Askina Calgitrol Paste Diabetic Foot Ulcers

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

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 Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer (DFU)
• Intervention / Treatment: Device: Askina Calgitrol paste

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Mila, Italy
    • IRCCS Casa di Cura MultiMedica
  • Milan, Italy
    • Diabetic Foot and metabolic diseases clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Askina Calgitrol Paste	Device: Askina Calgitrol paste

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

Collaborators and Investigators

• Sponsor: BBraun Medical SAS

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: July 25, 2013
• First Submitted That Met QC Criteria: July 29, 2013
• First Posted (Estimate): July 30, 2013

Study Record Updates

• Last Update Posted (Estimate): July 31, 2015
• Last Update Submitted That Met QC Criteria: July 30, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: OPM-O-H-1205