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Path Active; Safety and Tolerability Study (PASTS)

Primary Purpose

Diabetic Foot

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Path Active
Sponsored by
Royal Free Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Foot

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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'. 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. Most 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.

Sites / Locations

  • Royal Free HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Path Active

Arm Description

All participants will use the device. There is no comparator.

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The primary objective of this clinical investigation is to evaluate any adverse events whilst using Path Active™ in people with diabetes who are at 'high risk' of foot ulceration.
Quality of Life
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.
Device questionnaire
Participants 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)

Secondary Outcome Measures

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. 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.

Full Information

First Posted
August 22, 2023
Last Updated
October 11, 2023
Sponsor
Royal Free Hospital NHS Foundation Trust
Collaborators
Walk With Path
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1. Study Identification

Unique Protocol Identification Number
NCT06084052
Brief Title
Path Active; Safety and Tolerability Study
Acronym
PASTS
Official Title
Path Active; Safety and Tolerability Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
November 17, 2023 (Anticipated)
Study Completion Date
November 24, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal Free Hospital NHS Foundation Trust
Collaborators
Walk With Path

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 will assess safety and tolerability of Path Active™ in 10 users, who have been assessed as having a 'high risk' of foot ulceration, over a period of 7 days.
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 safety and tolerability of Path Active™ in people with diabetes who are at 'high risk' of foot ulceration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Path Active
Arm Type
Other
Arm Description
All participants will use the device. There is no comparator.
Intervention Type
Device
Intervention Name(s)
Path Active
Intervention Description
Participant use of Path Active insoles, mobile phone app and clinician's dashboard (where pressure and temperature changes can be reviewed by a clinician). Participants will complete a patient questionnaire relating to use of the device and EuroQol - EQ5D at the beginning and end of the study.
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
The primary objective of this clinical investigation is to evaluate any adverse events whilst using Path Active™ in people with diabetes who are at 'high risk' of foot ulceration.
Time Frame
3 months (Participants will wear the device for a minimum of 7 days)
Title
Quality of Life
Description
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.
Time Frame
3 months (Participants will wear the device for a minimum of 7 days)
Title
Device questionnaire
Description
Participants 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)
Time Frame
3 months (Participants will wear the device for a minimum of 7 days)
Secondary Outcome Measure Information:
Title
Reduction in CO2 comparing carbon dioxide emitted due to ulcer treatment vs carbon dioxide emitted due to device manufacture
Description
To model the carbon dioxide reduction that occurs if ulceration and the need for ulcer treatment is prevented. 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.
Time Frame
3 months (Participants will wear the device for a minimum of 7 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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'. 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. Most 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Leigh, BSc
Phone
+44208302749
Email
richardleigh1@nhs.net
Facility Information:
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Leigh, BSc
Phone
+44208302749
Email
richardleigh1@nhs.net

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33323253
Citation
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.
Results Reference
result
PubMed Identifier
28614678
Citation
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.
Results Reference
result
PubMed Identifier
31825163
Citation
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.
Results Reference
result
PubMed Identifier
31004370
Citation
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.
Results Reference
result

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Path Active; Safety and Tolerability Study

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