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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Kerecis Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kerecis Ltd.
ClinicalTrials.gov Identifier:
NCT01348581
First received: May 4, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted

May 4, 2011
May 4, 2011
November 2010
October 2011   (final data collection date for primary outcome measure)
Wound healing [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Wound granulation [ Time Frame: one year ] [ Designated as safety issue: Yes ]
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
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Recruiting
10
Not Provided
October 2011   (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
Both
18 Years and older
No
Contact: Baldur T Baldursson, MD, PhD +354-543-6350 baldurb@landspitali.is
Iceland
 
NCT01348581
KERECIS-10-106-S1, MW-ECM
Yes
Dr. Baldur T. Baldursson/Consultant, National University Hospital of Iceland
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