Silica Gel Fiber Wound Dressing for Chronic Venous Leg Ulcers

Venous Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00998673
• Other study ID #: SGF271-01
• Status: Terminated
• Phase: Phase 2
• First received: October 2, 2009
• Last updated: July 13, 2015
• Start date: April 2009
• Est. completion date: June 2011

Study information

• Verified date: July 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 121
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Ulcer

Intervention

Device:
• Silica Gel Fiber
Silica Gel Fiber (SGF) applications as required
• Standard-of-Care
Standard-of-Care with dressing changes twice per week using Mepitel and Mepilex wound dressings

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Rate of recurrence of wound at end of follow-up period of 3 months		Week 24	No
Secondary	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	No

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