Path Active Multicentre Randomised Controlled Trial (Previous Pilot: Path Active; Safety and Tolerability Study)
Phase: NA
Conditions: Diabetic Foot
Sponsor: Royal Free Hospital NHS Foundation Trust

 
Podiatry Department 
Pond Street 
London  
NW3 2QG 
Tel: 020 7794 0500 
Page 1 of 25 
PAM RCT Protocol V1.4 12.06.2024 Protocol No: WWPP2.001 
FULL/LONG TITLE OF THE STUDY 
Path Active Multicentre Randomised Controlled Trial   
 
SHORT STUDY TITLE / ACRONYM 
PAM RCT 
 
PROTOCOL VERSION NUMBER AND DATE 
V1.4 – 11.06.2024 
 
RESEARCH REFERENCE NUMBERS 
IRAS Number: 
326601 
SPONSOR Number: 
WWPP2.001 
REC Number: 
23/EE/0080  
 
CHIEF INVESTIGATORS (CI): 
Richard Leigh  
Podiatry Department  
 
 
 
Royal Free London NHS Foundation Trust 
 
 
 
Royal Free Hospital 
 
 
 
 
 
Pond Street, Hampstead 
 
 
 
 
London NW3 2QG 
 
 
 
 
 
 
Phone: 020 7794 0500 ext 38076 
 
 
 
 
 
Email: Richardleigh1@nhs.net 
 
  
 
SPONSOR:       Walk With Path                                   
Representative of the Sponsor: 
Miss Lise Pape, 
Walk With Path Head Office, 
54 Sun Street, Waltham Abbey, 
Essex, UK EN9 1EJ 
Phone: +44 7976842669 
Email: lise@walkwithpath.com 
 
 
Funding Source: SBRI Healthcare Selection Panel. Ref SBRIH22P2006 
 
 

 
 
 
 
 
 
 
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WWPP2 PAM RCT Protocol V1.4 12.06.2024 Protocol No: WWPP2.001 
 
 
Information in this protocol is confidential and should not be disclosed, other than to those directly 
involved in the execution or the ethical review of the study, without written authorisation from Royal 
Free London’s R&D Office or its affiliates. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SIGNATURE PAGE  

 
 
 
 
 
 
 
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WWPP2 PAM RCT Protocol V1.4 12.06.2024 Protocol No: WWPP2.001 
 
 
Chief Investigator Declaration 
 
The Chief Investigator (CI) and the Sponsor representative have discussed this protocol version. The 
investigators agree to perform the investigations and to abide by this protocol except where departures 
from it are mutually agreed in writing. 
 
The Investigator agrees to conduct the trial in compliance with the approved protocol, GCP, the Data 
Protection Act (2018), the Trust’s Information Governance Policy (or other local equivalent), the UK 
Policy Framework for Health and Social Care (Last updated on 6 September 2023), the Sponsor’s SOPs, 
and other regulatory requirements as appropriate. 
 
This protocol has been written in accordance to the procedure identified as: SOP029 ‘Applying for Royal 
Free Sponsorship’ and is intended for use at UK sites only. 
 
For and on behalf of the Study Sponsor: 
Signature:  
.................................. .................................................................... 
 
Date: ..../..../.... 
Name (please print): 
…………………................................................................................. 
 
 
Position: ..................................................................................................... 
 
 
 
Chief Investigator: Richard Leigh 
Chief Investigator Site: Royal Free London NHS Foundation Trust 
 
Signature: ............................................................. 
 
Date: 
….../….../…... 
Name: (please print): 
Richard Leigh..................................................................................... 
 
 
 
 
Acknowledgements and Protocol contributories 
 

 
 
 
 
 
 
 
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WWPP2 PAM RCT Protocol V1.4 12.06.2024 Protocol No: WWPP2.001 
 
Chief Investigator 
Richard Leigh (Consultant Podiatrist RFH, visiting professor 
PSMU) 
Study Co-ordinator/Manager 
N/A 
Sponsor 
Walk With Path 
Funder(s) 
SBRI 
Key Protocol Contributors 
Miss Lise Pape, 
Walk With Path Head Office, 
54 Sun Street, Waltham Abbey, 
Essex, UK EN9 1EJ 
 
lise@walkwithpath.com 
 
+44 7976842669 
 
Committees 
RFL Trials Feasibility Committee 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
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WWPP2 PAM RCT Protocol V1.4 12.06.2024 Protocol No: WWPP2.001 
 
Contents    
1.0 
LIST OF ABBREVIATIONS/GLOSSARY OF TERMS .................................................................. 8 
2.0 
ROLES AND RESPONSIBILITIES ............................................................................................. 8 
3.0 
STUDY SUMMARY ................................................................................................................ 9 
4.0 
STUDY FLOW CHART .......................................................................................................... 11 
5.0 
INTRODUCTION .................................................................................................................. 12 
5.1 
BACKGROUND ........................................................................................................................ 12 
5.2 
RATIONALE ............................................................................................................................ 12 
6.0 
RESEARCH QUESTIONS ...................................................................................................... 13 
6.1 
PRIMARY AIM ........................................................................................................................ 13 
7.0 
TRIAL DESIGN ..................................................................................................................... 13 
7.1 
METHOD ................................................................................................................................ 13 
8.0 PARTICIPANT SELECTION CRITERIA .......................................................................................... 14 
8.1 
INCLUSION CRITERIA ............................................................................................................... 14 
8.2 
EXCLUSION CRITERIA .............................................................................................................. 15 
8.3 
DISCONTINUATION/WITHDRAWAL OF PARTICIPANTS ............................................................... 15 
9.0 
PARTICIPANT RECRUITMENT PROCESS .............................................................................. 15 
10.0 
STUDY PROCEDURES .......................................................................................................... 15 
10.1 
INFORMED CONSENT .............................................................................................................. 16 
11.0 
ADVERSE AND SERIOUS ADVERSE EVENTS ........................................................................ 18 
11.1 
GENERAL DEFINITIONS ...................................................................................................... 18 

 
 
 
 
 
 
 
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WWPP2 PAM RCT Protocol V1.4 12.06.2024 Protocol No: WWPP2.001 
 
An Adverse Event (AE) is any untoward medical occurrence in a patient or a clinical trial 
subject which does not necessarily have a causal relationship with the 
device/procedure............................................................................................................... 18 
12.0 OPERATIONAL DEFINITIONS OF (S)AES .................................................................................. 18 
12.0.1 Expected (S)AEs - Not Reportable....................................................................................... 18 
13.0 
DATA MANAGEMENT AND QUALITY ASSURANCE............................................................. 19 
13.1 
CONFIDENTIALITY ................................................................................................................... 19 
13.2 DATA COLLECTION ..................................................................................................................... 20 
13.3 DATA HANDLING AND ANALYSIS ................................................................................................. 20 
13.4 TRANSFERRING/TRANSPORTING DATA ........................................................................................ 20 
14.0 
ARCHIVING ......................................................................................................................... 20 
15.0 ENDPOINT DESIGN ................................................................................................................. 20 
15. 1 ENDPOINTS .............................................................................................................................. 21 
15.1.1 
PRIMARY ENDPOINTS ....................................................................................................... 21 
15.1.2  
SECONDARY ENDPOINTS ................................................................................................... 21 
15.2 
ANALYSIS PLANS .................................................................................................................... 21 
15.2.1  
PRIMARY ENDPOINT ANALYSIS .......................................................................................... 21 
16.0 
DIRECT ACCESS TO SOURCE DATA ..................................................................................... 21 
17.0 
ETHICS AND GOVERNANCE REQUIREMENTS ..................................................................... 21 
17.1 DEFINITION OF THE END OF TRIAL ............................................................................................... 22 
17.2 ANNUAL PROGRESS REPORTS (APRs) ........................................................................................... 22 
17.3 PROTOCOL COMPLIANCE ............................................................................................................ 22 
18.0 
FINANCE ............................................................................................................................. 22 
19.0 
PEER REVIEW ..................................................................................................................... 23 

 
 
 
 
 
 
 
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WWPP2 PAM RCT Protocol V1.4 12.06.2024 Protocol No: WWPP2.001 
 
20.0 
PUBLIC AND PARTICIPANT INVOLVMENT .......................................................................... 23 
21.0 
INDEMNITY......................................................................................................................... 23 
22.0 
IP AND DEVELOPMENT POLICY .......................................................................................... 23 
23.0 
PUBLICATION AND DISSEMINATION POLICY ..................................................................... 23 
24.0 STATEMENT OF COMPLIANCE ............................................................................................... 24 
25.0 REFERENCES ........................................................................................................................... 24 
26.0 
APPENDICIES ...................................................................................................................... 25 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
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WWPP2 PAM RCT Protocol V1.4 12.06.2024 Protocol No: WWPP2.001 
 
1.0 LIST OF ABBREVIATIONS/GLOSSARY OF TERMS 
CI 
Chief Investigator 
CRF  
Case Report Form 
GCP 
Good Clinical Practice 
ISF 
Investigator Site File 
MDFT 
Multidisciplinary Footcare Team 
REC 
Research Ethics Committee 
RFL 
Royal Free London NHS Foundation Trust 
SOP 
Standard Operating Procedure  
 
2.0 ROLES AND RESPONSIBILITIES  
CHIEF INVESTIGATOR (CI): 
Prof Richard Leigh,  
Podiatry Dept, 
Royal Free Hospital, 
Pond Street,  
London NW2 3QE 
 
Phone: 020 7830 2749 
 
 
 
 
 
Email: richardleigh1@nhs.net 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
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Page 9 of 25 
WWPP2 PAM RCT Protocol V1.4 12.06.2024 Protocol No: WWPP2.001 
 
3.0 STUDY SUMMARY 
Official title:  
Path Active; A multicentre randomised controlled trial   
Brief title /Acronym: 
PAM RCT 
Sponsor reference  
number: 
WWPP2.002 
Public database trial 
ID: 
TBC 
Research Question 
To evaluate the effectiveness of Path Active™ in people with 
diabetes who are at 'high risk' of foot ulceration. 
 
Study design 
Multicentre effectiveness randomised controlled trial   
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.  
- 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. 
- Active osteomyelitis (bone infection) suspected or diagnosed.  
- Active Charcots neuroarthropathy.      
- 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.  

 
 
 
 
 
 
 
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WWPP2 PAM RCT Protocol V1.4 12.06.2024 Protocol No: WWPP2.001 
 
- Participant is pregnant.                                                                                
Anticipated start date 
2nd April 2024 
Anticipated end date 
31st March 2025 
Target number of 
participants 
120 
Primary aim(s) 
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. 
Secondary aim(s) 
To establish the ‘carbon footprint’ of Path Active in different 
geographies.   
Sources of funding 
SBRI Healthcare Selection Panel. Ref SBRIH22P2006 
Sponsor 
Walk With Path 
Contact name 
Sponsor representative: 
Miss Lise Pape, 
Walk With Path Head Office, 
54 Sun Street, Waltham Abbey, 
Essex, UK EN9 1EJ 
Phone: +44 7976842669 
Email: lise@walkwithpath.com 
 
Chief Investigator: 
Prof Richard Leigh, Podiatry Dept, Royal Free London NHS 
Foundation Trust, Royal Free Hospital, Pond Street, Hampstead, 
London, NW3 2QG                                                 
Phone: 020 7830 2749 
Email: richardleigh1@nhs.net 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
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Page 11 of 25 
WWPP2 PAM RCT Protocol V1.4 12.06.2024 Protocol No: WWPP2.001 
 
 
 
 
 
 
 
 
 
4.0 STUDY FLOW CHART 
 
 
 
 
 
 
 
Pre Assessment
 
 nformed  onsent
 
 edical History
 
Arterial Doppler scan
 
Test for  europathy
 
 ligibility con rma on
 
Par cipant Training in device
and mobile app use.
 
 oL Assessment
 
Pa ent  ues onnaire
Path Ac ve  roup
Randomisa on
 ontrol  roup
n  20
 
Par cipant contacted by
research team
 
Adverse  vents revie 
 
Rapid clinical care if
necessary
Day   
 
 oL Assessment
 
Pa ent  ues onnaire
 
Device retained by clinical
research team.
Par cipa on discussed
 ith poten al par cipant
and clinical research team
 et een day 0 and day   
if Path Ac ve detects
change in temperature or
pressure or  ontrol  roup
par cipant has concern or
an A .
                      
 
 nformed  onsent
 
 edical History
 
Arterial Doppler scan
 
Test for  europathy
 
 ligibility con rma on
 
 oL Assessment
 
Pa ent  ues onnaire
 
Par cipant contacts research
team
 
Adverse  vents revie 
 
Rapid clinical care if
necessary
 
 oL Assessment
 
Pa ent  ues onnaire
                   

 
 
 
 
 
 
 
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WWPP2 PAM RCT Protocol V1.4 12.06.2024 Protocol No: WWPP2.001 
 
 
 
 
 
5.0 INTRODUCTION 
5.1 BACKGROUND 
More than 4.9M people have been diagnosed with diabetes (DM) in the UK, and up to 25% (1.2M ) 
will develop a Diabetic Foot Ulcer (DFU) in their lifetimes. 15-20% of DFUs lead to amputations which 
are followed by significantly increased mortality. The cost to taxpayers is enormous (Kerr 2019), 
consuming 1% of NHS budget annually.  
 
The current method of providing periodic foot checks is inadequate, with the chance of recurrence of 
an ulcer being 40% in the first year, rising to almost 100% over 10 years (Armstrong 2017).   
Individuals at high risk of DFU go to clinic to have their feet checked at least once a month. This can be 
highly disruptive to their everyday lives. Furthermore, there is considerable environmental cost of   
patient travel and if a DFU occurs single-use consumables for treatment such as dressings, bandages, 
scalpels, blood tests, cultures for microbiology , etc.  
 
 
5.2 RATIONALE 
Foot ulceration and infection is a major factor leading to morbidity (amputation) and mortality. There 
are multiple comorbidities which can lead to foot ulceration and infection such as peripheral arterial 
disease and diabetes. The estimated cost of foot care in England for people with diabetes and foot 
ulceration alone is £1billion (Kerr 2019) with around 9000 amputations a year (one an hour). Many 
amputations occur due to ulceration leading to infection.       
 
Path Active is an advanced at-home foot health monitoring system that combines unique patented, 
sensor-rich insoles and patient-adapted machine learning to prevent DFUs. Path Active does this by 
accurately mapping and measuring a person’s foot pressure and temperature distribution to calculate 
increasing risk of foot ulceration and allow users to take appropriate actions to reduce their DFU risk. 
For patients, a highly-visual dedicated UI (User Interface - app & web portal), with embedded 
behavioural science-led ‘nudge methodology’, supports and encourages them to offload (rest) their 
feet to prevent DFU development and liaise remotely with their clinician. These systems have been 
shown to reduce DFU recurrence with the single modality of pressure measurement (Chatwin 2021; 
Abbott 2019). Additionally, Path Feel measures temperature change as a precursor to foot disease as 
well as pressure and reduces the need for frequency of clinic visits by providing at-home monitoring. 
Alerts are also captured on a clinical dashboard by the patient’s clinical team which will alert them to 
potential foot problems and so they can contact the patient and provide rapid clinical care when 
required.   
 

 
 
 
 
 
 
 
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WWPP2 PAM RCT Protocol V1.4 12.06.2024 Protocol No: WWPP2.001 
 
From a healthcare professional’s perspective, the platform provides a major opportunity to save time 
and personalise care, focusing on only those patients who need help. 
6.0 
RESEARCH QUESTIONS  
• Is Path Active as effective as regular routine podiatry review in foot ulcer prevention?  
• Does using Path Active improve participant QoL? 
• Are there any suggestions from participants to improve the device/app? 
• Will preventing foot ulceration reduce NHSE carbon footprint? 
 
6.1 PRIMARY AIM 
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 compared to regular routine podiatry 
clinical review. 
 
6.2 SECONDARY AIMS 
      To model the carbon dioxide reduction that mat occur if ulceration and the need for ulcer              
       treatment is prevented, in differing UK geographies.  
7.0 TRIAL DESIGN  
7.1 METHOD  
Study setting 
Participants  ho have been assessed as having a ‘high risk’ of foot ulceration will be recruited from 
Community Foot Protection Teams in 4 sites across the UK. Participants will be recruited to the study 
to a maximum total of 120 (30 at each site) who have completed the study. The number of recruits 
required is based on a power calculation for the study at the 95% confidence interval.   
The study is anticipated to run for 12 months.   
 
Procedure 
Potential participants will be approached to participate during routine review by the Community Foot 
Protection Teams and consented by them for the study. All participants will be screened at pre-
assessment by the Community Foot Protection Teams.    
 
Following completion of informed consent the participant will have;  
• Medical History 
• Arterial Doppler scan 

 
 
 
 
 
 
 
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WWPP2 PAM RCT Protocol V1.4 12.06.2024 Protocol No: WWPP2.001 
 
• Test for Neuropathy  
• Eligibility confirmation 
• EuroQoL Assessment (EQ-5D-5L) 
• Patient Questionnaire 
• Randomised to ‘Path Active  roup’ or ‘ ontrol  roup’ using computer randomisation.  
 
If the participant is randomised to use the device in the ‘Path Active  roup’; 
• Participant Training in device and mobile app use (Appendix 1).  
 
If there is an alert from Path Active app the participant will be asked to reduce walking and rest their 
feet. If the alert continues and activates the clinical dashboard, patients will be contacted to attend 
clinic for review.  
 
If the participant is not randomised to use the device in the ‘ ontrol  roup’, they will continue with 
their regular podiatry clinical reviews with the Community Foot Protection Team who will provide 
their standard of care.  
 
Day 84 (week 12). At the end of study;  
• EuroQoL Assessment (EQ-5D-5L) 
• Patient Questionnaire 
If the participant is randomised to use the device; 
• Device retained by clinical research team. 
8.0 PARTICIPANT SELECTION CRITERIA  
Interested participants thought to be appropriate for the study will be approached by the local 
Community Foot Protection Team. Following informed consent, participants will be assigned a subject 
ID and their status checked that they satisfy inclusion and exclusion criteria prior to admitting them to 
the trial. Participants will be excluded if they do not satisfy inclusion and/or exclusion criteria.  
 
8.1 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/  

 
 
 
 
 
 
 
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WWPP2 PAM RCT Protocol V1.4 12.06.2024 Protocol No: WWPP2.001 
 
• 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.  
 
 
8.2 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.   
 
8.3 DISCONTINUATION/WITHDRAWAL OF PARTICIPANTS  
The participant will remain free to withdraw at any time from the study without giving reasons and 
without prejudicing his/her further treatment and will be provided with a contact point where he/she 
may obtain further information about the study. If participants withdraw the data already collected will 
be anonymously utilised, but no further data will be collected. 
9.0 PARTICIPANT RECRUITMENT PROCESS  
The study will only commence once evidence of the following approval/essential documents are in 
place:  
1. The main REC approval (if applicable),  
2. HRA approval  
3. Final sponsorship and host site confirmation of capacity and capability 
All participants who wish to enter the study will be approached by the local Community Foot Protection 
Team and written consent taken. Potential participants will have the opportunity to ask any questions 
they have prior to giving consent. Patient information sheets will be available as part of the consenting 
process.  
10.0 STUDY PROCEDURES 

 
 
 
 
 
 
 
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WWPP2 PAM RCT Protocol V1.4 12.06.2024 Protocol No: WWPP2.001 
 
10.1 
INFORMED CONSENT 
Informed consent from the participant will be obtained in clinic following provision of written 
information to the potential participant. Any queries the potential participant may have should be 
addressed by delegated and trained members of the local study team.  
 
The information supplied to the potential participant will include a statement that they are under no 
obligation to enter the trial and that they can withdraw at any time, without having to give a reason. 
 
 
10.2 SCHEDULE OF EVENTS 
 
Path Active 
Screening 
(Pre-
enrolment 
assessment) 
Active phase 0 - 84 days.  
Final visit 
Visit No: 
1 
2 
3 due to 
alert/concern 
4 
Form Number 
F01, F02, F03, 
F04, F05 
F06               
F06 
F07 (F09) 
F08 
TIMING 
Pre-
Assessment 
Day 0 Path 
Active Group 
Day 0 Control 
Group 
When required  
Week 12  (Day 
84) 
Window of 
flexibility for 
timing of visits: 
 - 7 days 
  
  
1 day 
  +7 days 
 
Randomisation 
  
Randomisation 
  
  
 
Informed Consent 
X 
  
  
  
  
 
Medical History or 
change to 
medication 
X 
  
  
X 
  
 
Eligibility 
confirmation 
X 
  
  
X 
  
 
Feet Assessment 
Neuropathy 
X 
  
  
  
  
 
Feet Assessment 
Vascular Doppler 
X 
  
  
X 
  
 
Adverse Events 
review (unless 
reported prior to 
visit) 
  
  
  
X 
X 
 
Questionnaire 
  
X 
X 
  
X 
 

 
 
 
 
 
 
 
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WWPP2 PAM RCT Protocol V1.4 12.06.2024 Protocol No: WWPP2.001 
 
EQ-5D-5L 
  
X 
X 
  
X 
 
Path Active insole 
fitting 
  
X 
  
  
  
 
Daily Dashboard 
Review by Clinical 
Team 
  
X 
  
  
  
 

 
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PAM RCT Protocol V1.4 12.06.2024 Protocol No: WWPP2.001 
 
11.0 
ADVERSE AND SERIOUS ADVERSE EVENTS 
11.1 
GENERAL DEFINITIONS 
An Adverse Event (AE) is any untoward medical occurrence in a patient or a clinical trial 
subject which does not necessarily have a causal relationship with the device/procedure. 
A Serious Adverse Event (SAE) is an untoward occurrence that: 
- 
Is fatal 
- 
Is life threatening 
- 
Requires hospitalisation or prolongation of existing hospitalisation 
- 
Results in persistent or significant disability 
- 
Consists of a congenital anomaly or birth defect 
- 
Is otherwise considered medically significant by the Investigator 
 
Medical and scientific judgement must be exercised in deciding whether an event is serious. There 
characteristics/consequences must be considered at the time of the event and do not refer to an 
event which hypothetically may have caused one of the above. All potential intervention-related AEs 
(such as falls and consequent injuries related to wearing the insoles) will be investigated and subject 
to expedited reporting to the REC.  
12.0 OPERATIONAL DEFINITIONS OF (S)AES 
12.0.1 Expected (S)AEs - Not Reportable 
This is a trial in a patient population with high levels of morbidity and co-morbid diseases and as such 
in this patient population, acute illness resulting in hospitalisation, new medical problems and 
deterioration of existing medical problems are expected.  
 
In recognition of this, events fulfilling the definition of an adverse event or serious adverse events will 
not be reported in this study unless they are classified as ‘related’. 
 
          12.0.2 Expected (S)AEs - Standard Reporting 
 
The following AEs and SAEs are expected within the patient study population and will be reported 
from randomization to trial completion on standard Case Report Forms (CRFs) where the device is not 
a factor in the event:  
 
• Death  
• Hospital admission 

 
 
 
 
 
 
 
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WWPP2 PAM RCT Protocol V1.4 12.06.2024 Protocol No: WWPP2.001 
 
•  nstitutionalisation  
 
As these events are expected within the study population they will not be subject to expedited 
reporting to the main REC. 
 
12.2 
RESPONSIBILITIES 
 
Community Foot Protection Team: 
• 
Checking for SAEs when participants attend following an alert from Path Active or there is 
concern from either Path Active Group or Control Group participants 
• 
Judgement in assigning: 
- Seriousness 
- Relatedness 
- Expectedness 
• 
To ensure all SAEs are recorded and reported to the CI within 24 hours of becoming aware and 
to provide further follow-up information as soon as available. 
CI or delegate: 
• 
Assign relatedness and expected nature of SAEs where it has not been possible to obtain local 
assessment. 
• 
Undertake SAE review. 
• 
Review all events assessed as Related / Unexpected in the opinion of the CI prior to reporting 
to the main REC. 
13.0 
DATA MANAGEMENT AND QUALITY ASSURANCE 
13.1 
CONFIDENTIALITY 
The study will abide by the Caldicott Principles, the Data Protection Act 2018 and General Data 
Protection Regulations for reviewing and managing personal data. All data will be kept confidential, 
stored appropriately and anonymised in as far as is possible. As with standard clinical practice, 
confidentiality may need to be broken if participants or others are at serious risk. This will be 
explained to participants when they consent to participate in the project. 
 
All participants will be given a study number, allocated sequentially by the clinical team. The study will 
comply with the General Data Protection Regulation (GDPR) which requires data to be anonymised as 
soon as it is practical to do so. Data will be analysed anonymously.  
 
The CRF  ill not bear the subject’s name or other directly identifiable data. The subject’s trial 
Identification Number (ID) only, will be used for identification. Participant identifiable information (e.g. 
the signed consent form) will be kept with the study number securely by local study teams, in case of 

 
 
 
 
 
 
 
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WWPP2 PAM RCT Protocol V1.4 12.06.2024 Protocol No: WWPP2.001 
 
the unlikely requirement for breaking confidentiality. This list matching identifiable participant 
information and study numbers will not be kept outside of the local study team. 
 
      13.2 DATA COLLECTION 
Data Collection will be via a paper CRF complied by the study team. Any data eg spreadsheet of 
participants, will be processed via NHS IT systems and stored in secure network folders.   
 
 
13.3 DATA HANDLING AND ANALYSIS 
CRFs will be completed on paper. Data collected will be stored on secure server and in excel files.  
 
Study documents (paper and electronic) containing details of demographic data, documentation of 
inclusion and exclusion criteria, and medical history will be retained for a period of 5 years following 
the end of the study 
 
 
13.4 TRANSFERRING/TRANSPORTING DATA  
If data transfer is required, it will only be transferred via secure nhs.net email and will be anonymised.   
14.0 
ARCHIVING 
During the course of research, all central records are the responsibility of the Principle Investigators 
and must be kept in secure conditions. The PIs will have responsibility for storage of consent forms and 
a list of patient identifiers with study numbers. The PIs will archive the trial essential documents 
generated at the site for the agreed archiving period in accordance with the signed Clinical Trial Site 
agreement. 
 
The trial essential documents along with the trial database will be archived in accordance with the 
sponsor. The agreed archiving period for this trial will be 5 years.  
 
 
 
 
 
 
 
15.0 ENDPOINT DESIGN  

 
 
 
 
 
 
 
Podiatry Department 
Pond Street 
London  
NW3 2QG 
Tel: 020 7794 0500 
 
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15. 1 ENDPOINTS 
15.1.1 
PRIMARY ENDPOINTS 
• Day 84 all participants will be asked to complete a health-related quality of life 
questionnaire and a questionnaire regarding patient experience and, for the Path Active 
Group, use of the device and suggested improvements with the device and associated 
‘app’.  
• 
To model any reduction in carbon footprint due to ulcer prevention.  
  15.1.2  
SECONDARY ENDPOINTS 
• 
      At end of study review all alerts from Path Active and responses to the alerts. Was ulceration  
       prevented? Were there any conflicting outcomes from device use?   
 
15.2 
ANALYSIS PLANS 
 
15.2.1  PRIMARY ENDPOINT ANALYSIS 
Day 84; Data  ill be analysed to determine the effectiveness of ‘Path Active’ compared with                 
               standard podiatry review.   
              Questionnaires will be reviewed for QoL outcomes and patient experience.    
                
 
15.2.2 SECONDARY ENDPOINT ANALYSIS 
 
Day 84; Alerts from Path Active will be analysed to assess a base level of sensitivity and 
specificity.  
16.0 
DIRECT ACCESS TO SOURCE DATA 
The Community Foot Protection Teams will permit trial-related monitoring, audits, REC review, and 
regulatory inspection(s), providing direct access to source data/documents. Trial participants are 
informed of this during the informed consent discussion. Participants will be asked to consent to 
provide access to their medical records. 
 
 
 
 
17.0 
ETHICS AND GOVERNANCE REQUIREMENTS 

 
 
 
 
 
 
 
Podiatry Department 
Pond Street 
London  
NW3 2QG 
Tel: 020 7794 0500 
 
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Before Community Foot Protection Teams can enrol patients into the trial, the Chief Investigator must 
ensure written permission to proceed has been granted by that Trust Research & Development 
Department (R&D).  
The site must conduct the trial in compliance with the protocol as agreed by the Sponsor and, which 
was given favourable opinion by the Research Ethics Committee (REC) and the Health Research 
Authority (HRA) where applicable.  
 
The Principle Investigators will be provided (via the Sponsor) with file indexes TMF Index 
RLFRDDOC0013 and ISF index RFLRDOC0003 for use with SOP019 ‘Preparation and  aintenance of the 
Site File – and SOP05  ‘Preparation and  aintenance of the Trial  aster File’.  The CI will be responsible 
for the maintenance of the TMF and may delegate the responsibility of ISF file maintenance to the PI at 
each participating site. 
 
Within 90 days after the end of the trial, the CI and Sponsor will ensure that the REC is notified that the 
trial has finished.  If the trial is terminated prematurely, those reports will be made within 15 days after 
the end of the trial.  
 
The CI will supply an End of Study report of the clinical trial to the REC within one year after the end of 
the trial. The sponsor can provide an End of study Report template RFLRDDOC0005 
 
          17.1 DEFINITION OF THE END OF TRIAL 
 
The last patient completing day 84 of the trial.  
 
 
17.2 ANNUAL PROGRESS REPORTS (APRs) 
 
The Chief Investigator will prepare the APR in accordance with the RFL R&D Office’s SOP 056 ‘Annual 
Progress Reports’. Following review by the sponsor the report will be sent to the REC. The APR is due 
for submission annually within 30 days of the anniversary date on which the favourable opinion was 
given by the Ethics committee, until the trial is declared ended. 
17.3 PROTOCOL COMPLIANCE  
 
Any Protocol Deviations, Violations will be documented using the deviation reporting form (Form 10 
WWPP2 Protocol Deviation) and processed according to R&D OFFICE SOP 032 
 
The CI will notify the Sponsor immediately of any case where there exists a possible occurrence of a 
violation of the protocol or a breach of Data protection.   
18.0 
FINANCE 

 
 
 
 
 
 
 
Podiatry Department 
Pond Street 
London  
NW3 2QG 
Tel: 020 7794 0500 
 
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SBRI Healthcare Selection Panel. Ref SBRIH22P2006 
19.0 
PEER REVIEW 
The documents have been reviewed by the study team, Patient group (PPIE), Sponsor (WWP) and 
Royal Free Hospital R&D Committee.  
 
20.0 
PUBLIC AND PARTICIPANT INVOLVMENT 
Patients have completed questionnaires regarding the study and use of the device. Also a patient 
group at the Royal Free Hospital have discussed the study and use of the device. Both questionnaires 
and patient group discussion where favourable of the device and the study.   
21.0 
INDEMNITY 
Normal NHS-indemnity processes apply, as documented in HSG(96)48. This covers negligent harm 
during the study, and covers NHS staff, medical academic staff with honorary contracts, and those 
conducting the study. NHS indemnity does not offer no-fault compensation and is unable to agree in 
advance to pay compensation for non-negligent harm. The sponsoring company will provide 
indemnity for the management of the study via their liability insurance.  
22.0 
IP AND DEVELOPMENT POLICY 
Intellectual property may be generated from this study and will remain the property of Walk With Path.   
23.0 
PUBLICATION AND DISSEMINATION POLICY 
Publication: “Any activity that discloses, outside of the circle of trial investigators, any final or interim 
data or results of the Trial, or any details of the Trial methodology that have not been made public by 
the Sponsor including, for example, presentations at symposia, national or regional professional 
meetings, publications in journals, theses or dissertations.” 
All scientific contributors to the Trial have a responsibility to ensure that results of scientific interest 
arising from Trial are appropriately published and disseminated. The Sponsor has a firm commitment 
to publish the results of the Trial in a transparent and unbiased manner without consideration for 
commercial objectives.  
To maximise the impact and scientific validity of the Trial, data shall be consolidated over the duration 
of the trial, reviewed internally among all investigators and not be submitted for publication 

 
 
 
 
 
 
 
Podiatry Department 
Pond Street 
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NW3 2QG 
Tel: 020 7794 0500 
 
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WWPP2 PAM RCT Protocol V1.4 12.06.2024 Protocol No: WWPP2.001 
 
prematurely. Lead in any publications arising from the Trial shall lie with the Sponsor in the first 
instance.  
 
24.0 STATEMENT OF COMPLIANCE  
The trial  ill be conducted in compliance  ith the protocol, Sponsor’s Standard Operating Procedures 
(SOPs), GCP and the applicable regulatory requirement(s). 
 
The study conduct shall comply with all relevant laws of the EU if directly applicable or of direct effect 
and all relevant laws and statutes of the UK country in which the study site is located including but not 
limited to, the Human Rights Act 1998, the Data Protection Act 1998,  ICH GCP, the World Medical 
Association Declaration of Helsinki entitled 'Ethical Principles for Medical Research Involving Human 
Subjects' (2008 Version), the NHS Research Governance Framework for Health and Social Care (Version 
2, April 2005).    
 
This study will be conducted in compliance with the protocol approved by the REC and according to 
GCP standards. No deviation from the protocol will be implemented without the prior review and 
approval of the Sponsor and REC  
 
25.0 REFERENCES  
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. 
 
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. PMID: 28614678. 
 
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; 
PMCID: PMC7317473. 
 
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. 
 

 
 
 
 
 
 
 
Podiatry Department 
Pond Street 
London  
NW3 2QG 
Tel: 020 7794 0500 
 
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Sealed Envelope Ltd. 2012. Power calculator for binary outcome superiority trial. [Online] Available 
from: https://www.sealedenvelope.com/power/binary-superiority/ [Accessed Tue Jan 02 2024]. 
 
 
 
26.0 
APPENDICIES  
Appendix 1 
 
Path Active 
Manual_v3.pptx (2).p