Silica Gel Fiber Wound Dressing for Chronic Venous Leg Ulcers

NCT ID: NCT00998673

Last Updated: 2015-07-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2011-06-30

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.

Conditions

Venous Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Silica Gel Fiber

Intervention Type: DEVICE

Silica Gel Fiber (SGF) applications as required

Arm 2

Group Type: OTHER

Standard-of-Care

Intervention Type: DEVICE

Standard-of-Care with dressing changes twice per week using Mepitel and Mepilex wound dressings

Interventions

Silica Gel Fiber

Silica Gel Fiber (SGF) applications as required

Intervention Type: DEVICE

Standard-of-Care

Standard-of-Care with dressing changes twice per week using Mepitel and Mepilex wound dressings

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Berlin, , Germany

Bochum, , Germany

Bonn, , Germany

Cologne, , Germany

Dresden, , Germany

Essen, , Germany

Frankfurt, , Germany

Freiburg im Breisgau, , Germany

Göttingen, , Germany

Greifswald, , Germany

Hamburg, , Germany

Mannheim, , Germany

Regensburg, , Germany

Ulm, , Germany

Countries

Germany

Other Identifiers

SGF271-01

Identifier Type: -

Identifier Source: org_study_id