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Clinical Trial Summary

The clinical investigation plan will include a Screening/Baseline visit (V1) in which patients will be screened on the basis of inclusion/exclusion criteria and clinically evaluated. Screened and eligible patients will be randomly assigned in one of the two groups: Group 1 will receive ConnettivinaBio Plus cream whereas Group 2 will receive ConnettivinaBio cream. Lesions will be cleaned and a photo will be acquired with a digital camera. In both groups, the schedule treatment will consist of daily medication changes. Wound Bed Score, clinical signs of localized infection, measurement of the wound area, collection of the swab, according to the Levine's technique, EQ-5D questionnaire to the patient will be assessed on Day 1 (V1, baseline visit), 7 (V2), 14 (V3), 21 (V4) and 28 (V5) post-baseline. Treatments in both groups (ConnettivinaBio Plus or ConnettivinaBio) will be applied for a maximum period of 28 days. The easiness of treatment application will be also recorded at V5.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04936204
Study type Interventional
Source Fidia Farmaceutici s.p.a.
Contact Nicola Giordan
Phone +39 049 8232111
Email ngiordan@fidiapharma.it
Status Recruiting
Phase N/A
Start date June 10, 2021
Completion date December 2024

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