NCT01348581

Brief Summary

The clinical study is designed to assess the effectiveness, safety and non-immunogenicity of fish skin wound dressing extracellular matrix (ECM) in treating chronic wounds. The wound dressing is indicated for the management of difficult to heal and chronic wounds. The matrix is cut to fit the wound and is applied to the wound bed. An absorptive secondary dressing is put on top. Further dressing of the wound depends on the etiology. The indications for use are:

  • partial and full-thickness wounds
  • pressure ulcers
  • venous ulcers
  • diabetic ulcers
  • chronic vascular ulcers
  • tunneled/undermined wounds
  • trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

March 3, 2017

Status Verified

May 1, 2011

Enrollment Period

2.1 years

First QC Date

May 4, 2011

Last Update Submit

February 28, 2017

Conditions

Pressure UlcersVenous UlcersDiabetic UlcersChronic Ulcer of FootTrauma-related Wound

Keywords

AdultAgedAged, 80 and overBandagesBiological DressingsChronic DiseaseCollagenEpitheliumExtracellular MatrixFibroblastsGranulation TissueHumansLeg UlcerMiddle AgedProspective StudiesSoft Tissue InjuriesTreatment OutcomeVaricose UlcerWound HealingWounds and Injuries

Outcome Measures

Primary Outcomes (1)

  • Wound healing

    one year

Secondary Outcomes (1)

  • Wound granulation

    one year

Study Arms (1)

Marigen Wound Dressing

EXPERIMENTAL
Device: Marigen Wound Dressing

Interventions

Marigen Wound DressingDEVICE

The dressing is changed at least twice a week, with no more than five days between dressing changes. It is extremely important that the dressings are changed sufficiently often. On highly exuding ulcers the three or four dressing changes per week may be necessary. Duration is four weeks.

Marigen Wound Dressing

Eligibility Criteria

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

You may qualify if:

  • Venous leg ulcer
  • Arterial leg ulcer
  • Rheumatic leg ulcer
  • Hydrostatic leg ulcer
  • Ulcer where healing is delayed because of drug therapy
  • Non-healing ulcer due to known or unknown causes

You may not qualify if:

  • Active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Reykjavik, 108, Iceland

Location

MeSH Terms

Conditions

Pressure UlcerVaricose UlcerChronic DiseaseLeg UlcerSoft Tissue InjuriesWounds and Injuries

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue DiseasesVaricose VeinsVascular DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2011

First Posted

May 5, 2011

Study Start

November 1, 2010

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

March 3, 2017

Record last verified: 2011-05

Locations

IC(1)