Prevention & Treatment of a non-serious dermatological condition on the foot
CASE STUDY TYPE
Interventional Clinical Investigation Class 2a Medical Device
BACKGROUND
Prolonged friction of the skin against a sock or footwear leads to a non-serious dermatological condition, associated to discomfort and pain (and potential infections). Hydrocolloid plasters (CE marketed medical devices) act as a second skin thus protecting from further skin shearing/rubbing. They could be indicated in the prevention of non-serious dermatological conditions’ occurrence on feet. And, they may play a role in wound healing via occlusive conditions creation, moist wound healing, and cushioning and pain reduction. Some performances of hydrocolloid plasters have been previously demonstrated in clinical investigations but needed to be compliant with the new Medical Device Regulation (MDR) requirements. The clinical investigation was also planned to evaluate clinical performances/effectiveness of various hydrocolloid plasters in both the prevention and treatment of non-serious dermatological conditions on feet. Two studies were designed to achieve these goals: a preventive study and a curative study.
METHODS
- Preventive study: Interventional, confirmatory, post-marketing clinical follow-up (PMCF), subject-centered, pre/post, randomized, open-labelled, superiority study on paired groups.
- Curative study: Interventional, confirmatory, post-marketing clinical follow-up (PMCF), Subject-centered, longitudinal, randomized, open-labelled, superiority study on parallel groups, and 2 specific subcohorts (Paired subcohort & street-shoes subcohort).
OBJECTIVES
PRIMARY OBJECTIVES
- Preventive study: Prevention
- Curative study: Instant pain relief
SECONDARY OBJECTIVES
- Preventive study
- Plaster adhesion & rubbing off
- Duration of use
- Usability (only for hydrocolloid plasters)
- Global perception/satisfaction
- Safety (only for hydrocolloid plasters)
- Curative study
- Pain relief evolution
- Pressure relief
- Duration
- Time to Healing
SCIENTIFIC and DATA VALORISATION
- 2 Clinical Study Reports (ISO14155:2020 template)
- 4 Clinical Evaluation Reports (CER) updates performed by another provider (CER are key reports to update each product CE marking dossier)
- 2 Scientific publications ongoing Q1 2023
- 1 Scientific communication on November 2022 atDMB congress : on the rescue decentralized digital plan, the associated CNIL authorization and DM/IT interactions and tools
- Overall excellent client satisfaction, acknowledgment and trust
Key factors of success
- ICTA’s expertise in methodology/study design
- ICTA’s capability to propose innovative solutions for unusual projects
- ICTA’s responsiveness
LESSONS LEARNED to speed up the start-up phase of the next study
- Adaptability: Learn to work and communicate with a Sponsor who has a marketing-based culture rather than a scientific-based one.
- Optimal project coordination: Timelines, logistics, sub-contractors management, reporting tools implementation, events management.
- Team work/team building: Recruitment of patients in sports events by more than 30 ICTA members (from different departments) and external nurses.
- 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).
CHALLENGES
| KEY CHALLENGES | ICTA’s SOLUTIONS | ICTA’s ACHIEVEMENTS |
|---|---|---|
| Patient recruitment: Stringent timelines & fieldwork during COVID-19 pandemics | Anticipation of a rescue plan: virtual events to assure patient recruitment and data collection | 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. |
| Subject-centered: self-treated condition, no physician involved | Site staff composed of trained nurses to manage consent during on-event recruitment and via telemedicine for the rescue plan | Collaboration with subcontractor supplying services of study nurses. |
| Compliance with MDR requirements | Study documents prepared based on ISO14155 guidelines | Preparation of study document templates based on ISO14155:2020 |
| Sponsors’ multiple requests during KOM, including the following: · Numerous objectives/endpoints to address multiple claims · Several products to test and need for individual results per product · Need to minimise cost/number of hydrocolloid plaster types to provide and respect timelines (e.g. bonus/malus) . Specific subpopulations (young, elderly, pregnant/breastfeeding, controlled diabetes)… | Appropriate study design and methodology to address (almost) all Sponsor’s requests by designing of two feasible studies. | Design and development of 2 distinct studies, implementation of randomisation algorithms, homemade questionnaires to assess relevant claims |