Foot InjuryNCT06242002
Early Post-operative Monitoring by Sensor of Patients Undergoing Forefoot Surgery
A study testing Set up of sensor in people with Foot Injury, run by Clinique de lEurope a Amiens at 1 site in France.
Trial summary
The goal of this clinical trial is to evaluate the monitoring using a sensor in patients who have undergone forefoot surgery, during the first 7 post-operative days. The monitoring tool has a Global Positioning System (GPS) beacon, a 3-axis accelerometer and a temperature sensor, as well as an "emergency call" button. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Injury
- What is being tested?
- Set up of sensor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing forefoot surgery
- Patient having given informed consent
Who cannot join
- Patient deprived of his liberty or under guardianship
- Patient undergoing surgery other than the forefoot (hallux and lateral toes)
- Patient unable to undergo protocol monitoring for psychological, social, family, geographic or linguistic reasons
- Patient with an underlying or concomitant pathology incompatible with inclusion in the trial, whether psychiatric or somatic
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to evaluate the monitoring using a sensor in patients who have undergone forefoot surgery, during the first 7 post-operative days.
The monitoring tool has a Global Positioning System (GPS) beacon, a 3-axis accelerometer and a temperature sensor, as well as an "emergency call" button.
The main objective it aims to answer are:
- to evaluate the feasibility of post-operative monitoring using this tool
- to evaluate the reliability of the tool
The investigators hope to determine if using this tool can be able to provide patients a "connected" personalized real-time monitoring for follow-up.
Read the detailed description
Currently, patients undergoing forefoot surgery often do so in an outpatient setting and thus spend less and less time in the healthcare establishment in contact with the nursing staff, being increasingly left to themselves at home. The development of telemedicine with real-time information transfer can enable the monitoring of acute or chronic pathologies, thus allowing a link between the patient and the healthcare network, for more personalized monitoring.
Post-operative pain following forefoot surgery is now well controlled, allowing greater patient autonomy despite post-operative footwear. However, the patient's autonomy, locomotor and mobilization capacity are not known.
The investigators therefore propose monitoring the first 7 post-operative days using a sensor in patients who have undergone forefoot surgery. This 7-day period corresponds to the critical period of foot surgery with resumption of post-operative support, lifting of loco-regional anesthesia and return home. This monitoring will be done from discharge from the service until the first post-operative visit. The monitoring will be prospective with non-invasive measurements via an electronic sensor (already used for sporting activities, notably long-distance running). This will be a clinical practice study, with no modification to monitoring or current practices. The monitoring tool has a Global Positioning System (GPS) beacon, a 3-axis accelerometer and a temperature sensor, as well as an "emergency call" button. The recorded parameters will be the number of steps, local temperature and GPS position of the patient. The data will be transmitted via an independent cellular network and to a secure space (username and password) accessible online.
The main objective will be to evaluate the feasibility of post-operative monitoring using this tool. The secondary objectives will be to evaluate the reliability of the tool, to evaluate the transmission of the GPS signal, and to collect the data.
Following this study, the investigators hope to be able to provide patients with real-time monitoring, via alerts received on the smartphone (e.g. icing instructions via the temperature sensor, instructions to reduce locomotor activity, etc.) .
- Conditions
- Foot Injury
- Being tested
- Set up of sensor
- Keywords
- foot, surgery, sensor, post-surgical follow-up
- Medical subject headings
- Foot Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Set up of sensorProcedure or surgery
Surgery is performed as usual for patients needing this medical procedure. At the end, the sensor is set up under the surgical dressing.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | For patients participating to the clinical trial, the sensor will be positioned at the end of the procedure, under the surgical dressing, at ankle level.
This dressing is a definitive dressing which is only removed during the post-operative consultation on day 8, during which the sensor will be removed.
During this 7 days, data from the sensor will be collected every 4 hours. Receives: Procedure: Set up of sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step count
Collecting step count data on the server
Measured: Every 4 hours during 7 days
local temperature
Collecting local temperature data on the server
Measured: Every 4 hours during 7 days
distance traveled (kilometers)
Collecting data on the distance traveled by the patient on the server, (in kilometers). Distance is measured by the global positioning system beacon of the sensor.
Measured: Every 4 hours during 7 days
Secondary outcomes (1)
Patient's satisfaction : questionnaire
Patients satisfaction will be evaluated by a questionnaire with 5 items. 4 items are "yes-no" questions, and the last one is a Likert scale of 5 levels (from "not at all satisfied" to "very satisfied").
Measured: day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start19 Jan 2024
- Primary completion31 Dec 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique de lEurope a Amiens
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242002
- Sponsor's protocol ID
- 2023-A02074-41
- Status last verified
- Feb 2025
- First submitted
- 25 Jan 2024
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Post-operative Monitoring by Sensor of Patients Undergoing Forefoot Surgery
- ClinicalTrials.gov ID
- NCT06242002
- Acronym / sponsor ID
- 2023-A02074-41
- Conditions
- Foot Injury
- Keywords
- foot, surgery, sensor, post-surgical follow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Clinique de lEurope a AmiensOther government
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the monitoring using a sensor in patients who have undergone forefoot surgery, during the first 7 post-operative days.
The monitoring tool has a Global Positioning System (GPS) beacon, a 3-axis accelerometer and a temperature sensor, as well as an "emergency call" button.
The main objective it aims to answer are:
- to evaluate the feasibility of post-operative monitoring using this tool
- to evaluate the reliability of the tool
The investigators hope to determine if using this tool can be able to provide patients a "connected" personalized real-time monitoring for follow-up.
Detailed description
Currently, patients undergoing forefoot surgery often do so in an outpatient setting and thus spend less and less time in the healthcare establishment in contact with the nursing staff, being increasingly left to themselves at home. The development of telemedicine with real-time information transfer can enable the monitoring of acute or chronic pathologies, thus allowing a link between the patient and the healthcare network, for more personalized monitoring.
Post-operative pain following forefoot surgery is now well controlled, allowing greater patient autonomy despite post-operative footwear. However, the patient's autonomy, locomotor and mobilization capacity are not known.
The investigators therefore propose monitoring the first 7 post-operative days using a sensor in patients who have undergone forefoot surgery. This 7-day period corresponds to the critical period of foot surgery with resumption of post-operative support, lifting of loco-regional anesthesia and return home. This monitoring will be done from discharge from the service until the first post-operative visit. The monitoring will be prospective with non-invasive measurements via an electronic sensor (already used for sporting activities, notably long-distance running). This will be a clinical practice study, with no modification to monitoring or current practices. The monitoring tool has a Global Positioning System (GPS) beacon, a 3-axis accelerometer and a temperature sensor, as well as an "emergency call" button. The recorded parameters will be the number of steps, local temperature and GPS position of the patient. The data will be transmitted via an independent cellular network and to a secure space (username and password) accessible online.
The main objective will be to evaluate the feasibility of post-operative monitoring using this tool. The secondary objectives will be to evaluate the reliability of the tool, to evaluate the transmission of the GPS signal, and to collect the data.
Following this study, the investigators hope to be able to provide patients with real-time monitoring, via alerts received on the smartphone (e.g. icing instructions via the temperature sensor, instructions to reduce locomotor activity, etc.) .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Set up of sensorFor patients participating to the clinical trial, the sensor will be positioned at the end of the procedure, under the surgical dressing, at ankle level. This dressing is a definitive dressing which is only removed during the post-operative consultation on day 8, during which the sensor will be removed. During this 7 days, data from the sensor will be collected every 4 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing forefoot surgery
- Patient having given informed consent
Key exclusion criteria (4 listed)
- Patient deprived of his liberty or under guardianship
- Patient undergoing surgery other than the forefoot (hallux and lateral toes)
- Patient unable to undergo protocol monitoring for psychological, social, family, geographic or linguistic reasons
- Patient with an underlying or concomitant pathology incompatible with inclusion in the trial, whether psychiatric or somatic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Set up of sensorSurgery is performed as usual for patients needing this medical procedure. At the end, the sensor is set up under the surgical dressing. | Procedure or surgery | Experimental group |
Primary outcome
Step count
Time frame: Every 4 hours during 7 days
Collecting step count data on the server
local temperature
Time frame: Every 4 hours during 7 days
Collecting local temperature data on the server
distance traveled (kilometers)
Time frame: Every 4 hours during 7 days
Collecting data on the distance traveled by the patient on the server, (in kilometers). Distance is measured by the global positioning system beacon of the sensor.
1 secondary outcome
Patient's satisfaction : questionnaire
Time frame: day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Foot Injury
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Recruiting
Investigating Auto Adjusting Dynamic AFO
Lower Limb; Fusion, Congenital, Lower Limb Fracture
Active, not recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Set up of sensor in people with Foot Injury, run by Clinique de lEurope a Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step count (time frame: Every 4 hours during 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.