{"id":7874,"date":"2023-06-14T16:02:36","date_gmt":"2023-06-14T14:02:36","guid":{"rendered":"https:\/\/www.icta.fr\/cas-clients\/prevention-treatment-of-a-non-serious-dermatological-condition-on-the-foot\/"},"modified":"2026-01-14T10:14:51","modified_gmt":"2026-01-14T09:14:51","slug":"prevention-treatment-of-a-non-serious-dermatological-condition-on-the-foot","status":"publish","type":"casclients","link":"https:\/\/www.icta.fr\/fr\/cas-clients\/prevention-treatment-of-a-non-serious-dermatological-condition-on-the-foot\/","title":{"rendered":"Prevention & Treatment of a non-serious dermatological condition on the foot"},"content":{"rendered":"\n
<\/div>
\n

OBJECTIVES<\/h3>\n\n\n\n
\n
\n

PRIMARY OBJECTIVES<\/h4>\n\n\n\n

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

    \n
  • Preventive study: Prevention<\/li>\n\n\n\n
  • Curative study: Instant pain relief<\/li>\n<\/ul>\n\n\n\n

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

    \n

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

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

      \n
    • Preventive study\n
        \n
      • Plaster adhesion & rubbing off<\/li>\n\n\n\n
      • Duration of use<\/li>\n\n\n\n
      • Usability (only for hydrocolloid plasters)<\/li>\n\n\n\n
      • Global perception\/satisfaction<\/li>\n\n\n\n
      • Safety (only for hydrocolloid plasters)<\/li>\n<\/ul>\n<\/li>\n\n\n\n
      • Curative study\n
          \n
        • Pain relief evolution<\/li>\n\n\n\n
        • Pressure relief<\/li>\n\n\n\n
        • Duration<\/li>\n\n\n\n
        • Time to Healing<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n
          \n
          \n

          SCIENTIFIC and DATA VALORISATION<\/h3>\n\n\n\n
            \n
          • 2 Clinical Study Reports (ISO14155:2020 template)<\/li>\n\n\n\n
          • 4 Clinical Evaluation Reports (CER) updates performed by another provider (CER are key reports to update each product CE marking dossier)<\/em><\/li>\n\n\n\n
          • 2 Scientific publications ongoing Q1 2023<\/li>\n\n\n\n
          • 1 Scientific communication on November 2022 atDMB congress : on the rescue decentralized digital plan, the associated CNIL authorization and DM\/IT interactions and tools<\/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<\/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: Timelines, logistics, sub-contractors management, reporting tools implementation, events management.<\/li>\n\n\n\n
              • Team work\/team building: Recruitment of patients in sports events by more than 30 ICTA members (from different departments) and external nurses.<\/li>\n\n\n\n
              • ICTA is completely able to manage uncommon innovative project, including setting up a digitalized decentralized solution (even though not activated because of a late CNIL authorization).<\/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>
                Patient recruitment: Stringent timelines & fieldwork during COVID-19 pandemics<\/strong><\/td>Anticipation of a rescue plan<\/strong>: virtual events to assure patient recruitment and data collection<\/td>While GCP, GDPR and ISO14155 compliant, implementation of digital solutions to ensure subject trial awareness, e-consent\/e-signature, race\/ non-serious dermatological condition verification and post event data collection) and inter-operability between all electronic tools.<\/td><\/tr>
                Subject-centered: self-treated condition, no physician involved<\/strong><\/td>Site staff composed of trained nurses to manage consent during on-event recruitment and via telemedicine for the rescue plan<\/td>Collaboration with subcontractor supplying services of study nurses.<\/td><\/tr>
                Compliance with MDR requirements<\/strong><\/td>Study documents prepared based on ISO14155 guidelines<\/td>Preparation of study document templates based on ISO14155:2020<\/td><\/tr>
                Sponsors\u2019 multiple requests during KOM, including the following:<\/strong>

                \u00b7  Numerous objectives\/endpoints to address multiple claims<\/strong>

                \u00b7  Several products to test and need for individual results per product<\/strong>

                \u00b7  Need to minimise cost\/number of hydrocolloid plaster types to provide and respect timelines (e.g. bonus\/malus)<\/strong>

                . Specific subpopulations (young, elderly, pregnant\/breastfeeding, controlled diabetes)\u2026<\/strong><\/td>                		Appropriate study design and methodology to address (almost) all Sponsor\u2019s requests by designing of two feasible studies.<\/td>Design and development of 2 distinct studies, implementation of randomisation algorithms, homemade questionnaires to assess relevant claims<\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div><\/section>\n\n\n\n
                  \n
                • <\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":7,"featured_media":10771,"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-7874","casclients","type-casclients","status-publish","has-post-thumbnail","hentry"],"acf":[],"uagb_featured_image_src":{"full":["https:\/\/www.icta.fr\/wp-content\/uploads\/non-serious-dermatological-condition-foot.jpg",200,100,false],"thumbnail":["https:\/\/www.icta.fr\/wp-content\/uploads\/non-serious-dermatological-condition-foot-128x88.jpg",128,88,true],"medium":["https:\/\/www.icta.fr\/wp-content\/uploads\/non-serious-dermatological-condition-foot.jpg",200,100,false],"medium_large":["https:\/\/www.icta.fr\/wp-content\/uploads\/non-serious-dermatological-condition-foot.jpg",200,100,false],"large":["https:\/\/www.icta.fr\/wp-content\/uploads\/non-serious-dermatological-condition-foot.jpg",200,100,false],"1536x1536":["https:\/\/www.icta.fr\/wp-content\/uploads\/non-serious-dermatological-condition-foot.jpg",200,100,false],"2048x2048":["https:\/\/www.icta.fr\/wp-content\/uploads\/non-serious-dermatological-condition-foot.jpg",200,100,false],"post-thumbnail":["https:\/\/www.icta.fr\/wp-content\/uploads\/non-serious-dermatological-condition-foot.jpg",200,100,false],"wpm_taille_1":["https:\/\/www.icta.fr\/wp-content\/uploads\/non-serious-dermatological-condition-foot.jpg",200,100,false],"wpm_taille_slider":["https:\/\/www.icta.fr\/wp-content\/uploads\/non-serious-dermatological-condition-foot.jpg",200,100,false],"gform-image-choice-sm":["https:\/\/www.icta.fr\/wp-content\/uploads\/non-serious-dermatological-condition-foot.jpg",200,100,false],"gform-image-choice-md":["https:\/\/www.icta.fr\/wp-content\/uploads\/non-serious-dermatological-condition-foot.jpg",200,100,false],"gform-image-choice-lg":["https:\/\/www.icta.fr\/wp-content\/uploads\/non-serious-dermatological-condition-foot.jpg",200,100,false]},"uagb_author_info":{"display_name":"Emmanuelle Guibelin","author_link":"https:\/\/www.icta.fr\/fr\/author\/iceg_6756\/"},"uagb_comment_info":0,"uagb_excerpt":null,"_links":{"self":[{"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/casclients\/7874","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\/7"}],"version-history":[{"count":15,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/casclients\/7874\/revisions"}],"predecessor-version":[{"id":8406,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/casclients\/7874\/revisions\/8406"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/media\/10771"}],"wp:attachment":[{"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/media?parent=7874"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/categories?post=7874"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}