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NCT Number: NCT07389343

Effect of a Semirigid Foot Insole in Flexible Pes Planus

The goal of this clinical trial is to investigate the effect of a semirigid foot insole on radiological angle correction in people with asymptomatic flexible flat feet. The X-ray will be performed while standing barefoot one time and the other while standing on the insole from 2 views.

Recruiting

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This study will be conducted on 30 male and female subjects with flexible pes planus. Clinical diagnosis for flexible pes planus will be made through the navicular drop test (NDT) and the Foot Posture Index (FPI). The study included asymptomatic people with flexible pes planus. If the pain is greater than 3 out of 10 on the numeric pain rating scale in the last 3 months, aged 18-35, and BMI max 29.9 kg/cm². The subjects will be excluded if they have osteoarthritis of the joints of the foot (excluded by x-ray), foot deformities (e.g., hallux valgus), old fractures of the foot, previous injuries to the ankle, or previous surgeries to the lower limb. Calcaneal Spur, Foot and Ankle Ligament Tear, Systemic diseases such as rheumatoid arthritis (gouty arthritis, an autoimmune disease) and neurological diseases. The X-ray is the gold standard for assessment of adult-acquired flat foot deformity. Two views are used: anteroposterior (AP) and lateral views. A ruler and protractor will be used for manual measurements of X-ray foot. The subject will stand barefoot, and a weight-bearing X-ray will be taken from lateral and AP views once, without an insole, and another photo will be taken with an insole. The subject will stand barefoot, and a weight-bearing X-ray will be taken from lateral and AP views once, without an insole, and another photo will be taken with an insole.

The angles will be measured:

The gathered angles aim to evaluate the alignment of the foot's three arches. In the lateral view, the following angles will be measured and evaluated with without the insole: the lateral talo-1st metatarsal angle, the calcaneal inclination angle, the angle of Hibbs, the calcaneal-5th metatarsal angle, and the navicular height.

In the AP view, the following angles will be measured and evaluated with without the insole: The lateral talo-1st metatarsal angle, Talo-2nd metatarsal angle, The talocalcaneal angle, Talonavicular coverage angle and First-fifth metatarsal angle

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Asymptomatic people with flexible pes planus. If the pain is greater than 3 out of 10 on the visual analog scale in the last 3 months, the patient is considered to have symptomatic flat feet (Mahdiyar et al., 2021).
  • Aged 18-35.
  • BMI max 29.9 kg/cm².

Exclusion criteria

  • Osteoarthritis of the joints of the foot (excluded by x-ray).
  • Foot Deformities (e.g. Hallux Valgus)
  • Old fractures of the foot.
  • Previous injuries to the ankle.
  • Previous surgeries to the lower limb. 6. Calcaneal Spur. 7. Foot and ankle ligaments tear.

8- Systemic diseases such as rheumatoid arthritis. (Gouty arthritis, autoimmune disease) 9. Neurological diseases.

Treatment and study plan

Foot Insole

Other

Designed Semirigid foot insole

Primary outcomes

  1. Radiological foot angles

    Time frame: Immediately after the insole insertion. The radiology will be taken one time barefoot and second time with the insole insertion, and the researcher will measure the foot angles pre- and post-insole to measure the correction.

    In the lateral view,the lateral talo-1st metatarsal angle, the calcaneal inclination angle, the angle of Hibbs, the calcaneal-5th metatarsal angle, and the navicular height.

    In the AP view,The lateral talo-1st metatarsal angle, Talo-2nd metatarsal angle, The talocalcaneal angle, Talonavicular coverage angle and First-fifth metatarsal angle

Study contacts

Contact information is provided by the study sponsor or research team.

Fatma Elzahraa A ElBayomi, MSc degree

CONTACT

[email protected]

+201140015529

Mona M Ibrahim, Asst. Prof.

CONTACT

[email protected]

+201004046183

Sponsors and collaborators

Lead sponsor

Fatma El Zahraa

Other

Registry information

Official study title

Immediate Effect of a Semirigid Foot Insole on Radiological Foot Angles in Flexible Pes Planus

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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