Application of HydroTac® for venous leg ulcer wound healing
- Conditions
- L97S91Ulcer of lower limb, not elsewhere classifiedOpen wound of ankle and foot
- Registration Number
- DRKS00010236
- Lead Sponsor
- PAUL HARTMANN AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 129
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.
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 <0.8 or pedal pulse missing.
4) According to physician’s assessment, patient’s general condition does not allow or makes it unlikely to take part in treatment duration for 8 weeks.
5) Wound was caused by malign illness (also if venous insufficiency is main cause).
6) Patient suffers from diabetes mellitus with is not adequate adjusted (HbA1c >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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method relative reduction of wound area in % after 8 weeks
- Secondary Outcome Measures
Name Time Method absolute reduction of wound area, number of healed wounds after 8 weeks