A prospective, randomised, controlled Study evaluating the effect of waterfiltered infrared A radiation (wIRA) on wound healing of venous leg ulcers
- Conditions
- I83.2Varicose veins of lower extremities with both ulcer and inflammation
- Registration Number
- DRKS00000669
- Lead Sponsor
- niversitäts-Hautklinik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 51
patients over 18 years with
ulcers of the lower legs of predominantly venous genesis
(brachio-pedal index >0.6, wedge pressures >60 mm Hg);
chronic state (lasting more than 6 weeks with
no tendency to heal under the previous therapy);
ulcer size of 1–200 cm².
vascular surgical or other vascular interventions in the area of the lower extremities within the last 6 weeks prior to inclusion in the study;
prior inclusion in this study; inclusion in an other study at the time of inclusion in this study;physical or mental illnesses (including severe accompanying basic illnesses, e.g. cancer, AIDS, severe anaemia, insufficiently treated diabetes mellitus) which do not allow participation in the treatment procedure of the study;
peripheral arterial occlusive disease (with clinical signs for a critical ischaemia, a brachio-pedal index <0.6 or a wedge pressure of the ankle or arch of the foot <60 mm Hg);
oral antibiotic treatment of the ulcer
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wound closure or wound size reduction of a treatment intervall of maximum 13 weeks.
- Secondary Outcome Measures
Name Time Method Change of wound exsudation, pain, granulation, coatings, epithelialization during therapy.