evaluated.
measure: Time to first complete wound closure
time frame: A priori specification not possible; between baseline and week 12 post baseline
description: Time to first complete wound closure will be evaluated.
measure: Proportion of patients achieving complete wound closure
time frame: Weeks 2, 4, 6, 8 and 12
description: Proportion of patients achieving complete wound closure will be evaluated.
measure: Time to first 30% reduction of wound surface area
time frame: A priori specification not possible; between baseline and week 12 post baseline
description: Time to first 30% reduction of wound surface area will be evaluated.
measure: Proportion of patients achieving 30% reduction of wound surface area
time frame: Weeks 2, 4, 6, 8 and 12
description: Proportion of patients achieving 30% reduction of wound surface area will be evaluated.
measure: Assessment of wound exudation, epithelialization and formation of granulation tissue
time frame: Day 0 and Week 6.1 prior IMP-application, at Weeks 1, 2, 4, 6, 8 and 12
description: Wound exudation, epithelialization and formation of granulation tissue will be evaluated.
measure: Time to amputation at target leg until Week 12
time frame: A priori specification not possible; between baseline and week 12 post baseline
description: Time to amputation at target leg until week 12 will be evaluated.
measure: Pain assessment as per numerical rating scale (NRS)
time frame: At both Screening Visits, at Days 0, 1 and 2 and at Weeks 1, 2, 4, 6, 6.1, 6.2, 6.3, 8 and 12
description: Pain assessment as per numerical rating scale (NRS) will be evaluated.
measure: Assessment of Quality of life (QoL) using the short form 36 (SF-36) questionnaire
time frame: Screening Visit 1, Visit 3, at Weeks 4 and 12
description: Quality of life (QoL) using the short form 36 (SF-36) questionnaire will be evaluated.
measure: Assessment of Dermatology-specific QoL based on the Dermatology Life Quality Index (DLQI) questionnaire
time frame: Screening Visit 1, Visit 3, at Weeks 4 and 12
description: Dermatology-specific QoL based on the Dermatology Life Quality Index (DLQI) questionnaire will be evaluated.
measure: Physical examination and vital signs
time frame: Week 6.1 and Week 12
description: Physical examination and vital signs will be evaluated.
measure: Time to amputation of target leg until month 12
time frame: A priori specification not possible; between baseline and month 12 post baseline
description: Time to amputation of target leg until month 12 will be evaluated.
arm group label: Experimental: allo-APZ2-DFU
arm group type: Experimental
description: Application of IMP on patients wound
intervention type: Biological
intervention name: allo-APZ2-DFU
description: Suspension of ABCB5-positive mesenchymal stem cells
arm group label: Experimental: allo-APZ2-DFU
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Andreas Kerstan, Dr.
role: Principal Investigator
affiliation: Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Würzburg, Germany
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Ulcer
sharing ipd: No