An interventional study of Askina Calgitrol paste in Diabetic Foot Ulcer (DFU), sponsored by BBraun Medical SAS. Completed at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-31.
Sponsored by BBraun Medical SAS · Not applicable, Interventional, and Treatment
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 22 is below the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →BBraun Medical SAS is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Absence of ischaemia of the lower limb as assessed by :
Exclusion Criteria:
Device: Askina Calgitrol paste
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.
Time frame: At day 0, day 2 and weekly in a period of a maximum of 6 weeks
Adverse events or Adverse device related event
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At day 0, day 2 and weekly in a period of a maximum of 6 weeks
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
BBraun Medical SAS