Askina Calgitrol Paste Diabetic Foot Ulcers

N/ACompletedNCT01912092

BBraun Medical SAS22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Foot Ulcer (DFU)

Interventions

Askina Calgitrol pasteDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Diabetic Foot and metabolic diseases clinic

Milan, Italy

IRCCS Casa di Cura MultiMedica

Milan, Italy

Outcomes

Primary Outcomes

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.

Time frame: At day 0, day 2 and weekly in a period of a maximum of 6 weeks

Secondary Outcomes

Adverse events or Adverse device related event

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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