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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05190835
Other study ID # 2021-A01802-39
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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