L97 S91
Conditions
Interventions
Group 1: Patients with venous leg ulcer will be treated with wound dressing HydroTac® or HydroTac® comfort. The application and dressing change will be performed according to physician`s suggestion. T
Sponsors
PAUL HARTMANN AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Patient is minimum 18 years of age and has given formal written consent. 2) Patient suffers from Ulcus cruris venosum. 3) Size of ulcera is between 5cm2 and 50cm2. 4) Ulcera persists since min. 3 and max. 36 months and was treated/seen by a physician. 5) Wound surface is covered by vital granulation tissue to a minimum of 50% (can be also achieved by debridement). 6) Patient is treated by compression therapy and is willing to the usage of compression therapy (socks/ bandages) for study duration. 7) Compression therapy is subscribed. Patient has no arterial circulatory disorder with an ankle-brachial pressure index < 0.8 or a missing pedal pulse.
Exclusion criteria
Exclusion criteria: 1) Patient suffers from Ulcus cruris venosum with signs of infection which is treated by antibiotics. 2) Known allergy or intolerance to the study product. 3) Wound has an area with black, necrotic, non-vital tissue or ABI 70 mmol/mol). 7) Patient suffers from severe dysfunction of liver or kidney and/ or is kidney dialysis obligatory. 8) Patient suffers from active autoimmune disorder and is treated with corticosteroid (>10 mg prednisolone equivalent/day) and/or immunosuppressive and/ or chemotherapy. 9) According to physicians assessment, patient is not able to follow study protocol (e.g. due to cognitive disease) or is not able to understand state, nature, meaning and consequences of the study. 10) Patient is not willing or able to apply adequate compression therapy. 11) In addition to study product, further products in direct contact to wound surface will be used. 12) The study-relevant wound was already treated with HydroTac® during the last four weeks before study start. 13) Participation in this study or any other study in the last four weeks before beginning of study. Only for female patients: 14) Patient is pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| relative reduction of wound area in % after 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| absolute reduction of wound area, number of healed wounds after 8 weeks | — |
Countries
Germany, Poland
Contacts
Public ContactWiebke Schröder
PAUL HARTMANN AG
Outcome results
None listed