Status:
COMPLETED
Askina Calgitrol Paste Diabetic Foot Ulcers
Lead Sponsor:
BBraun Medical SAS
Conditions:
Diabetic Foot Ulcer (DFU)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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® P...
Eligibility Criteria
Inclusion
- 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 :
- Transcutaneous oxygen pressure (TcPO2) \> 30 mmHg.
- Toe pressure \> 50 mmHg.
- 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
- Subjects who are \<18 years old.
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01912092
Start Date
April 1 2013
End Date
July 1 2014
Last Update
July 31 2015
Active Locations (2)
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1
Diabetic Foot and metabolic diseases clinic
Milan, Italy
2
IRCCS Casa di Cura MultiMedica
Milan, Italy