Venous Ulcer
Conditions
Keywords
Silica gel fiber, Chronic venous leg ulcers, Venous ulcer, Stasis ulcer, Varicose ulcer
Brief summary
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.
Interventions
DEVICESilica Gel Fiber
Silica Gel Fiber (SGF) applications as required
DEVICEStandard-of-Care
Standard-of-Care with dressing changes twice per week using Mepitel and Mepilex wound dressings
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least one chronic venous leg ulcer fulfilling all of the following criteria: * Size: \>/= 5 cm2 and \</= 40 cm2 (measured by Visitrak Wound Measurement System) * Duration: \>/= 3 month \< 5 years * Location: Between and including knee and ankle * Depth: Involving dermis, with no exposed muscle, tendon or bone. Characterized by a viable wound bed with granulation tissue * The etiology of the ulcer as venous is proven by Duplex or Doppler sonography and with ankle/brachial arterial Doppler pressure index \> 0.8 (exclusion criterion for peripheral arterial disease) and \< 1.3 (exclusion criterion for medial sclerosis), or with a laser Doppler value \> 40 * Treatment with active wound care agents paused for 14 days before start of study treatment
Exclusion criteria
* Only ulcers of other than venous etiology, e.g., diabetic ulcers or ulcers resulting from electrical, chemical, or radiation insult, after contact eczema, etc. * History of radiotherapy to the target ulcer site * Signs of infection as defined by rubor, dolor, calor, tumor, functio laesa. Fever (38°C sublingual, rectal, or ear), rigors, or leukocytosis will be considered as signs of infection in the context of the general appearance of the wound * Target ulcer lacking any sign of granulation tissue (bradytrophic wound bed) * Presence of necrotic tissue * Presence of fistula * History of connective tissue disease, e.g., systemic lupus erythematodes, systemic sclerosis, Sjögren's syndrome or mixed connective tissue disease * Uncontrolled congestive heart failure * Malnutrition (albumin \< 2.5 g/dl; to be measured if clinical signs of malnutrition are being observed) * Uncontrolled diabetes (HbA1c \> 8 %) * Previous organ transplantation * Active malignant disease * Severe rheumatoid arthritis * Undergoing haemodialysis * Active sickle cell disease * Patients who are immunocompromised for reasons such as therapy with corticosteroids, chemotherapy, antiangiogenic or immunosuppressive agents, or due to immunodeficiency syndromes * Pregnant or nursing women * Woman of childbearing potential who are not practicing acceptable methods of birth control during the investigation period * Known allergy to any of the devices' constituents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| 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 | Week 4/8/12 |
| Rate of recurrence of wound at end of follow-up period of 3 months | 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) | Week 12/24 |
Countries
Germany
Outcome results
None listed