Clinical trial NCT00998673: Silica Gel Fiber Wound Dressing for Chronic Venous Leg Ulcers
Official title: Randomized Standard-of-Care-Controlled Trial of a Silica Gel Fiber (SGF) Wound Dressing in the Treatment of Chronic Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Venous Ulcer
Keywords: Silica gel fiber
Chronic venous leg ulcers
Venous ulcer
Stasis ulcer
Varicose ulcer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-10-20
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Week 12
Secondary outcomes:
measure: 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
timeFrame: Week 4/8/12
measure: Rate of recurrence of wound at end of follow-up period of 3 months
timeFrame: Week 24
measure: 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)
timeFrame: Week 12/24
Other outcomes:
Locations:
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Bonn
country: Germany
city: Dresden
country: Germany
city: Essen
country: Germany
city: Frankfurt
country: Germany
city: Freiburg
country: Germany
city: Greifswald
country: Germany
city: Göttingen
country: Germany
city: Hamburg
country: Germany
city: Köln
country: Germany
city: Mannheim
country: Germany
city: Regensburg
country: Germany
city: Ulm
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: