Surgery--ComplicationsNCT05190835
Quantification and Characterization of Foot Postoperative Edema
A study testing Optical scanner in people with Surgery--Complications, run by Clinique MEGIVAL at 2 sites in France.
Trial summary
In foot surgery, postoperative edema is a complication making the postoperative outcome quite uncertain as to the rehabilitation of the patient. The evolution of this edema is unknown ... The means of "mastering" this edema are empirical, with little study other than cryotherapy and restraint. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery--Complications
- What is being tested?
- Optical scanner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Jan 2022to 15 Nov 2023
- 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
- Major patient
- Patient operated on forefoot surgery
- Patient having given informed consent
- For female patients of childbearing age, not to be pregnant or likely to be during the study, not to be breastfeeding
Who cannot join
- Minor patient
- Patient deprived of his liberty or under guardianship
- Patient operated on for surgery of the forefoot other than 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
- Vulnerable people according to article L1121-6 of the CSP
Trial locations and contacts
2 sites in 1 country.
France2 sites
Polyclinique Saint Roch
Montpellier, 34070
Clinique MEGIVAL
Saint-Aubin-sur-Scie, 76550
About this study
Official title: Quantification and Characterization of Foot Postoperative Edema - Bicentric Prospective Study
In foot surgery, postoperative edema is a complication making the postoperative outcome quite uncertain as to the rehabilitation of the patient. The evolution of this edema is unknown ... The means of "mastering" this edema are empirical, with little study other than cryotherapy and restraint. This study aims to study postoperative edema in a cohort of patients undergoing forefoot surgery. The follow-up will be prospective with measurement of the volume of the foot using an optical technique, during the various follow-up consultations between Day 8 and Month 6 postoperative.
- Conditions
- Surgery--Complications
- Being tested
- Optical scanner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical scannerDevice
During the visits (Day 0 before surgery, Day 8, Day 21, Day 45, Month 3 and Month 6 after surgery), a measurement of the volume and the perimeter of the patient's two feet is carried out (operated foot and control foot). The edema is measured by a non-invasive method using an optical scanner (camera + laser scanning). The image processing software accompanying this tool has an automatic calculation of the volumes and the different perimeters of the foot. The measurement time by the scanner is less than 4 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Hallux surgery | Other | These are patients operated on for hallux without change of strategy compared to current care Receives: Device: Optical scanner |
| Metatarsal paddle surgery | Other | These are patients operated on for metatarsal paddle without change of strategy compared to current care Receives: Device: Optical scanner |
| Hallux and metatarsal pallet surgery | Other | These are patients operated on for hallux and metatarsal paddle without change of strategy compared to current care Receives: Device: Optical scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the change of volume of an operated foot to evaluate the edema.
Change of volume of the foot from Day 0
Measured: Day 0 before surgery, Day 8 after surgery
Evaluate the change of volume of the edema of an operated foot during the 6 months after surgery
Measured: Day 21, Day 45, Month 3 and Month 6 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start15 Jan 2022
- Primary completion15 Oct 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery--ComplicationsStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique MEGIVAL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190835
- Sponsor's protocol ID
- 2021-A01802-39
- Status last verified
- Feb 2024
- First submitted
- 10 Dec 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification and Characterization of Foot Postoperative Edema - Bicentric Prospective Study
- ClinicalTrials.gov ID
- NCT05190835
- Acronym / sponsor ID
- 2021-A01802-39
- Conditions
- Surgery--Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Clinique MEGIVALUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 13 Jan 2022 (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.
In foot surgery, postoperative edema is a complication making the postoperative outcome quite uncertain as to the rehabilitation of the patient. The evolution of this edema is unknown ... The means of "mastering" this edema are empirical, with little study other than cryotherapy and restraint. This study aims to study postoperative edema in a cohort of patients undergoing forefoot surgery. The follow-up will be prospective with measurement of the volume of the foot using an optical technique, during the various follow-up consultations between Day 8 and Month 6 postoperative.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hallux surgery | Other | Device: Optical scannerThese are patients operated on for hallux without change of strategy compared to current care |
| Metatarsal paddle surgery | Other | Device: Optical scannerThese are patients operated on for metatarsal paddle without change of strategy compared to current care |
| Hallux and metatarsal pallet surgery | Other | Device: Optical scannerThese are patients operated on for hallux and metatarsal paddle without change of strategy compared to current care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Major patient
- Patient operated on forefoot surgery
- Patient having given informed consent
- For female patients of childbearing age, not to be pregnant or likely to be during the study, not to be breastfeeding
Key exclusion criteria (6 listed)
- Minor patient
- Patient deprived of his liberty or under guardianship
- Patient operated on for surgery of the forefoot other than 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 |
|---|---|---|
| Optical scannerDuring the visits (Day 0 before surgery, Day 8, Day 21, Day 45, Month 3 and Month 6 after surgery), a measurement of the volume and the perimeter of the patient's two feet is carried out (operated foot and control foot). The edema is measured by a non-invasive method using an optical scanner (camera + laser scanning). The image processing software accompanying this tool has an automatic calculation of the volumes and the different perimeters of the foot. The measurement time by the scanner is less than 4 seconds. | Device | Hallux and metatarsal pallet surgery, Hallux surgery, Metatarsal paddle surgery |
Primary outcome
Evaluate the change of volume of an operated foot to evaluate the edema.
Time frame: Day 0 before surgery, Day 8 after surgery
Change of volume of the foot from Day 0
Evaluate the change of volume of the edema of an operated foot during the 6 months after surgery
Time frame: Day 21, Day 45, Month 3 and Month 6 after surgery
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 7 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical scanner in people with Surgery--Complications, run by Clinique MEGIVAL at 2 sites 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 4 inclusion and 6 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 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Evaluate the change of volume of an operated foot to evaluate the edema. (time frame: Day 0 before surgery, Day 8 after surgery). The study lists 2 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 7 Feb 2024.