Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
62 participants
INTERVENTIONAL
2015-10-31
2019-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Woulgan Gel
Primary dressing with Woulgan Gel with Soluble Beta-Glucan (SBG)
Woulgan Gel
Primary dressing gel to be applied to the wound bed, and to be covered with a secondary bandage.
Intrasite Hydrogel
Primary dressing with Intrasite Hydrogel
Intrasite Hydrogel
Primary dressing hydrogel to be applied to the wound bed, and to be covered with a secondary bandage
Interventions
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Woulgan Gel
Primary dressing gel to be applied to the wound bed, and to be covered with a secondary bandage.
Intrasite Hydrogel
Primary dressing hydrogel to be applied to the wound bed, and to be covered with a secondary bandage
Eligibility Criteria
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Inclusion Criteria
* Target ulcer area between 0.5 and 5 sqcm, and more than 4 weeks old.
* Ankle-brachial pressure index above 0.7.
Exclusion Criteria
* Uncontrolled diabetes defined as HbA1c above 70 mmol/mol and insufficient nutritional status.
* Ulcers older than 1 year.
* Any of gangrene, osteomyelitis, cellulitis, or Charcot osteoarthropathy.
18 Years
ALL
No
Sponsors
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Biotec Pharmacon ASA
INDUSTRY
Responsible Party
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Principal Investigators
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Magnus Londahl, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Skane University Hospital
Locations
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Skaane University Hospital
Lund, , Sweden
North Middlesex University Hospital
London, , United Kingdom
Nottingham University Hospital
Nottingham, , United Kingdom
Countries
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Other Identifiers
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WBG-03
Identifier Type: -
Identifier Source: org_study_id
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