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Completed

NCT Number: NCT01348581

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

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)

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Key information

Conditions

Pressure Ulcers Cardiovascular Diseases Chronic Disease Chronic Ulcer of Foot Diabetic Ulcers Disease Attributes Leg Ulcer Pathologic Processes Pathological Conditions, Signs and Symptoms Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Soft Tissue Injuries Trauma-related Wound Varicose Ulcer Varicose Veins Vascular Diseases Venous Ulcers Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University Hospital

Reykjavik, 108, Iceland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Wound healing

    Time frame: one year

Secondary outcomes

  1. Wound granulation

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Kerecis Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
May 5, 2011
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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