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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01348581

Enrollment

Registered

2011-05-05

Start date

2010-11-30

Completion date

2013-01-01

Last updated

2017-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

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)

Interventions

DEVICEMarigen 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Wound healing	one year

Secondary

Measure	Time frame
Wound granulation	one year

Countries

Iceland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026