Evaluation of Woulgan in Diabetic Foot Ulcer
Phase 4
Completed
- Conditions
- Diabetic Foot Ulcers
- Registration Number
- NCT02631512
- Lead Sponsor
- Biotec Pharmacon ASA
- Brief Summary
The aim of the current study is to support the performance and safety of Woulgan® in the treatment of diabetic foot ulcer in comparison with the commercially available hydrogel Intrasite. Healing and untoward medical events to be evaluated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
Inclusion Criteria
- Type I or II diabetes mellitus.
- Target ulcer area between 0.5 and 5 sqcm, and more than 4 weeks old.
- Ankle-brachial pressure index above 0.7.
Exclusion Criteria
- Ulcers due to non-diabetic etiology.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Performance of Woulgan Gel as primary dressing in diabetic foot ulcer in terms of reduced wound size in sqcm. Until 8 weeks from start of treatment
- Secondary Outcome Measures
Name Time Method Safety of Woulgan Gel as primary dressing in diabetic foot ulcer measured in terms of untoward medical events Until 8 weeks from start of treatment Useability of Woulgan as primary dressing in diabetic foot ulcer measured as degree of pain (100 mm VAS). Until 8 weeks from start of treatment
Trial Locations
- Locations (3)
Skaane University Hospital
🇸🇪Lund, Sweden
North Middlesex University Hospital
🇬🇧London, United Kingdom
Nottingham University Hospital
🇬🇧Nottingham, United Kingdom
Skaane University Hospital🇸🇪Lund, Sweden