Happier Feet- A Smart Insole for Diabetic Foot Ulceration Prevention

NCT05865353 | Completed

• 2 other identifiers: 2021-22-30307041
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to design, develop, and evaluate a smart insole to predict the formation of diabetic foot ulcers (DFUs) in diabetic participants at risk of developing them. The study will be conducted in two phases, using mixed-method research and engaging both diabetic participants and NHS clinicians. In Phase 1, the user-centred design of the smart insole will be developed through focus groups and online questionnaires, and a preliminary safety evaluation of the insole will be conducted with healthy team members. In Phase 2, the insole will be tested, validated, and data will be collected through baseline visits, lab studies, and insole data collection with shape-changed (pressure off-loading) insoles. The study will be conducted by researchers from the University of Manchester and the University of Exeter. It will include 10 people with diabetes and 10 healthy controls in Phase 2.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Shear data

  Shear data The primary outcome measure includes testing the reliability of the smart insole in collecting 1. Shear stress data (KPa) while walking at a self-selected speed on the treadmill for 15 minutes 2. walking on the floor for 2 minutes. 3. standing on the floor for 5 minutes.

  Participant visit is for 90 minutes and data collection is for the (15 minutes walk, 2 minutes and standing still for 5 minutes)

Study Arms (2)

Diabetes

Ten Diabetic participants at risk of DFU/ in this cross-sectional study, participants will be asked to use the smart insole and complete sitting, standing and walking task

Healthy control

Ten healthy participants without movement disorder or Diabetes. The same tasks (sitting, standing and walking) while wearing the smart insole will be repeated for the control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises 20 individuals from both genders, divided into two groups: a Diabetic Group consisting of 10 patients with a confirmed diagnosis of diabetes who are at risk of developing or have a history of diabetic foot ulcer (DFU), and a Healthy Control Group consisting of 10 individuals with no diagnosis of diabetes or movement disorder. The selection criteria for the Diabetic Group include a confirmed diagnosis of diabetes and a history or risk of developing DFU, while the Healthy Control Group includes individuals with no known medical conditions that could affect their movement or balance.

You may qualify if:

• Confirmed diagnosis of diabetes
• )At the risk of developing a DFU 2) Able to understand and communicate to safely participate \[Brief Assessment of Capacity 3) to have a score at least 6/8 (UBACC)\]Capacity to participate 4) capability to walk for 10 mins without rest 5) Be able to walk for 30 minutes with no pain, no walking aid, and take breaks if required.
• \) Must have sensation on their feet 7) Able to walk without a walking aid or orthotic.

You may not qualify if:

• Below 18 years old
• Contradictions to walking and physical activity
• Broken skin on the foot
• Suffering from a skin condition such as severe eczema or skin allergies
• Pain affecting the ability to walk.
• Healthy participants
• Above 18 years old
• Able to walk for 30 minutes with no pain, no walking aid, and taking breaks if required.
• No contraindications to walking and physical activity
• No broken skin on the foot
• Do not suffer from a skin condition such as severe eczema or skin allergies.
• below 18 years old
• Any movement disorder
• Pain during the walk
• Broken skin on the foot.

Sponsors & Collaborators

• University of Exeter: lead
• University of Manchester: collaborator
• Loughborough University: collaborator
• University of Southampton: collaborator
• University of Strathclyde: collaborator

Study Sites (1)

University of Exeter

Exeter, EX1 2LU, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Helen Dawes, PhD

  Professor of Clinical Rehabilitations

  PRINCIPAL INVESTIGATOR

• Andrew Weightman, PhD

  Professor of Medical Mechatronics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: May 18, 2023
• Study Start: February 1, 2023
• Primary Completion: August 30, 2023
• Study Completion: September 30, 2023
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)