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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
  Purpose

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)

Condition Intervention
Pressure Ulcers
Venous Ulcers
Diabetic Ulcers
Chronic Ulcer of Foot
Trauma-related Wound
 Device: Marigen Wound Dressing

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Chronic Wound Treatment With Extracellular Matrix (ECM) Scaffold Made From Fish Proteins

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kerecis Ltd.:

Primary Outcome Measures:
  • Wound healing [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Wound granulation [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: November 2010
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Marigen Wound Dressing 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348581

Contacts
Contact: Baldur T Baldursson, MD, PhD +354-543-6350 baldurb@landspitali.is

Locations
Iceland
National University Hospital Recruiting
Reykjavik, Iceland, 108
Contact: Baldur T Baldursson, MD, PhD     +354-543-6350     baldurb@landspitali.is    
Principal Investigator: Baldur T Baldursson, MD, Phd            
Sponsors and Collaborators
Kerecis Ltd.
  More Information

No publications provided

Responsible Party: Dr. Baldur T. Baldursson/Consultant, National University Hospital of Iceland
ClinicalTrials.gov Identifier: NCT01348581     History of Changes
Other Study ID Numbers: KERECIS-10-106-S1, MW-ECM
Study First Received: May 4, 2011
Last Updated: May 4, 2011
Health Authority: Iceland: Ministry of Health and Social Security

Keywords provided by Kerecis Ltd.:
Adult
Aged
Aged, 80 and over
Bandages
Biological Dressings
Chronic Disease
Collagen
Epithelium
Extracellular Matrix
Fibroblasts
 Granulation Tissue
Humans
Leg Ulcer
Middle Aged
Prospective Studies
Soft Tissue Injuries
Treatment Outcome
Varicose Ulcer
Wound Healing
Wounds and Injuries

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Varicose Ulcer
Foot Ulcer
Skin Ulcer
Skin Diseases
 Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Foot Diseases

ClinicalTrials.gov processed this record on May 16, 2013