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Venous UlcerPhase 2NCT00998673

Silica Gel Fiber Wound Dressing for Chronic Venous Leg Ulcers

A Phase 2 study testing Silica Gel Fiber and Standard-of-Care in people with Venous Ulcer, run by Bayer at 14 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Ulcer
What is being tested?
Silica Gel Fiber and Standard-of-Care
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
14 sitesGermany
Study dates
Apr 2009to Jun 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Germany14 sites

  • Study site

    Berlin, 10827

  • Study site

    Bochum, 44791

  • Study site

    Bonn, 53105

  • Study site

    Cologne, 50937

  • Study site

    Dresden, 01067

  • Study site

    Essen, 45147

  • Study site

    Frankfurt, 60590

  • Study site

    Freiburg im Breisgau, 79100

  • Study site

    Göttingen, 37075

  • Study site

    Greifswald, 17487

  • Study site

    Hamburg, 20246

  • Study site

    Mannheim, 68163

  • Study site

    Regensburg, 93053

  • Study site

    Ulm, 89081

Other trials in Germany

About this study

Official title: 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.

Conditions
Venous Ulcer
Being tested
Silica Gel Fiber, Standard-of-Care
Keywords
Silica gel fiber, Chronic venous leg ulcers, Venous ulcer, Stasis ulcer, Varicose ulcer
Medical subject headings
Varicose Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Silica Gel FiberDevice

    Silica Gel Fiber (SGF) applications as required

  • Standard-of-CareDevice

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

Study groups in NCT00998673
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Device: Silica Gel Fiber
Arm 2OtherNot described
Receives: Device: Standard-of-Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Week 12

Secondary outcomes (3)

  1. 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

    Measured: Week 4/8/12

  2. Rate of recurrence of wound at end of follow-up period of 3 months

    Measured: Week 24

  3. 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)

    Measured: Week 12/24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00998673
Sponsor's protocol ID
SGF271-01
Status last verified
Jul 2015
First submitted
2 Oct 2009
Last updated
14 Jul 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Silica Gel Fiber and Standard-of-Care in people with Venous Ulcer, run by Bayer at 14 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00998673.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2015.

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