Askina Calgitrol Paste Diabetic Foot Ulcers

Diabetic Foot Ulcer (DFU) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912092
• Other study ID #: OPM-O-H-1205
• Status: Completed
• Phase: N/A
• First received: July 25, 2013
• Last updated: July 30, 2015
• Start date: April 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2015
• Source: BBraun Medical SAS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer (DFU)
• Foot Ulcer
• Ulcer

Intervention

Device:
• Askina Calgitrol paste

Locations

Country	Name	City	State
Italy	IRCCS Casa di Cura MultiMedica	Mila
Italy	Diabetic Foot and metabolic diseases clinic	Milan

Sponsors (1)

Lead Sponsor	Collaborator
BBraun Medical SAS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Adverse events or Adverse device related event		At day 2 and weekly in a period of a maximum of 6 weeks	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No