Silica Gel Fiber is a bioresorbable, inorganic silica gel fibre patch promoting skin tissue growth and enhanced wound healing for all types of chronic wounds. It is applied as patch and will be hold in place by a secondary dressing for maintaining the moist wound environment. The study is aimed to demonstrate superiority over a standard wound treatment for chronic venous leg ulcers. The primary efficacy variable is time to healing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
121
Silica Gel Fiber (SGF) applications as required
Standard-of-Care with dressing changes twice per week using Mepitel and Mepilex wound dressings
Unnamed facility
Berlin, Germany
Unnamed facility
Bochum, Germany
Unnamed facility
Bonn, Germany
Unnamed facility
Cologne, Germany
Time to healing of target ulcer, defined as the treatment period day during the weekly visit at which the surface area of the wound was noted as zero and completely healed
Time frame: Week 12
Incidence of complete wound healing of target ulcer at 4, 8 and 12 weeks, defined as full epithelialisation of the wound with the absence of drainage
Time frame: Week 4/8/12
Rate of recurrence of wound at end of follow-up period of 3 months
Time frame: Week 24
Size (cm2, measured by Visitrak Wound Measurement System) of target ulcer (Absolute size measured once per week and change between assessments at weeks 0, 4, 8, and 12)
Time frame: Week 12/24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Dresden, Germany
Unnamed facility
Essen, Germany
Unnamed facility
Frankfurt, Germany
Unnamed facility
Freiburg im Breisgau, Germany
Unnamed facility
Göttingen, Germany
Unnamed facility
Greifswald, Germany
...and 4 more locations