Smart technology for diabetic foot monitoring
| ISRCTN | ISRCTN55615054 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55615054 |
| IRAS number | 338459 |
| Secondary identifying numbers | CPMS 62619 |
- Submission date
- 18/03/2025
- Registration date
- 27/03/2025
- Last edited
- 08/05/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Diabetes can damage nerves in the feet, leading to loss of sensation and increased risk of foot ulcers and amputations due to high pressure and rubbing forces (shear stress). Currently, there's no reliable way to measure shear stress in diabetic patients. This study aims to test a new method using custom socks to measure shear stress during walking in people with and without diabetic nerve damage, to see if it can differentiate between them and identify factors affecting shear stress.
Who can participate?
1. Adults with type 2 diabetes, with or without loss of sensation in their feet, who can walk independently.
2. Patients without diabetic peripheral neuropathy - Absence of diabetic peripheral neuropathy
3. Patients with diabetic peripheral neuropathy
4. Capable of walking independently (>50 metres)
5. Aged over 18 years
6. Presence of at least one pedal pulse
What does the study involve?
Participants will visit the lab for one day and walk on a treadmill while wearing custom socks, with and without shoes, for short periods. Foot sensation, medical history, and walking patterns will be assessed. Participants will also provide feedback on the comfort of the socks.
What are the possible benefits and risks of participating?
There are no direct benefits, but the study will help develop better ways to prevent foot ulcers in diabetic patients. There's a small risk of discomfort or rubbing during walking, which will be minimized and monitored.
Where is the study run from?
Gait and Biomechanics Laboratory, Manchester Metropolitan University (UK)
When is the study starting and how long is it expected to run for?
April 2024 to October 2025.
Who is funding the study?
1. Lancaster University (UK)
2. Engineering and Physical Sciences Research Council (EPSRC) (UK)
Who is the main contact?
Prof. Neil Reeves: n.d.reeves1@lancaster.ac.uk
Contact information
Public, Scientific, Principal Investigator
Medical School, Faculty of Health & Medicine
Lancaster University
Health Innovation One, University, Sir John Fisher Dr
Lancaster
LA1 4AT
United Kingdom
 ORCID ID |
0000-0001-9213-4580 |
|---|---|
| Phone | +44 1524522239 |
| n.d.reeves1@lancaster.ac.uk |
Study information
| Study design | Multi-centre cross-sectional observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | University/medical school/dental school |
| Study type | Screening, Safety, Efficacy |
| Participant information sheet | 47026 PIS_v2_25.07.24.pdf |
| Scientific title | Measurement of Foot Shear Stress for discriminating between patients with and without diabetic peripheral neuropathy |
| Study acronym | Socksess |
| Study hypothesis | The overall aims of this project are: 1. Investigate the efficacy of using a new approach for measuring foot dorsal and plantar shear stress in discriminating between two groups of diabetes patients with and without moderate to severe diabetic peripheral neuropathy. 2. Compare the shear stress measurement values at the foot to other gait parameters, including spatio-temporal variables, vertical pressure, and vertical and shear ground reaction forces. Primary Objective: This study aims to investigate the efficacy of using a new approach to measuring foot dorsal and plantar shear stress in discriminating between two groups of diabetes patients with and without moderate to severe neuropathy. Secondary Objectives: 1. Compare the shear stress measurement values to other gait parameters including spatio-temporal variables, vertical pressure, vertical and shear ground reaction forces. 2. To obtain patient feedback on the wearability and comfort of socks |
| Ethics approval(s) |
Approved 17/06/2024, East Midlands – Nottingham 2 NHS Research Ethics Committee (The Old Chapel Royal Standard Place, Nottingham, NG1 6FS, United Kingdom; +44 207 104 8009; nottingham2.rec@hra.nhs.uk), ref: 24/EM/0110 |
| Condition | Type 2 Diabetes Mellitus |
| Intervention | Participants are first screened against all inclusion/exclusion criteria and informed consent obtained. Afterwards, gait analysis will be assessed in different walking trials, and patient experience information will be collected via qualitative measurements. Identification and recruitment Participants will be identified and recruited from NHS hospital sites and via other routes, including volunteer databases including the NIHR Clinical Research Network ‘Research for the Future’, ‘ Measurement equipment Participants will walk on a treadmill instrumented with force platforms measuring vertical and two components of shear force. The treadmill can also measure vertical plantar pressure and can be inclined to different degrees. An optoelectronic system (Vicon system) including ten cameras will also be used to collect kinematic data during walking. Custom Socks Custom socks will be used to measure foot shear stress (also known as shear Strain). Thirty participants with and without diabetic neuropathy who meet the inclusion and exclusion criteria will be tested at the biomechanics lab. They will attend a single one-day session, at the start of which they will provide their informed written consent. Participants will perform four walking trials (after familiarisation with the treadmill), during which gait analysis data (kinetics and kinematics) will be collected. At the end of the walking trials, participants will be asked to complete a questionnaire to collect information about the comfort and performance of the custom socks. Biomechanics analysis In one laboratory session, the participants will undertake a series of walking trials on an instrumented treadmill while wearing the measurement socks with and without their footwear. During the walking tests, kinematic and kinetic data will be recorded using a combination of an optoelectronic motion capture system and force platforms embedded under the treadmill belt. These tools will allow the measurement of spatio-temporal gait parameters (i.e., step length, step width, stance time, swing time, double support time), ground reaction forces and torques in three directions to estimate shear stresses on the foot during the different walking tasks. Retroreflective markers (small balls that reflect light, often used for animations in movies and video games) will be placed on the participant’s ankle, feet, and legs up to the hip to collect 3D motion data. Medical history and neurological evaluation Participants will be asked to provide details about long-term complications and a history of previous ulcers. This information will be recorded by a member of the research team to have a detailed characterisation of the clinical condition of the participant. The presence and extent of diabetic peripheral neuropathy will be evaluated by researchers through a clinical score system, the modified Neuropathy Disability Score (mNDS), and quantitative sensory tests. The mNDS is a composite score representing the functional status of the sensory system (small and large fibres) at the lower extremities, comprising a series of simple clinical tests that examine pain sensitivity, temperature perception, vibratory sensation and tendon reflex responses. Quantitative measurements will include the assessment of the vibration perception threshold (VPT) using a neurothesiometer (Horwell, Nottingham, UK). VPT will be assessed at the halluces of both feet. This measure will allow the quantification of the functional status of the large sensory fibres. |
| Intervention type | Other |
| Primary outcome measure | Shear stresses measured using an instrumented treadmill while wearing the measurement socks in a single session |
| Secondary outcome measures | Measured in a single session: 1. Vertical forces measured using instrumented treadmill while wearing the measurement socks 2. Spatiotemporal parameters measured using instrumented treadmill while wearing the measurement socks |
| Overall study start date | 30/04/2024 |
| Overall study end date | 31/10/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Participant inclusion criteria | 1. Diagnosis of type 2 diabetes mellitus 2. Patients without diabetic peripheral neuropathy - Absence of diabetic peripheral neuropathy (vibration perception threshold (VPT) <15 Volts and modified neuropathy disability score (mNDS) <3) 3. Patients with diabetic peripheral neuropathy - presence of moderate to severe diabetic peripheral neuropathy according to a VPT ≥25 Volts and/or NDS >6. 4. Capable of walking independently (>50 metres) 5. Aged over 18 years 6. Presence of at least one pedal pulse |
| Participant exclusion criteria | 1. Active foot ulcer 2. Presence of Charcot deformity 3. Lower limb amputation (anything more than amputation of two lesser toes) 4. Presence of edema to the extent that it prevents normal wear of a sock 5. Persons unable to understand verbal and written information in English will be excluded from the study. |
| Recruitment start date | 01/07/2025 |
| Recruitment end date | 01/10/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Lancaster University
Lancaster
LA1 4YW
United Kingdom
Grosvenor Square
Manchester
M15 6BH
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Fountain Street
Ashton-under-lyne
OL6 9RW
United Kingdom
Sponsor information
University/education
Research Ethics Officer (Faculty of Health and Medicine)
Health Innovation One, University, Sir John Fisher Dr
Lancaster
LA1 4AT
England
United Kingdom
| Phone | +44 (0)1524 522285 |
|---|---|
| sponsorship@lancaster.ac.uk | |
| Website | https://www.lancaster.ac.uk |
"ROR" |
https://ror.org/04f2nsd36 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- UKRI Engineering and Physical Sciences Research Council, Engineering and Physical Sciences Research Council - UKRI, Engineering & Physical Sciences Research Council, EPSRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. Results will be disseminated publicly at scientific conferences, as research articles, via social media and press and participants will not be identifiable in any of these reports. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2 | 25/07/2024 | 18/03/2025 | No | Yes |
Additional files
Editorial Notes
08/05/2025: The recruitment start date was changed from 01/05/2025 to 01/07/2025.
03/04/2025: The recruitment start date was changed from 01/04/2025 to 01/05/2025.
18/03/2025: Trial's existence confirmed by NHS HRA.
