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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot
• Intervention / Treatment: Device: Path Active; Other: Control Group

Detailed Description

Foot complications in people with diabetes are the most common cause of non-traumatic leg amputation in the UK with over 176 leg, toe or foot amputations every week in England. One in seven people with diabetes will develop a foot ulcer at some stage in their lives. Not only does this impair their daily activities and reduce their quality of life, it also increases their risk of amputation by up to 24-fold. Five year mortality for minor and major amputations in diabetes have been reported as 46.2% and 56.6%, respectively. Circulatory problems, nerve impairment and infection contribute to foot complications in diabetes. Prior to a foot ulceration, changes in temperature and/or pressure occur. These early warning signs can be measured by Path Active™ and alert the wearer via a mobile phone app and the clinician via a clinical dashboard so that preventive action can be taken. Currently people with diabetes who have been assessed as 'high risk' for foot ulceration are allocated appointments with podiatrists in 'foot protection teams' who review on a weekly to monthly basis. Path Active™ has the potential to reduce appointments by alerting podiatry teams to potential problems as they occur rather than regular routine reviews. Path Active™ may be able to reduce hospital and clinic visits and thereby reduce healthcare carbon footprint.

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. 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. Recruitment to the study will be in 4 clinical sites across England and Scotland.

The protocol for this study was amended from the pilot study and accepted as a 'major amendment' by the regional Ethics Committee of Essex. Therefore the IRAS number (Unique Protocol ID: 326601) has remained the same.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Richard Leigh, BSc; Phone Number: +44208302749; Email: richardleigh1@nhs.net
• Study Contact Backup: Name: Lise Pape, MSc; Email: lise@walkwithpath.com

Study Locations

• United Kingdom
  • London, United Kingdom, NW3 2QE
    • Recruiting
    • Royal Free Hospital
    • Contact: Richard Leigh, BSc; Phone Number: +44208302749; Email: richardleigh1@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Path Active; Participants randomised to use the device	Device: Path Active; 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.
Other: Control Group; Participants randomised to care as usual	Other: Control Group; Control Group will receive care as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in CO2 comparing carbon dioxide emitted due to ulcer treatment vs carbon dioxide emitted due to device manufacture	To model the carbon dioxide reduction that occurs if ulceration and the need for ulcer treatment is prevented, in differing UK geographies. The carbon footprint for the manufacture and life span of the device will been calculated and the carbon footprint for ulcer treatment will be calculated. The difference between CO2 due to manufacture of the device will be compared with the CO2 required for ulcer treatment to show how much reduction in carbon can be made by preventing foot ulceration when using Path Active.	6 months (Participants will wear the device for a minimum of 12 weeks)

Collaborators and Investigators

• Sponsor: Royal Free Hospital NHS Foundation Trust
• Collaborators: Walk With Path
• Investigators: Study Chair: Richard Leigh, BSc, Royal Free London NHS Foundation Trust

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Foot Ulcer Prevention
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot
• Other Study ID Numbers: 326601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No