Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2026-01-22 @ 8:09 AM
Study NCT ID:
NCT01816906
Status:
COMPLETED
Last Update Posted:
2019-06-14
First Post:
2013-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Development and Testing of a New Generation of Diabetic Footwear
Sponsor:
Staffordshire University
Organization:
Study Overview
Official Title:
Development of a New Generation of DIABetic Footwear Using an Integrated Approach and SMART Materials
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DiaBSmart
Brief Summary:
This particular trial is looking to compare the effectiveness of two types of foot bed/ sole materials used within diabetic footwear.
Detailed Description:
DiaBSmart as a project aims to generate, transfer and exchange the clinical, academic and production knowledge between the partners to create a new generation of diabetic footwear through a newly developed patient assessment system. The transfer of knowledge between various sectors ensures that the need of patients is considered and transferred effectively to product development using a scientific approach. The objectives include:(1) the design and development of an integrated system of DIABetic foot assessment (2) to validate the newly developed system using experimental methods (3) to develop a suitable material to meet the mechanical and clinical requirements (4) to evaluate the mechanical and clinical effectiveness of material choice in reducing the potential risk of foot complications. The Numerical, Experimental and Mathematical Analyses system will integrate all aspects of diabetic footwear including; clinical and biomechanical assessment, material choice and aesthetic design. Proposed interdisciplinary, inter-sectorial approach is unique and brings together the expertise from research institutions, industry and clinics. This project while enhancing the knowledge base in diabetic assessment; will have a clear impact on new product development leading to both clinical and economic benefits. The products include a new generation of integrated SMART /multi material midsoles and/or orthoses for diabetic footwear. Properties of the materials will be optimised with a view to minimise/ redistribute the pressure and hence the stress on the soft tissue in the critical plantar areas of the foot. Whilst significantly affecting the course of the disease, the products will aim to reduce the risk of limb loss in patients with diabetes, the most frequent cause of non-traumatic lower-limb amputations.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| DiaBSmart -2011-IAPP | OTHER_GRANT | FP7-PEOPLE-2011-IAPP Grant Agreement Number 285985 | View |