Status:
TERMINATED
Impact of a Dynamic Dressing in the Management of Unoperated Hallux Valgus (DYNHALLUX)
Lead Sponsor:
Centre Hospitalier Annecy Genevois
Conditions:
Hallux Abductovalgus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Hallux Valgus (HV) is a lateral deviation of the big toe. HV is a deformity of the forefoot centered on the 1st radius (1st metatarsal and big toe). This deformation is characterized by: * a big toe ...
Detailed Description
The hypothesis of the study is that a dynamic joint dressing, associated with a rigid orthopedic insole, would make it possible to "reverse" the deformation and re-focus the angles of deformation of t...
Eligibility Criteria
Inclusion
- hallux valgus on at least one foot theoretically requiring surgical management within 12 months
- reducible hallux valgus
- wearing custom-made orthopedic insoles made by a biomechanical podiatrist - SHORE ≥ 65 - for at least 2 months at the time of inclusion
- beneficiary of a social security scheme
- informed of the study and signed informed consent form
Exclusion
- History of hallux valgus correction surgery on the affected foot
- History of traumatic lesion of the M1-P1 metatarsophalangeal joint of the affected foot
- Skin pathology limiting or contraindicating the possibility of dressings according to the judgment of the investigator (eg dyshidrotic eczema, psoriasis or other problematic skin damage located in the foot)
- Acute bursitis
- Clinical and / or radiological stage 1 or more osteoarthritis according to the criteria of Kellgren and Lawrence
- Non-stabilized diabetes and / or diabetes with micro / macrovascular complications
- Patients with neuropathy
- History of gout
- History of rheumatic pathology
- Obliterating arteriopathy of the lower limbs of stage II or more according to the classification of Leriche and Fontaine
- Pregnant woman
- Patients under tutorship or curatorship
- Patients under legal protection
- Patients who do not understand French
Key Trial Info
Start Date :
April 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04732897
Start Date
April 22 2021
End Date
January 25 2022
Last Update
July 22 2022
Active Locations (1)
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1
Centre Hospitalier Annecy Genevois
Metz-Tessy, France, 74374