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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Woulgan Gel | Other | Primary dressing with Woulgan Gel with Soluble Beta-Glucan (SBG) |
|
| Intrasite Hydrogel | Other | Primary dressing with Intrasite Hydrogel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Woulgan Gel | Device | Primary dressing gel to be applied to the wound bed, and to be covered with a secondary bandage. |
|
| Measure | Description | 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 |
| Measure | Description | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magnus Londahl, MD, PhD | Skane University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skaane University Hospital | Lund | S-22185 | Sweden | |||
| North Middlesex University Hospital |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| Intrasite Hydrogel | Device | Primary dressing hydrogel to be applied to the wound bed, and to be covered with a secondary bandage |
|
| Until 8 weeks from start of treatment |
| London |
| N18 1QX |
| United Kingdom |
| Nottingham University Hospital | Nottingham | NG72UH | United Kingdom |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |