Jun 16, 2026
Physical Activity and Time Spent Wearing Offloading Footwear in People with an Active Diabetes-related Foot Ulcer (MOVE DFU)
This protocol is a draft, published without a DOI.
- Cal Baker1
- 1University of Queensland
- Physical Activity Monitoring
Protocol Citation: Cal Baker 2026. Physical Activity and Time Spent Wearing Offloading Footwear in People with an Active Diabetes-related Foot Ulcer (MOVE DFU). protocols.io https://dx.doi.org/
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Working
We use this protocol and it's working
Created: June 16, 2026
Last Modified: June 16, 2026
Protocol Integer ID: 319235
Keywords: offloading adherence measurement in diabetes, reproducible implementation of physical activity, offloading adherence measurement, activpal monitor on the thigh, physical activity, foot ulcer research, related foot ulcer research, primary activity outcome, offloading adherence in people, living physical activity, offloading footwear, foot ulcer, active diabetes, offloading adherence, dfu observational study procedure, footwear in people, steps per day, clinical data, related foot ulcer, activpal monitor, prescribed offloading, adherence, diabetes, observational study procedure, adherence definition, offloading device, second activpal monitor, routine medical record, posture, activity, clinical outcome, including wound characteristic, healing status
Abstract
Diabetes-related foot ulcers are commonly managed with removable offloading devices, yet clinical outcomes are influenced by both physical activity and adherence to prescribed offloading. This protocol describes the MOVE-DFU observational study procedures for measuring free-living physical activity and offloading adherence in people with active diabetes-related foot ulcers. Participants wear one activPAL monitor on the thigh to measure posture, stepping, and weight-bearing activity, and a second activPAL monitor attached to the prescribed offloading device to estimate whether the device is worn during weight-bearing periods. The protocol outlines participant recruitment, monitor placement, wear instructions, data download procedures, data processing rules, adherence definitions, and planned clinical outcomes. Primary activity outcomes include steps per day and time spent sitting, standing, stepping, and weight-bearing. Offloading adherence is calculated as the proportion of total weight-bearing time during which the offloading device is worn. Clinical data, including wound characteristics and healing status, are collected from routine medical records. This protocol is intended to support reproducible implementation of physical activity and offloading adherence measurement in diabetes-related foot ulcer research and future multisite studies.
Image Attribution
Figure 1, Figure 2: positioning of the ActivPAL on the participant's thigh. The ActivPAL is low profile and water-resistant.
Materials
ActivPAL accelerometer (PAL Technologies, Glasgow, UK), Tegaderm dressing
Safety warnings
There are very limited risks and burdens associated with study participation. Participants are required to wear an activPAL for 2 weeks on their thigh. ActivPALs are water resistant and do not interfere with showering or self-hygiene; however, they cannot be fully submerged in a pool or bath. People with a DFU are instructed not to swim or immerse their body in water due to the increased risk of infection. The ActivPAL fitted to the podiatry prescribed offloading footwear (as part of routine care) does not incur any burdens or risks. There is a chance that an activPAL may fall off between study visits, should it be lost this will not incur a cost to the participant. If the ActivPAL falls off and the participant notices it come off they can return it at their next routine visit or they can contact the study researchers who can organise for it to be retrieved at no cost to the participant. There is a small risk of localised and mild irritation from the Tegaderm dressing used to fit the ActivPAL to the person. Should this occur, the participant can remove the dressing immediately which will resolve any irritation.
INFORMATION AND CONSENT
Informed consent in the form of signature on the PCF will be taken by a RPAH staff member or study researcher. Potential participants will be provided the PIS and PCF after being screened for eligibility by an RPAH staff member. Potential participants can review the documents and consent to participate in the study by signing the PCF. Study researchers (such as Dr Callum Baker and A/Prof Nathan Johnson) are frequently at RPAH as part of their honorary roles with NSW Health and can conduct informed consent with participants and answer potential participants questions face to face. Dr Baker’s contact details are also available on the PIS and potential participants are able to make contact via email or call in their own time.
Signed PCF will be kept on site at RPAH in a locked records compactor with access only to study researchers. Signed PCFs’ will be kept for the duration required according to NHMRC.
PATIENT WITHDRAWAL
If a participant decides to withdraw, they can do so at any time without penalty or loss of benefits to which they are otherwise entitled. The PIS informs the participants that they have the right to withdraw from the study at any time, without it having any effect on their current or future relations with the staff at SLHD or other institutions associated with this provider and are not obliged to state their reasons for withdrawal. Upon withdrawal, participants can request to have collected data (ActivPAL data) deleted.
If the Participant wishes to withdraw they can contact the site investigators (contact details are provided on this PIS). After withdrawal, the participant will be asked to return the ActivPALs at their next routine care visit. The date of withdrawal and reason will be collected (if a reason is given). Data collected prior to withdrawal will be analysed unless the participants wishes for it to be deleted (this is detailed on the PIS). The patient will still be managed in the service as per standard clinical practice.
OUTCOMES
Primary Outcomes: physical activity levels: Steps per day, time spent sitting/standing/lying. Time spent wearing offloading footwear (total time per day and percentage of weight bearing time)
Data from the thigh- and footwear-mounted activPAL devices will be synchronised using timestamp data. Total weight-bearing time (hours/day) will be computed from the thigh activPAL’s posture classification (standing + stepping). Time wearing offloading footwear (hours/day) will be determined from periods of movement detected by the footwear-mounted activPAL. Percentage adherence (% of weight-bearing time in footwear) will then be calculated as: (time wearing footwear ÷ total weight-bearing time) × 100.
Secondary outcomes:
demographics: age, gender, height, weight (as described in participant’s medical records).
wound outcomes: baseline wound classification information (WiFI, PEDIS, and SINBAD), date of ulceration, and wound healing outcomes; percent wound closure at 4 and 12 weeks, proportion of patients’ whose DFU healed (completely) at 4 and 12 weeks (as described in medical records).
Glucose control and diabetes duration: HbA1c, and diabetes type and duration (as described in medical records).
DATA COLLECTION
FORMS AND PROCEDURES FOR COLLECTING DATA
Patients will be seen as per standard clinical practice in the High Risk Foot Services at RPAH where data (apart from activpal data) for the study is collected as part of standard medical care and entered into the EMR.
Clinical outcome data will be collected from the participant’s EMR as part of standard care. EMR review will continue for up to 6 months after recruitment or until wound healing is confirmed, whichever comes first.
A master code sheet will be stored in SLHD REDcap accessible by SLHD staff (Jess White Project Coordinator 26 Senior Podiatrist SLHD Podiatry). Signed PCFs will be kept on site at RPAH in a locked records compactor with access only to study researchers.
All identifiable data including the unique identifying number, patient name, medical record number, date of birth, gender and scanned consent form will be saved on the Master Code Sheet within SLHD REDCap. De-identified data will be transferred (via a SLHD-approved secure systems such as REDCap Send It or Kiteworks) to the USYD secure and protected research data storage.
Data from ActivPALs will be exported from the device by a study researcher after it has been returned to the iHRFS at the participants next usual care visit. The device does not record GPS locations, it only records accelerometry data (movements that are up, down or sideways over time). ActivPAL data cannot be used to locate a person or identify a person in any way. The export will create a local copy on the study researcher’s password protected laptop which is then immediately uploaded to USYD research data storage. The data on the ActivPAL is de-identified, it does not have participants details (apart from their unique identifying number). The local copy of the ActivPAL data will be immediately deleted from the study researchers laptop after uploading of the data to research data storage. The ActivPAL has the data permanently erased following export of the data.
ANALYSIS PLAN
This is a preliminary longitudinal study with no power calculation possible. The study is not designed to test a between group outcome but to examine current physical activity levels and time spent wearing offloading footwear by a gold standard quantitative measurement so as to establish the magnitude and direction of their associations with healing. Sample size of 40 people should be sufficient to determine this.
Participants will be stratified by wound healing outcomes and comorbid conditions to examine differences in physical activity levels and time spent wearing offloading footwear. To date there is insufficient evidence to conduct a power calculation on these outcomes. This data will be used to inform future studies on these outcomes and will be of great use in determining support appropriate power calculations in future studies.
The primary outcome will be analysed used a cox proportional hazards regression model (primary predictors: physical activity levels as steps per day, offloading footwear adherence as % of time spent wearing prescribed footwear). For this analysis, the event of interest is complete wound healing, defined as the date of full epithelialisation of the ulcer with no drainage as recorded in the EMR. Participants not healed by their final review will be right-censored.
Secondary analysis will examine wound healing rates, predictor correlation and variance estimation and feasibility of data collection as proportion participants with complete data for each outcome and device wear time.
Protocol references
1. Australian Diabetes-related Foot Disease Guidelines, 2022
2. International Working Group on the Diabetic Foot Guidelines, 2023