Flexible Flatfoot or Pes PlanusNCT07389343
Effect of a Semirigid Foot Insole in Flexible Pes Planus
A study testing Foot Insole in people with Flexible Flatfoot or Pes Planus, run by Fatma El Zahraa at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Flexible Flatfoot or Pes Planus
- What is being tested?
- Foot Insole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Aug 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
October 6 University Hospital
Giza
Fatma Elzahraa A ElBayomi, MSc degree, +201140015529, fatmaelzahraaelbayomi@gmail.com
Mona M Ibrahim, Asst Prof., +201004046183, mona.ibrahiem@pt.cu.edu.eg
About this study
Official title: Immediate Effect of a Semirigid Foot Insole on Radiological Foot Angles 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.
Read the detailed description
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
- Conditions
- Flexible Flatfoot or Pes Planus
- Being tested
- Foot Insole
- Keywords
- "Foot insole" and "Flexible flatfoot" and "radiological foot angles"
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot InsoleOther
Designed Semirigid foot insole
| Study group | Role | What they receive |
|---|---|---|
| Semirigid foot insole | Experimental | A semi-rigidly designed foot insole will be used to investigate the correction provided for flat-foot angles. Receives: Other: Foot Insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological foot angles
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start27 Aug 2025
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexible Flatfoot or Pes PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatma El Zahraa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fatma El Zahraa, Cairo University
- Investigators
- Fatma Elzahraa A ElBayomi, MSc degree, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389343
- Sponsor's protocol ID
- Fatma-PhD
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Obtaining the patient privacy, however the data will be available with the original author uopn request
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of a Semirigid Foot Insole on Radiological Foot Angles in Flexible Pes Planus
- ClinicalTrials.gov ID
- NCT07389343
- Acronym / sponsor ID
- Fatma-PhD
- Conditions
- Flexible Flatfoot or Pes Planus
- Keywords
- "Foot insole" and "Flexible flatfoot" and "radiological foot angles"
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fatma El ZahraaUniversity, hospital or other
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semirigid foot insole | Experimental | Other: Foot InsoleA semi-rigidly designed foot insole will be used to investigate the correction provided for flat-foot angles. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foot InsoleDesigned Semirigid foot insole | Other | Semirigid foot insole |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No. Obtaining the patient privacy, however the data will be available with the original author uopn request
Related trials for Flexible Flatfoot or Pes Planus
Recruiting
Effects of Hip-Based Versus Knee-Based Exercises on Medial Longitudinal Arch, Dynamic Balance, and Muscle Strength in Flexible Flatfoot
Flexible Flatfoot, Flexible Flatfoot or Pes Planus
Not yet recruiting
Calcaneal Lengthening Osteotomy With Locking Wedge Plate Versus Synthetic PEEK Cage Interposition for Symptomatic Flexible Pes Planovalgus Foot Deformity in Adolescents
Flexible Flatfoot or Pes Planus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fatma Elzahraa A ElBayomi, MSc degree principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot Insole in people with Flexible Flatfoot or Pes Planus, run by Fatma El Zahraa at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma Elzahraa A ElBayomi, MSc degree (+201140015529, fatmaelzahraaelbayomi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.