Askina Calgitrol Paste Diabetic Foot Ulcers

B. Braun

Status

Completed

Conditions

Diabetic Foot Ulcer (DFU)

Treatments

Device: Askina Calgitrol paste

Study type

Interventional

Funder types

Industry

Identifiers

NCT01912092

OPM-O-H-1205

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 :
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 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