NCT00998673

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2009

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 20, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 14, 2015

Status Verified

July 1, 2015

Enrollment Period

2.2 years

First QC Date

October 2, 2009

Last Update Submit

July 13, 2015

Conditions

Venous Ulcer

Keywords

Silica gel fiberChronic venous leg ulcersVenous ulcerStasis ulcerVaricose ulcer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

Arm 1

EXPERIMENTAL
Device: Silica Gel Fiber

Arm 2

OTHER
Device: Standard-of-Care

Interventions

Silica Gel FiberDEVICE

Silica Gel Fiber (SGF) applications as required

Arm 1
Standard-of-CareDEVICE

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

Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Treatment with active wound care agents paused for 14 days before start of study treatment

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Berlin, 10827, Germany

Location

Unknown Facility

Bochum, 44791, Germany

Location

Unknown Facility

Bonn, 53105, Germany

Location

Unknown Facility

Cologne, 50937, Germany

Location

Unknown Facility

Dresden, 01067, Germany

Location

Unknown Facility

Essen, 45147, Germany

Location

Unknown Facility

Frankfurt, 60590, Germany

Location

Unknown Facility

Freiburg im Breisgau, 79100, Germany

Location

Unknown Facility

Göttingen, 37075, Germany

Location

Unknown Facility

Greifswald, 17487, Germany

Location

Unknown Facility

Hamburg, 20246, Germany

Location

Unknown Facility

Mannheim, 68163, Germany

Location

Unknown Facility

Regensburg, 93053, Germany

Location

Unknown Facility

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2009

First Posted

October 20, 2009

Study Start

April 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

July 14, 2015

Record last verified: 2015-07

Locations

DE(14)