Silica Gel Fiber Wound Dressing for Chronic Venous Leg Ulcers

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Standard-of-Care-Controlled Trial of a Silica Gel Fiber (SGF) Wound Dressing in the Treatment of Chronic Venous Leg Ulcers

Conditions
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Venous Ulcer

Intervention / Treatment
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* Device: Silica Gel Fiber
* Device: Standard-of-Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Device: Silica Gel Fiber<br>* Silica Gel Fiber (SGF) applications as required<br>|
| Other: Arm 2<br> | Device: Standard-of-Care<br>* Standard-of-Care with dressing changes twice per week using Mepitel and Mepilex wound dressings<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Silica gel fiber, Chronic venous leg ulcers, Venous ulcer, Stasis ulcer, Varicose ulcer