Treatment of non-healing ulcers with a dressing based on a innovative nanomaterial
Not Applicable
Completed
- Conditions
- Patients with chronic lower-extremity venous ulcers or traumatic ulcers were object of this trialInjury, Occupational Diseases, PoisoningChronic lower-extremity venous ulcers or traumatic ulcers were object of this trial
- Registration Number
- ISRCTN14756102
- Lead Sponsor
- Ewecare AB
- Brief Summary
2018 Results article in https://pubmed.ncbi.nlm.nih.gov/29889104/ (added 20/09/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
1. Chronic lower limb wounds that were not healed after 6 weeks from the initial injury
2. Treated with eiratex® for the whole treatment
3. Non-infected and infected ulcers
4. Aged from 62 to 85 years old
Exclusion Criteria
1. Patients with exposure of bone, muscle, ligaments, or tendons
2. Patient with mental disorders were excluded to guarantee a conscious agreement to the participation in this study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Healing time is measured by visual examination from the medical doctor. At each treatment visit, information regarding adverse events, medications and other aspects of care since the last visit was acquired.
- Secondary Outcome Measures
Name Time Method 1. Frequency of dressing changes are measured by counting the total number of dressings used during the treatment for each patient, divided by the healing time (in weeks)<br>2. Number of dressings used are measured by the doctor for each patient. The number of dressings used is related to the number needed to heal the wound