Chronic venous ulcers (CVU) MedDRA version: 20.0 Level: LLT Classification code 10066677 Term: Chronic leg ulcer System Organ Class: 100000004858
Conditions
Interventions
Product Name: APZ2
Product Code: APZ2
Pharmaceutical Form: Cutaneous suspension
Other descriptive name: APZ1
Concentration unit: million organisms/ml million organisms/millilitre
Concentration type: e
Sponsors
RHEACELL GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18 to 85 years; 2. Chronic venous leg ulcer (as defined by the current AWMF guidelines: therapy resistant ulcer that shows no improvement within 3 months despite of optimal phlebological therapies or is not healed within 12 months) for at least 6 weeks but shorter than 3 years diagnosed by doppler ultrasonography (DUS), ankle brachial index (ABI, 0.9–1.3), physical examination and dermatological review; 3. Wound size between 5 and 50 cm2 measured by a standardized photography at the screening visit; 4. Wound location between knee and ankle; 5. Patients suffering from 2 or more ulcers at the same extremity, as long as these ulcers are separated by a minimum bridge of 1 cm of epithelialized skin; 6. Patients must agree to have at least one biopsy performed before treatment. In case IMP production from the first biopsy is not successful, a second biopsy will be taken; 7. Body mass index (BMI) between 20 and 40 kg/m²; 8. Patients understand the nature of the procedure and are providing written informed consent prior to any clinical trial procedure; 9. Women of childbearing potential must have a negative blood pregnancy test at Screening and at Visit 5 before the IMP application; 10. Women of childbearing potential and their partner must be willing to use highly effective contraceptive methods during the course of the clinical trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 27
Exclusion criteria
Exclusion criteria: General exclusion criteria 1. Evidence of the ulcer extending to the underlying muscle, tendon, or bone; 2. Current long-term use (more than 14 days) of steroid medication above Cushing-threshold dose (>7.5 mg/d prednisone or equivalent); 3. Diabetes mellitus that has to be evaluated by blood test (Hemoglobin A1c [HbA1c] > 7,5 %); 4. Peripheral Artery Disease (PAD) including claudication with need of treatment; 5. Acute deep vein thrombosis (maximum 30 days from diagnosis) or a still untreated deep vein thrombosis; 6. Unable to tolerate leg ulcer compression bandage; 7. Infection of the target ulcer requiring treatment as judged clinically; 8.Wound size <1.5 cm² measured by a standardized photography at Visit 5; 9. Any chronic dermatological disorders diagnosed at the investigator’s discretion; 10. Skin disorders, unrelated to the ulcer, that are present adjacent to the target wound; 11. Current use of medications that influence wound healing: systemic immunosuppressives, cytotoxic medicinal products, and systemic steroids (above Cushing-threshold level); 12. Known abuse of alcohol, drugs, or medicinal products; 13. Cancerous or pre-cancerous lesions adjacent to the target wound; 14. Patients anticipated to be unwilling or unable to comply with the requirements of the protocol; 15. Pregnant or lactating women; 16. Systemic infectious disease diagnosed by serology testing for syphilis (acute), human immunodeficiency virus (HIV?1, HIV-2), hepatitis B (acute) or C infection at Screening or at Visit 2; 17. Any known allergies to components of the IMP; 18. Prior surgical procedures such as bypass or mesh-graft treatment within 2 months prior to IMP application; 19. Treatment of target ulcer with active wound care agents (e.g. Iruxol, local antibiotics or silver dressings), which have not been paused 14 days before IMP application; 20. Current or previous (within 30 days of enrollment) treatment with another IMP, or participation and/or under follow-up in another clinical trial; 21. Previous participation in this clinical trial; 22. Evidence of any other medical conditions (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; 23. Employees of the sponsor, or employees or relatives of the investigator. Exclusion criteria for efficacy assessments 1. A wound size enlargement of more than 25% between the wound assessment at the screening visit and the wound assessment at Visit 5; 2. A wound size reduction of more than 50% between the wound assessment at the screening visit and wound assessment at Visit 5.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy and safety evaluation of one dose of the IMP topically administered on wounds of patients with CVU.;Secondary Objective: Not applicable;Primary end point(s): 1. Percentage of wound size reduction 2. Assessment of AE occurrence;Timepoint(s) of evaluation of this end point: 1. Week 12 post baseline, or last available post-baseline measurement if the Week 12 measurement is missing 2. During all patient visits except screening | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percentage of wound size reduction 2. Absolute wound size reduction 3. Proportion of patients achieving complete wound closure 4. Time to first complete wound closure 5. Proportion of patients achieving 30% wound closure 6. Time to first 30% wound closure 7. Epithelialization 8. Formulation of granulation tissue and wound exudation 9. Pain assessment as per numerical rating scale (NRS) 10. Quality of life (QoL) assessment using the SF-36 questionnaire 11. Dermatologic quality of life assessment using the DLQI questionnaire 12. Physical examination and vital parameters;Timepoint(s) of evaluation of this end point: 1. Weeks 2, 3, 4, 6, 8, 10 and 12 post baseline. 2. Weeks 2, 3, 4, 6, 8, 10, and 12 post baseline. 3. Weeks 2, 3, 4, 6, 8, 10, and 12 post baseline and at any time point up to week 12. 4. A priori specification not possible; between baseline and week 12 post baseline 5. Weeks 2, 3, 4, 6, 8, 10, 12 post baseline. 6. A priori specification not possible; between baseline and week 12 post baseline 7. Weeks 2, 3, 4, 6, 8, 10, 12 post baseline. 8. At baseline and days 3, 8 and weeks 2, 3, 4, 6, 8, 10, 12 post baseline. 9. At baseline and days 3, 8 and weeks 2, 3, 4, 6, 8, 10, 12 post baseline. 10. At baseline and weeks 4, 8, 12 post baseline. 11. At baseline and weeks 4, 8, 12 post baseline. 12. At Screening, baseline, week 12, month 12. | — |
Countries
Germany
Contacts
Public ContactInformation Office
RHEACELL GmbH & Co. KG
Outcome results
None listed