Silica Gel Fiber Wound Dressing for Chronic Venous Leg Ulcers

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

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 Overview

• Status: Terminated
• Conditions: Venous Ulcer
• Intervention / Treatment: Device: Silica Gel Fiber; Device: Standard-of-Care

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10827
  • Bochum, Germany, 44791
  • Bonn, Germany, 53105
  • Dresden, Germany, 01067
  • Essen, Germany, 45147
  • Frankfurt, Germany, 60590
  • Freiburg, Germany, 79100
  • Greifswald, Germany, 17487
  • Göttingen, Germany, 37075
  • Hamburg, Germany, 20246
  • Köln, Germany, 50937
  • Mannheim, Germany, 68163
  • Regensburg, Germany, 93053
  • Ulm, Germany, 89081

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: October 2, 2009
• First Submitted That Met QC Criteria: October 19, 2009
• First Posted (Estimate): October 20, 2009

Study Record Updates

• Last Update Posted (Estimate): July 14, 2015
• Last Update Submitted That Met QC Criteria: July 13, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Chronic venous leg ulcers; Venous ulcer; Stasis ulcer; Varicose ulcer; Silica gel fiber
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: SGF271-01