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Askina Calgitrol Paste Diabetic Foot Ulcers

Primary Purpose

Diabetic Foot Ulcer (DFU)

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Askina Calgitrol paste
Sponsored by
BBraun Medical SAS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer (DFU)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Diabetic Foot and metabolic diseases clinic
  • IRCCS Casa di Cura MultiMedica

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Askina Calgitrol Paste

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adverse events or Adverse device related event
Evaluation of wound bed (necrosis, slough, granulation, epithelialisation)
It will be assessed visually by the investigator.
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.
Wound surface area
It will be measured by Visitrak Wound Measurement System at each clinic visit by the healthcare professional.

Full Information

First Posted
July 25, 2013
Last Updated
July 30, 2015
Sponsor
BBraun Medical SAS
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1. Study Identification

Unique Protocol Identification Number
NCT01912092
Brief Title
Askina Calgitrol Paste Diabetic Foot Ulcers
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BBraun Medical SAS

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer (DFU)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Askina Calgitrol Paste
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Askina Calgitrol paste
Primary Outcome Measure Information:
Title
Clinical signs of local infection (Presence of erythema, pain, tenderness, warmth or induration)
Description
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 Outcome Measure Information:
Title
Adverse events or Adverse device related event
Time Frame
At day 2 and weekly in a period of a maximum of 6 weeks
Title
Evaluation of wound bed (necrosis, slough, granulation, epithelialisation)
Description
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
Title
Ease of use of Askina Calgitrol Paste
Description
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
Title
Wound surface area
Description
It will be measured by Visitrak Wound Measurement System at each clinic visit by the healthcare professional.
Time Frame
At day 0, day 2 and weekly in a period of a maximum of 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Diabetic Foot and metabolic diseases clinic
City
Milan
Country
Italy
Facility Name
IRCCS Casa di Cura MultiMedica
City
Mila
Country
Italy

12. IPD Sharing Statement

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Askina Calgitrol Paste Diabetic Foot Ulcers

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