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Quantification and Characterization of Foot Postoperative Edema

Quantification and Characterization of Foot Postoperative Edema - Bicentric Prospective Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05190835
Enrollment
100
Registered
2022-01-13
Start date
2022-01-15
Completion date
2023-11-15
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery--Complications

Brief 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. 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.

Interventions

DEVICEOptical scanner

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.

Sponsors

Clinique MEGIVAL
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the change of volume of an operated foot to evaluate the edema.Day 0 before surgery, Day 8 after surgeryChange 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 surgeryDay 21, Day 45, Month 3 and Month 6 after surgery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026