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Use of Fish Skin Extracellular Matrix (ECM) to Facilitate Chronic Wound Healing

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01348581
First Posted: May 5, 2011
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kerecis Ltd.
May 4, 2011
May 5, 2011
March 3, 2017
November 2010
December 2012   (Final data collection date for primary outcome measure)
Wound healing [ Time Frame: one year ]
Same as current
Complete list of historical versions of study NCT01348581 on ClinicalTrials.gov Archive Site
Wound granulation [ Time Frame: one year ]
Same as current
Not Provided
Not Provided
 
Use of Fish Skin Extracellular Matrix (ECM) to Facilitate Chronic Wound Healing
Chronic Wound Treatment With Extracellular Matrix (ECM) Scaffold Made From Fish Proteins

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)
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pressure Ulcers
  • Venous Ulcers
  • Diabetic Ulcers
  • Chronic Ulcer of Foot
  • Trauma-related Wound
Device: Marigen Wound Dressing
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.
Experimental: Marigen Wound Dressing
Intervention: Device: Marigen Wound Dressing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
January 1, 2013
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Active infection
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Iceland
 
 
NCT01348581
KERECIS-10-106-S1
MW-ECM
Yes
Not Provided
Not Provided
Kerecis Ltd.
Kerecis Ltd.
Not Provided
Not Provided
Kerecis Ltd.
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP