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Trials / Completed

CompletedNCT05190835

Quantification and Characterization of Foot Postoperative Edema

Quantification and Characterization of Foot Postoperative Edema - Bicentric Prospective Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
Clinique MEGIVAL · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEOptical 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.

Timeline

Start date
2022-01-15
Primary completion
2023-10-15
Completion
2023-11-15
First posted
2022-01-13
Last updated
2024-02-07

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT05190835. Inclusion in this directory is not an endorsement.

Quantification and Characterization of Foot Postoperative Edema (NCT05190835) · Clinical Trials Directory