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
NA
22 participants
INTERVENTIONAL
2013-04-30
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Askina Calgitrol Paste
Askina Calgitrol paste
Interventions
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Askina Calgitrol paste
Eligibility Criteria
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Inclusion Criteria
* 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 :
1. Transcutaneous oxygen pressure (TcPO2) \> 30 mmHg.
2. Toe pressure \> 50 mmHg.
3. Ankle pressure \> 70 mmHg.
* 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
* Subjects with a documented sensitivity to alginates or silver.
* Subjects taking a medication or using a device comprising silver.
* Subjects already taking antibiotics before enrolment
* Subjects undergoing dialysis.
* Subjects using therapy known to be immune-compromising such as systemic anti-neoplastic drugs and/or systemic cortico-steriods.
* Pregnancy
* Breast-feeding
* Currently participating in another clinical trial, or who have participated in another clinical trial in the last 6 weeks or who have previously taken part in this study
18 Years
ALL
No
Sponsors
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BBraun Medical SAS
INDUSTRY
Responsible Party
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Locations
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Diabetic Foot and metabolic diseases clinic
Milan, , Italy
IRCCS Casa di Cura MultiMedica
Milan, , Italy
Countries
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Other Identifiers
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OPM-O-H-1205
Identifier Type: -
Identifier Source: org_study_id