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

Pressure Ulcers Clinical Trial

Official title:

Chronic Wound Treatment With Extracellular Matrix (ECM) Scaffold Made From Fish Proteins

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01348581
• Other study ID #: KERECIS-10-106-S1
• Secondary ID: MW-ECM
• Status: Completed
• Phase: N/A
• First received: May 4, 2011
• Last updated: February 28, 2017
• Start date: November 2010
• Est. completion date: January 1, 2013

Study information

• Verified date: May 2011
• Source: Kerecis Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 1, 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Ulcer of Foot
• Diabetic Ulcers
• Foot Ulcer
• Pressure Ulcer
• Pressure Ulcers
• Trauma-related Wound
• Ulcer
• Varicose Ulcer
• Venous Ulcers
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Iceland	National University Hospital	Reykjavik

Sponsors (1)

Lead Sponsor	Collaborator
Kerecis Ltd.

Country where clinical trial is conducted

Iceland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing		one year
Secondary	Wound granulation		one year