Diabetic Foot Ulcers
Conditions
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.
Interventions
DEVICEWoulgan Gel
Primary dressing gel to be applied to the wound bed, and to be covered with a secondary bandage.
DEVICEIntrasite Hydrogel
Primary dressing hydrogel to be applied to the wound bed, and to be covered with a secondary bandage
Sponsors
Biotec Pharmacon ASA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Sweden, United Kingdom
Outcome results
None listed