NCT01912092

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

1.2 years

First QC Date

July 25, 2013

Last Update Submit

July 30, 2015

Conditions

Diabetic Foot Ulcer (DFU)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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)

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

  • Ease of use of Askina Calgitrol Paste

    Daily or at every change of dressing, in a period of a maximum of 6 weeks

  • Wound surface area

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

Study Arms (1)

Askina Calgitrol Paste

EXPERIMENTAL
Device: Askina Calgitrol paste

Interventions

Askina Calgitrol pasteDEVICE
Askina Calgitrol Paste

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Diabetic Foot and metabolic diseases clinic

Milan, Italy

Location

IRCCS Casa di Cura MultiMedica

Milan, Italy

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2013

First Posted

July 30, 2013

Study Start

April 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations

IT(2)