{"id":8319,"date":"2023-07-04T12:02:09","date_gmt":"2023-07-04T10:02:09","guid":{"rendered":"https:\/\/www.icta.fr\/?post_type=casclients&p=8319"},"modified":"2026-01-14T10:22:57","modified_gmt":"2026-01-14T09:22:57","slug":"pain-relief-and-protection-of-three-self-treated-dermatological-foot-conditions","status":"publish","type":"casclients","link":"https:\/\/www.icta.fr\/fr\/cas-clients\/pain-relief-and-protection-of-three-self-treated-dermatological-foot-conditions\/","title":{"rendered":"Pain relief and protection of three self-treated dermatological foot conditions"},"content":{"rendered":"\n
<\/div>
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OBJECTIVES<\/h3>\n\n\n\n
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PRIMARY OBJECTIVE<\/h4>\n\n\n\n

<\/p>\n\n\n\n

    \n
  • Instant pain\/discomfort relief<\/li>\n<\/ul>\n<\/div>\n\n\n\n
    \n

    SECONDARY OBJECTIVES<\/h4>\n\n\n\n

    <\/p>\n\n\n\n

      \n
    • Pain\/discomfort relief<\/li>\n\n\n\n
    • Pressure relief<\/li>\n\n\n\n
    • Duration<\/li>\n\n\n\n
    • Softening<\/li>\n\n\n\n
    • Prevention of condition worsening<\/li>\n\n\n\n
    • Cushioning<\/li>\n\n\n\n
    • Adhesion<\/li>\n\n\n\n
    • Usability<\/li>\n\n\n\n
    • Global perception\/satisfaction<\/li>\n\n\n\n
    • Safety<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n
      \n
      \n

      SCIENTIFIC and DATA vALORISATION<\/h3>\n\n\n\n
        \n
      • 1 Clinical Study Report (ISO14155:2020 template)<\/li>\n\n\n\n
      • 3 Clinical Evaluation Report (CER) updates performed by another provider (CER are key reports to update each product CE marking dossier)<\/em><\/li>\n\n\n\n
      • 1 Scientific publication ongoing Q2 2023<\/li>\n\n\n\n
      • Overall excellent client satisfaction, acknowledgment and trust<\/li>\n<\/ul>\n<\/div>\n\n\n\n
        \n

        Key factors of success<\/strong><\/h3>\n\n\n\n
          \n
        • ICTA\u2019s expertise in methodology\/study design<\/li>\n\n\n\n
        • ICTA\u2019s capability to propose innovative solutions for unusual projects<\/li>\n\n\n\n
        • ICTA\u2019s responsiveness and flexibility<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n
          \n
          \n

          LESSONS LEARNED to speed up the start-up phase of the next study<\/h3>\n\n\n\n
            \n
          • Adaptability: Learn to work and communicate with a Sponsor who has a marketing-based culture rather than a scientific-based one<\/li>\n\n\n\n
          • Optimal project coordination: Reporting tools implementation, community pharmacies management<\/li>\n\n\n\n
          • Learn to communicate and coordinate investigators not experienced with clinical investigations<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n

            CHALLENGES<\/h3>\n\n\n\n
            KEY CHALLENGES<\/th>ICTA’s SOLUTIONS<\/th>ICTA’s ACHIEVEMENTS<\/th><\/tr><\/thead>
            Compliance with MDR requirements and Sponsor requirements to collect data useful for each of their product Clinical Evaluation Report (CER)<\/strong><\/td>Study documents prepared based on ISO14155 guidelines
             
            Focus on several products and claims to provide valid and reliable data to Sponsor (see below)<\/td>            		Preparation of study document templates based on ISO14155:2020
             
            1 CSR and 3 CER<\/td><\/tr>
            Sponsors\u2019 multiple requests during kick-off meeting, e.g.:<\/strong>
            \u00b7  Three studied medical conditions<\/strong>
            \u00b7  Numerous objectives\/endpoints to address multiple claims<\/strong>
            \u00b7  Several products to test<\/strong>
            \u00b7  Need for individual results per product<\/strong>
            Specific subpopulations <\/strong>(elderly, pregnant\/breastfeeding, controlled diabetes)\u2026<\/td>            		Appropriate non-interventional study design and methodology to address all Sponsor\u2019s requests while keeping in mind the study feasibility in the context of the COVID-19 pandemic and vaccination period and type of targeted populations<\/td>Design and development of a real-life settings study, and homemade questionnaires to assess relevant claims<\/td><\/tr>
            Non-serious self-treated medical conditions rarely leading in a medical consultation but regulatory requirements to have qualified investigators<\/strong><\/td>. Decision to involve pharmacies as studied medical conditions are self-treated by over-the-counter products
            . Use of structured networks also widespread on the territory
            . Specific targeting of pharmacies selling as routine care at least one of the medical devices<\/td>            		. Among 6,000 potential pharmacies identified, selection of best candidates for participation to study:
            . 124 pharmacies in Metropolitan France signed contract and 36 enrolled at least one patient<\/td><\/tr>
            Patient recruitment: Fieldwork during COVID-19 vaccination during which community pharmacies were actively involved<\/strong><\/td>. Reduced study burden to facilitate contracting, enrolment and data collection procedures.
            . Remote study training of pharmacies adapted to pharmacists timetable.
            . Increased number of sites, sites contacts, incentives
            Extended timelines.<\/td>            		. The planned sample size (of 1,232 patients) was not reached: 417 patients were included but precision of primary endpoint was acceptable after analysis (6-11%).<\/td><\/tr>
            Real-life data collection<\/strong><\/td>. Use of easy to complete electronic CRF for pharmacists focused on a very limited number of key data
            . Use of dedicated paper patient questionnaire to facilitate patient data collection over follow-up
            . Planned reminders by pharmacists to contact their enrolled patients and retrieve completed patient questionnaires in order to increase study quality and robustness<\/td>            		. Close contact with active pharmacies leading to active engagement.
            . Elevated response rate (questionnaire completion) over a 20-days follow-up period.
            . High compliance to questionnaire completion: 96.7%-100.0% of patients completed questionnaires over the 20-days follow-up period.
            . Collection of robust data.<\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div><\/section>\n\n\n\n
              \n
            • <\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":15,"featured_media":10773,"template":"","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","inline_featured_image":false,"_uag_custom_page_level_css":"","kk_blocks_editor_width":"","_kiokenblocks_attr":"","_kiokenblocks_dimensions":"","footnotes":""},"categories":[],"class_list":["post-8319","casclients","type-casclients","status-publish","has-post-thumbnail","hentry"],"acf":[],"uagb_featured_image_src":{"full":["https:\/\/www.icta.fr\/wp-content\/uploads\/foot-dermatological.jpg",480,240,false],"thumbnail":["https:\/\/www.icta.fr\/wp-content\/uploads\/foot-dermatological-128x88.jpg",128,88,true],"medium":["https:\/\/www.icta.fr\/wp-content\/uploads\/foot-dermatological-300x150.jpg",300,150,true],"medium_large":["https:\/\/www.icta.fr\/wp-content\/uploads\/foot-dermatological.jpg",480,240,false],"large":["https:\/\/www.icta.fr\/wp-content\/uploads\/foot-dermatological.jpg",480,240,false],"1536x1536":["https:\/\/www.icta.fr\/wp-content\/uploads\/foot-dermatological.jpg",480,240,false],"2048x2048":["https:\/\/www.icta.fr\/wp-content\/uploads\/foot-dermatological.jpg",480,240,false],"post-thumbnail":["https:\/\/www.icta.fr\/wp-content\/uploads\/foot-dermatological.jpg",480,240,false],"wpm_taille_1":["https:\/\/www.icta.fr\/wp-content\/uploads\/foot-dermatological-364x240.jpg",364,240,true],"wpm_taille_slider":["https:\/\/www.icta.fr\/wp-content\/uploads\/foot-dermatological-240x145.jpg",240,145,true],"gform-image-choice-sm":["https:\/\/www.icta.fr\/wp-content\/uploads\/foot-dermatological.jpg",300,150,false],"gform-image-choice-md":["https:\/\/www.icta.fr\/wp-content\/uploads\/foot-dermatological.jpg",400,200,false],"gform-image-choice-lg":["https:\/\/www.icta.fr\/wp-content\/uploads\/foot-dermatological.jpg",480,240,false]},"uagb_author_info":{"display_name":"Manon ROBERT","author_link":"https:\/\/www.icta.fr\/fr\/author\/mrobert-icta21\/"},"uagb_comment_info":0,"uagb_excerpt":null,"_links":{"self":[{"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/casclients\/8319","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/casclients"}],"about":[{"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/types\/casclients"}],"author":[{"embeddable":true,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/users\/15"}],"version-history":[{"count":14,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/casclients\/8319\/revisions"}],"predecessor-version":[{"id":8628,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/casclients\/8319\/revisions\/8628"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/media\/10773"}],"wp:attachment":[{"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/media?parent=8319"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/categories?post=8319"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}