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The purpose of this study is to assess the efficacy of Askina® Calgitrol® Paste in reducing local infection in subjects treated for mildly infected Diabetic Foot Ulcers (DFU) with Askina® Calgitrol® Paste.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Askina Calgitrol Paste | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Askina Calgitrol paste | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical signs of local infection (Presence of erythema, pain, tenderness, warmth or induration) | During each of the day 2 and weekly control visits, the investigator will observe the wound visually and assess it for signs of Clinical infection, using the Guidelines for Diabetic Foot Ulcer infection of the Infectious Diseases Society of America. The investigator will score the degree of infection of the wound according to a table adapted from the 8 items wound score for diabetic foot infections. In general, treatment with Askina Calgitrol Paste will be discontinued when local infection has resolved or when it was worsened since the last control visit. However, treatment of Askina Calgitrol Paste will continued after 4 weeks of treatment only if there are signs of improvement. The treatment period of Askina Calgitrol Paste will last a maximum of 6 weeks. | At day 0, day 2 and weekly in a period of a maximum of 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events or Adverse device related event | At day 2 and weekly in a period of a maximum of 6 weeks | |
| Evaluation of wound bed (necrosis, slough, granulation, epithelialisation) | It will be assessed visually by the investigator. |
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Inclusion Criteria:
Subject older than 18 years old
Provision of written consent by the subject themselves
Subjects with a Texas stage I-B wound below the malleolus: superficial and infected (Wagner-Armstrong classification system).
Subjects with a mildly infected wound according to the Infectious Diseases Society of America (IDSA).
Size of wound >2 cm2.
Absence of ischaemia of the lower limb as assessed by :
Capable of following Study instructions.
Compliant with treatment and in particular with off-loading regime.
Stable management of their diabetes as defined by an HbA1C (%) of 12%
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetic Foot and metabolic diseases clinic | Milan | Italy | ||||
| IRCCS Casa di Cura MultiMedica |
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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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| At day 0, day 2 and weekly in a period of a maximum of 6 weeks |
| Ease of use of Askina Calgitrol Paste | Ease of application and removal of dressing will be assessed by the subject/subject's relatives and the investigator using a rating scale of 1 (very easy) to 5 (very difficult). Dressing change at home will be evaluated in a patient diary by the patient or the carer and dressing changes in the clinic by the investigator. | Daily or at every change of dressing, in a period of a maximum of 6 weeks |
| Wound surface area | It will be measured by Visitrak Wound Measurement System at each clinic visit by the healthcare professional. | At day 0, day 2 and weekly in a period of a maximum of 6 weeks |
| Milan |
| Italy |
| 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 |