TY - JOUR
T1 - A three step protocol for the development of an innovative footwear (shoe and sensor based insole) to prevent diabetic foot ulceration
AU - Sousa, Liliana B.
AU - Almeida, Inês
AU - Bernardes, Rafael A.
AU - Leite, Teófilo R.
AU - Negrão, Rui
AU - Apóstolo, João
AU - Salgueiro-Oliveira, Anabela
AU - Parreira, Pedro
N1 - Funding Information:
This research was funded by the Research and Technological Development Incentive System (SI I&DT Co-Promotion), with the grant reference POCI-01-0247-FEDER-039784.
Funding Information:
The authors would like to thank the support of the Health Sciences Research Unit: Nursing (UICISA: E) from the Nursing School of Coimbra (ESEnfC). The authors IA (UIDB/00742/2020) and RAB (UI/BD/151102/2021) thank the Portuguese National Funding Agency for Science, Research and Technology (FCT) for the financial support granted.
Publisher Copyright:
Copyright © 2023 Sousa, Almeida, Bernardes, Leite, Negrão, Apóstolo, Salgueiro-Oliveira and Parreira.
PY - 2023/1/30
Y1 - 2023/1/30
N2 - Background: 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. Method: 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). Results: 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. Discussion: 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.
AB - Background: 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. Method: 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). Results: 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. Discussion: 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.
KW - Diabetic foot ulcers (DFUs)
KW - Footwear
KW - Prevention
KW - Sensor-based insoles
KW - Shoes
UR - http://www.scopus.com/inward/record.url?scp=85147993895&partnerID=8YFLogxK
U2 - 10.3389/fpubh.2023.1061383
DO - 10.3389/fpubh.2023.1061383
M3 - Article
C2 - 36794077
AN - SCOPUS:85147993895
SN - 2296-2565
VL - 11
JO - Frontiers in Public Health
JF - Frontiers in Public Health
M1 - 1061383
ER -
