Quantification and Characterization of Foot Postoperative Edema

Surgery--Complications Clinical Trial

Official title:

Quantification and Characterization of Foot Postoperative Edema - Bicentric Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05190835
• Other study ID #: 2021-A01802-39
• Status: Completed
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: November 15, 2023

Study information

• Verified date: February 2024
• Source: Clinique MEGIVAL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 15, 2023
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery--Complications

Intervention

Device:
• Optical 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.

Locations

Country	Name	City	State
France	Polyclinique Saint Roch	Montpellier
France	Clinique MEGIVAL	Saint-Aubin-sur-Scie

Sponsors (1)

Lead Sponsor	Collaborator
Clinique MEGIVAL

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the change of volume of an operated foot to evaluate the edema.	Change of volume of the foot from Day 0	Day 0 before surgery, Day 8 after surgery
Primary	Evaluate the change of volume of the edema of an operated foot during the 6 months after surgery		Day 21, Day 45, Month 3 and Month 6 after surgery