Health Sciences Research Unit, Nursing (UICISA: E), Nursing School of Coimbra (ESEnfC), Coimbra, Portugal.
Indústrias e Comércio de Calçado S. A. (ICC), Sol-Pinheiro, Guimarães, Portugal.
Front Public Health. 2023 Jan 30;11:1061383. doi: 10.3389/fpubh.2023.1061383. eCollection 2023.
The incidence of diabetic foot ulceration (DFU) is increasing worldwide. Therapeutic footwear is usually recommended in clinical practice for preventing foot ulcers in persons with diabetes. The project Science DiabetICC Footwear aims to develop innovative footwear to prevent DFU, specifically a shoe and sensor-based insole, which will allow for monitoring pressure, temperature, and humidity parameters.
This study presents a three-step protocol for the development and evaluation of this therapeutic footwear, specifically: (i) a first observational study will specify the user requirements and contexts of use; (ii) after the design solutions were developed for shoe and insole, the semi-functional prototypes will be evaluated against the initial requirements; (iii) and a pre-clinical study protocol will enable the evaluation of the final functional prototype. The eligible diabetic participants will be involved in each stage of product development. The data will be collected using interviews, clinical evaluation of the foot, 3D foot parameters and plantar pressure evaluation. This three-step protocol was defined according to the national and international legal requirements, ISO norms for medical devices development, and was also reviewed and approved by the Ethics Committee of the Health Sciences Research Unit: Nursing (UICISA: E) of the Nursing School of Coimbra (ESEnfC).
The involvement of end-users (diabetic patients) will enable the definition of user requirements and contexts of use to develop design solutions for the footwear. Those design solutions will be prototyped and evaluated by end-users to achieve the final design for therapeutic footwear. The final functional prototype will be evaluated in pre-clinical studies to ensure that the footwear meets all the requirements to move forward to clinical studies.
The three-step study outlined in this protocol will provide the necessary insights during the product development, ensuring this new therapeutic footwear's main functional and ergonomic features for DFU prevention.
糖尿病足溃疡（DFU）的发病率在全球范围内呈上升趋势。临床上通常建议糖尿病人使用治疗性鞋具来预防足部溃疡。“科学糖尿病足鞋具”项目旨在开发预防 DFU 的创新鞋具，具体为一种鞋和基于传感器的鞋垫，可监测压力、温度和湿度参数。
本研究提出了治疗性鞋具开发和评估的三步方案，具体为：（i）首先进行观察性研究，明确用户需求和使用场景；（ii）设计出鞋具和鞋垫的解决方案后，将对半功能原型进行评估，以检验其是否符合初始要求；（iii）最后，将制定临床前研究方案，以评估最终的功能原型。合格的糖尿病患者将参与产品开发的各个阶段。将通过访谈、足部临床评估、3D 足部参数和足底压力评估来收集数据。本三步方案是根据国家和国际法律要求、医疗器械开发的 ISO 规范制定的，并经过科英布拉健康科学研究单位护理学部伦理委员会（UICISA：E）和科英布拉护理学院护理研究单位（ESEnfC）的审查和批准。
让终端用户（糖尿病患者）参与其中，将有助于确定用户需求和使用场景，从而为鞋具开发设计解决方案。这些设计解决方案将由终端用户进行原型评估，以实现治疗性鞋具的最终设计。最终的功能原型将在临床前研究中进行评估，以确保鞋具符合所有要求，从而推进临床研究。
本方案中概述的三步研究将在产品开发过程中提供必要的见解，确保这种新型治疗性鞋具的主要功能和人体工程学特征符合 DFU 预防的要求。
