Quantification and Characterization of Foot Postoperative Edema

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.

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Key information

Conditions

Surgery--Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Polyclinique Saint Roch, Montpellier, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optical scanner

Device

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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Clinique MEGIVAL

Other

Registry information

Official study title

Quantification and Characterization of Foot Postoperative Edema - Bicentric Prospective Study

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Jan 13, 2022
Registry last updated: Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed