Askina Calgitrol Paste Diabetic Foot Ulcers

Study Overview
=================
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® Paste.

Official Title
-----------------
A NON-CONTROLLED PROSPECTIVE COHORT STUDY OF THE USE OF ASKINA® CALGITROL® PASTE + STANDARD OF CARE ON MILDLY INFECTED, NON-ISCHAEMIC DIABETIC FOOT ULCERS

Conditions
-----------------
Diabetic Foot Ulcer (DFU)

Intervention / Treatment
-----------------
* Device: Askina Calgitrol paste


Participation Criteria
=================
Eligibility Criteria
-----------------
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 : 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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Askina Calgitrol Paste<br> | Device: Askina Calgitrol paste<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |