been en voet ulcera door (arterio)-veneuze insufficientie chronic lower leg and foot wounds
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Presence of confirmed venous or arterio-venous ulcer. Patients age over 18 years Ulcer duration over 12 weeks and less than 15 years consecutively
Exclusion criteria
Exclusion criteria: Ulcer chronicity 20 mg/per day; Allergy to Gentamycin (which is used in the tissue media), or the used local wound treatments Severe infection of ulcer, active cellulitis, osteomyelitis Expected non compliance with compression therapy, protocol treatment or no informed consent Severe malnutrition Uncontrolled diabetes mellitus, HbA1c > 12% (108 mmol/mol) Anaemia Hb
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety - Assessed by describing the number and type of adverse events; any untoward medical occurrence in a trial participant, even if it does not necessarily have a causal relationship with the treatment, will be reported. 2. Efficacy; assessed by determining: - Time to heal (in weeks) - Number and percentage of closed wounds, within 26 weeks after application of Tiscover or AS210 Complete wound closure is defined as total epithelialization with no wound exudate being present. Digital photographs will record wound closure. - Wound size reduction The percentage of reduction in wound area within 26 weeks after application of Tiscover or AS210 in week 12 and week 26. Wound size is measured with Visitrak® wound measurement system (Smith & Nephew) and wound digital photographs. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recurrence - Number and percentage of closed wounds at 3 and 6 months. 2. Quality of the healed skin - Closed wounds will be visually assessed regarding to scarring. 3. Quality of life - Quality of life measured at baseline, when closed and at 3 and 6 months follow up. Quality of life will be assessed using: i) SF36; Quality of life score ii) Numeric pain rating scale for experienced pain (VAS scale) Take rate of individual Tiscover and AS210 patches. Number and percentage of Tiscover or AS210 patches present on the wound after weekly wound care at weeks 2 - 26 | — |
Countries
Netherlands
Outcome results
None listed