Insole Optimization for Rheumatoid Arthritis Patients

NCT ID: NCT07321340

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-12-31

Brief Summary

Rheumatoid arthritis affects 0.5% of the population, often leading to foot deformities and pain that are difficult to treat. Management is based on controlling inflammation, adapting footwear and using custom-made insoles, all of which have proven effective. The aim of this research is to build a digital model of plantar pressures based on CT scans, in order to optimize orthopedic insoles. The study will analyze the gait of patients with and without standard insoles to identify mechanical criteria correlated with pain. The ultimate aim is to design optimized insoles, validated by a new gait analysis.

Conditions

Rhumatoid Arthisis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

3D imaging (foot CT scan)

foot CT scan

Group Type: OTHER

gait analysis from 3D imaging (ENSENSO)

Intervention Type: OTHER

gait analysis from 3D imaging (ENSENSO) on patients with bone geomtry 3D imaging

Interventions

gait analysis from 3D imaging (ENSENSO)

gait analysis from 3D imaging (ENSENSO) on patients with bone geomtry 3D imaging

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with rheumatoid arthritis according to 2010 ACR/EULAR criteria
• RA at low activity level according to DAS28≤3.2
• Patient with mechanical forefoot involvement on walking and improved by foot orthoses.

Exclusion Criteria

• Patients with a contraindication to a bone scan
• Patients with neurological gait disorders that interfere with gait analysis
• Exclude particularly protected persons:

• Pregnant women, parturients, nursing mothers;
• Persons deprived of liberty, hospitalized without consent, hospitalized for purposes other than research;
• Minors;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SAINBIOSE

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu de Saint-Etienne

Saint-Etienne, , France

Countries

France

Central Contacts

Hubert MAROTTE, MD PhD

Role: CONTACT

hubert.marotte@chu-st-etienne.fr

(0)4 77 12 76 49 ext. +33

Florence RANCON, CDP

Role: CONTACT

florence.rancon@chu-st-etienne.fr

(0)477829458 ext. +33

Facility Contacts

Hubert MAROTTE, MD PhD

Role: primary

hubert.marotte@chu-st-etienne.fr

(0)4 77 12 76 49 ext. +33

Other Identifiers

ANSM

Identifier Type: OTHER

Identifier Source: secondary_id

25CH256

Identifier Type: -

Identifier Source: org_study_id