Path Active Multicentre Randomised Controlled Trial (Previous Pilot: Path Active; Safety and Tolerability Study)

NCT06084052 | Recruiting

• 1 other identifier: 326601
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Path Active™ comprises a pair of monitoring insoles which measure parameters associated with foot ulceration in diabetes: temperature and pressure. The insoles are linked via an app to the wearer's mobile phone and also to a clinical dashboard so that both wearer and clinician are alerted to early signs of skin damage on the foot so that immediate preventive action can be taken. The study is a multisite randomised controlled trial which will evaluate the effectiveness of Path Active™ in 60 people with diabetes who are at 'high risk' of foot ulceration, compared with 60 people who receive their usual podiatry foot checks over a period of 12 weeks.

Conditions

Diabetic Foot

Keywords

Foot Ulcer Prevention

Outcome Measures

Primary Outcomes (4)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  The primary objective of this clinical investigation is to evaluate the effectiveness of Path Active™ in people with diabetes who are at 'high risk' of foot ulceration.

  6 months (Participants will wear the device for a minimum of 7 days)

• Changes Quality of Life Measurement

  EuroQol EQ-5D-5L assessment for quality of life assessment at the beginning and end of the study period. The EQ-5D-5L health profile includes the items mobility (MO), self-care (SC), usual activities (UA), pain/discomfort (PD) and anxiety/depression (AD). The EQ-5D-5L asks respondents to endorse one of five response levels for each item: "no problems," "slight problems," "moderate problems," "severe problems," and "extreme problems"/ "unable to", describing 3125 (55) health state profiles. The instrument also includes a visual analog scale (VAS) anchored by 0 (worst imaginable health) and 100 (best imaginable health) that will be analysed separately from the health profile.

  6 months (Participants will wear the device for a minimum of 12 weeks)

• Device questionnaire

  Participants in the 'Path Active' arm will complete study questionnaires relating to the product (ease of use, use of the mobile phone app, use of the insoles, action taken relating to app warnings).

  6 months (Participants will wear the device for a minimum of 12 weeks)

• Control Group questionnaire

  Participants in the 'Control Group' arm will complete study questionnaires relating to their usual care (how often do you see a healthcare professional for foot checks, how often do you examine your feet, how concerned are you about developing a foot ulcer etc)

  6 months

Secondary Outcomes (1)

• Reduction in CO2 comparing carbon dioxide emitted due to ulcer treatment vs carbon dioxide emitted due to device manufacture

  6 months (Participants will wear the device for a minimum of 12 weeks)

Study Arms (2)

Path Active

OTHER

Participants randomised to use the device

Device: Path Active

Control Group

OTHER

Participants randomised to care as usual

Other: Control Group

Interventions

Path Active DEVICE

Participant use of Path Active insoles, mobile phone app and clinician's dashboard (where pressure and temperature changes can be reviewed by a clinician). All participants will complete a patient questionnaire relating to use of the device and EuroQol - EQ5D at the beginning and end of the study.

Path Active

Control Group OTHER

Control Group will receive care as usual.

Control Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant able to give informed consent.
• Age \>18 at the time of consent.
• Diagnosis of Type 1 or Type 2 Diabetes.
• Both Feet Intact (no ulceration).
• Participant understands and is willing to participate and can comply with the follow-up regime.
• Participant diabetes foot Risk Stratification as 'High Risk' as in Frame (2021) Scotland/England https://www.diabetesframe.org/
• Ability to walk independently for \> 100 metres i.e without use of wheelchair, walking stick or personal assistance.
• Participant able and willing to wear suitable footwear.
• Must own a mobile phone and be willing to upload WWP app.

You may not qualify if:

• Either foot has less than 2 arterial vessel run-off on Doppler.
• Poor visual acuity ie registered blind, unless supported by carer.
• Current participation in another clinical investigation of a medical device or a drug; or participation in such a study within 30 days prior to study enrolment.
• Body Mass Index (BMI) \>40.
• Participant has bespoke contact insoles and footwear.
• Participant is unable to use 'medium' or 'large' insoles due to foot size eg. small or extra large feet.
• Participant has a pacemaker.
• Participant is pregnant.

Sponsors & Collaborators

• Royal Free Hospital NHS Foundation Trust: lead
• Walk With Path: collaborator

Study Sites (1)

Royal Free Hospital

London, NW3 2QE, United Kingdom

RECRUITING

Related Publications (4)

• Abbott CA, Chatwin KE, Foden P, Hasan AN, Sange C, Rajbhandari SM, Reddy PN, Vileikyte L, Bowling FL, Boulton AJM, Reeves ND. Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study. Lancet Digit Health. 2019 Oct;1(6):e308-e318. doi: 10.1016/S2589-7500(19)30128-1. Epub 2019 Sep 26.

  PMID: 33323253 RESULT

• Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. No abstract available.

  PMID: 28614678 RESULT

• Chatwin KE, Abbott CA, Boulton AJM, Bowling FL, Reeves ND. The role of foot pressure measurement in the prediction and prevention of diabetic foot ulceration-A comprehensive review. Diabetes Metab Res Rev. 2020 May;36(4):e3258. doi: 10.1002/dmrr.3258. Epub 2019 Dec 11.

  PMID: 31825163 RESULT

• Kerr M, Barron E, Chadwick P, Evans T, Kong WM, Rayman G, Sutton-Smith M, Todd G, Young B, Jeffcoate WJ. The cost of diabetic foot ulcers and amputations to the National Health Service in England. Diabet Med. 2019 Aug;36(8):995-1002. doi: 10.1111/dme.13973. Epub 2019 Jun 5.

  PMID: 31004370 RESULT

MeSH Terms

Conditions

Diabetic Foot

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Richard Leigh, BSc

  Royal Free London NHS Foundation Trust

  STUDY CHAIR

Central Study Contacts

Richard Leigh, BSc

CONTACT

+44208302749; richardleigh1@nhs.net

Lise Pape, MSc

CONTACT

lise@walkwithpath.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The participants will be randomised (using 'sealed envelope') to either 'care as usual' or 'use of device'.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: October 16, 2023
• Study Start: April 2, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)