Use of Fish Skin Extracellular Matrix (ECM) to Facilitate... | NCT01348581

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

NCT01348581

Sponsor

Kerecis Ltd.

Status

Completed

Last Update Posted

Mar 3, 2017Actual

Enrollment

37Actual

Phase

Not Applicable

Conditions

Pressure Ulcers
Venous Ulcers
Diabetic Ulcers
Chronic Ulcer of Foot
Trauma-related Wound

Interventions

Marigen Wound Dressing

Countries

Iceland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
MW-ECM

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Dec 2012Actual

Completion Date

Jan 1, 2013Actual

First Submitted Date

May 4, 2011

First Submission Date that Met QC Criteria

May 4, 2011

First Posted Date

May 5, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2017

Last Update Posted Date

Mar 3, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

Not provided

Conditions Module

Conditions

Pressure Ulcers
Venous Ulcers
Diabetic Ulcers
Chronic Ulcer of Foot
Trauma-related Wound

Keywords

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Marigen Wound Dressing	Experimental		Device: Marigen Wound Dressing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Marigen Wound Dressing	Device	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.

Measure	Description	Time Frame
Wound healing		one year

Measure	Description	Time Frame
Wound granulation		one year

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National University Hospital		Reykjavik		108	Iceland

Condition Browse Module

MeSH Terms

ID	Term
D003668	Pressure Ulcer
D014647	Varicose Ulcer
D002908	Chronic Disease
D007871	Leg Ulcer
D017695	Soft Tissue Injuries
D014947	Wounds and Injuries

Ancestor Terms

ID	Term
D012883	Skin Ulcer
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D014648	Varicose Veins

Browse Leaves

Not provided

Browse Branches

Not provided