An interventional study of Medially wedged ortheses in Hyperpronation, Overpronation and Pes Planus, sponsored by University of Milan. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-06-03.
Sponsored by University of Milan · Not applicable, Interventional, and Treatment
Foot hyperpronation is a common postural condition that can lead to pain, deformities (such as hallux valgus), and muscular issues. This problem is especially relevant among adults who spend long hours standing, such as healthcare workers. Custom-made foot orthoses with a medial wedge have proven effective in improving comfort and correcting certain biomechanical alterations, even in asymptomatic individuals.
The study described has two main objectives:
173 studies on the registry are indexed under Flatfoot; 44 are open to participants now.
This study's planned enrollment of 52 is above the median of 40 across 122 interventional studies indexed under Flatfoot.
Browse Flatfoot studies →University of Milan is the lead sponsor of 183 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
To be recruited the partecipants of the study have been visited and their overpronation foot condition has been assessed. Then they will answer the FHSQ at T0. They will have to wear medially wedged ortheses for the duration for 3 months and then be re-assessed by a second evaluation using the FHSQ. Using GAITLAB (from BTS S.p.a) the partecipants' foot condition (calcaneovalgus foot) will be assessed while wearing and not the professional footwear.
Device: Medially wedged ortheses
3 month long wear of medially wedged ortheses. Ortheses have to be worn for 6 to 8 hours daily during work shifts.
Also known as: Wedged ortheses
FHSQ
Assessment and description of the clinical conditions of the partecipants
Time frame: 3 months
GAITLAB
Assessment of the partecipants' foot condition (calcaneovalgus foot) while wearing and not the professional footwear.
Time frame: Baseline
GAITLAB
Assessment of medial plantar support, performed in a static position using a baropodometric platform.
Time frame: Baseline
GAITLAB
Assessment of pressure on the metatarsal heads, performed in a static position using a baropodometric platform, barefoot.
Time frame: Baseline
Plan to share: Undecided — Decision not already taken
Started May 2025 (actual). Primary completion is estimated for May 2026, 11 months after the start.
Of 89 non-industry interventional studies with no phase under Flatfoot, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 15. This study's planned 11 months is above that.
Counting every sponsor, half of 89 studies reached it within 7 months; a quarter within 2 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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