Use of Fish Skin Extracellular Matrix (ECM) to Facilitate Chronic Wound Healing
Not Applicable
Completed
- Conditions
- Diabetic UlcersChronic Ulcer of FootPressure UlcersVenous UlcersTrauma-related Wound
- Interventions
- Device: Marigen Wound Dressing
- Registration Number
- NCT01348581
- Lead Sponsor
- Kerecis Ltd.
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Marigen Wound Dressing Marigen Wound Dressing -
- Primary Outcome Measures
Name Time Method Wound healing one year
- Secondary Outcome Measures
Name Time Method Wound granulation one year
Trial Locations
- Locations (1)
National University Hospital
🇮🇸Reykjavik, Iceland