Patients With Foot ProblemsFHSQ-FrNCT06933953
Validation of the Foot Health Status Questionnaire in French Language
A study testing Questionnaires in people with Patients With Foot Problems, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
A French foot health survey showed that 73% of people examined felt pain and 38% don't left their home, which suggest a reduction in their life's quality and autonomy. Developed by Paul Bennett, FHSQ is a foot health-specific self administrated questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Foot Problems
- What is being tested?
- Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2025to Feb 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients coming to IFRES in Alençon (61) France for a pedicure or podiatry appointment,
- Age >= 18
- knowing how to speak, read and write French.
Who cannot join
- 1. Have already taking part in this research before the proposition to get in.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Ifres Ecole de Pedicure Podologie
Alençon
Delphine GUYET, 0661445164 ext. +33, delphine.guyet@unicaen.fr
About this study
Official title: Psychometric Validation of the Foot Health Status Questionnaire in French Language
A French foot health survey showed that 73% of people examined felt pain and 38% don't left their home, which suggest a reduction in their life's quality and autonomy. Developed by Paul Bennett, FHSQ is a foot health-specific self administrated questionnaire. It sensitively detects changes in patients' foot health status, whatever their pathology, across multidimensional concepts of their quality of life. Actually, more than 150 scientific publications have cited it. Reliable and valid, it has already been translated and validated in multiple languages, but not in French. The subject of this study is to validate the translated and cross-cultural adapted French version FHSQ-fr through its psychometric results of validity and reliability. The study follows a 2-stage methodology.
The first, already completed, consisted of (back)translating the Australian FHSQ questionnaire into French by a scientific committee in order to obtain a pre-final version.
The second is to validate this final version using appropriate statistical analysis, including correlations studies with other French validated questionnaires, to determine its psychometric characteristics.
Read the detailed description
To assess validity, 150 volunteers will fill out French validated questionnaires, Foot Function Index (FFI), EuroQuality of life 5D-5L (EQ5D) , Visual Analogic Pain Scale (VAPS), and Short Form 12 Health survey (SF12). They will be evaluated about their pain, morphology, function and posture of their feet as usual at a podiatric school. To assess reliability, 50 respondents from the 150 who didn't receive any treatment after 7 to 10 days, will complete the FHSQ-fr again. It would improve knowledge of the status of foot health and its related quality of life in the general population and those suffering from specific pathologies such as diabetes or rheumatoid arthritis, the effectiveness of certain treatments on the same foot condition, and their evolutions using longitudinal studies in France. At the international, the French future results of studies using this clinimetric tool could be compared with those who come from other countries, and integrated to the Australian author's " Bigdataset" which compares, analyses and predicts more accurately the clinically significant efficacy of a treatment.
- Conditions
- Patients With Foot Problems
- Being tested
- Questionnaires
- Keywords
- Surveys and Questionnaires, FHSQ French translation, Health status, Foot, Validity, Reliability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Patients will complete various questionnaires at J0: FHSQ-Fr, EQ-5D-5L, Foot Function Index, Visual analog pain scale, SF-12.
Patients who needs to come back for a visit at Day 7 (+ 3 days) will complete the FHSQ-Fr questionnaire for a second time
| Study group | Role | What they receive |
|---|---|---|
| Patients with foot problems | Other | Patients will complete many questionnaires : FHSQ-fr, Foot Function Index, EQ-5D-5L, Visual Analog Pain Scale, SF-12 Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal consistency
It is evaluated using Cronbach's alpha coefficient "α", which measures the internal consistency of a set of items, scales or sub-scales for a single clinical dimension. The value of this index is less than or equal to 1, and the closer alpha is to 1, the stronger it is. α" > 0.7 or >0.8 is considered fairly high. However, the coefficient must not be too close to 1, otherwise the items are redundant and duplicate each other.
Measured: Day 0
Temporal stability of patients' questionnaire scores FHSQ-en V 1.02
It is measured by the Intraclass Correlation Coefficient (ICC) and its 95% confidence interval, and/or the Pearson Correlation Coefficient.
By convention, fidelity is said to be:
- Very good if ICC ≥0 91
- Good if 0.9 ≤ ICC ≤ 0.71
- Moderate if 0.70 ≤ ICC ≤ 0.51
- Poor if 0.5 ≤ ICC ≤ 0.31
- Very poor or nil if ICC ≤ 0.3
Measured: Day 0 and day 7
Measurement error
To apply the criterion of good measurement error, the MIC (Minimal Important Change), the SDC (Smallest Detectable Change) or the LoA (Limits of Agreement) load will be calculated using a longitudinal approach based on anchoring.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start31 Mar 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patients With Foot ProblemsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Delphine GUYET, Principal investigator, IFRES of Alençon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933953
- Sponsor's protocol ID
- CHUO-2024-12
- Acronym
- FHSQ-Fr
- Status last verified
- Apr 2026
- First submitted
- 16 Dec 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Burzykowski T, Molenberghs G, Abeck D, Haneke E, Hay R, Katsambas A, Roseeuw D, van de Kerkhof P, van Aelst R, Marynissen G. High prevalence of foot diseases in Europe: results of the Achilles Project. Mycoses. 2003 Dec;46(11-12):496-505. doi: 10.1046/j.0933-7407.2003.00933.x.
PubMed 14641624Lopez-Lopez D, Perez-Rios M, Ruano-Ravina A, Losa-Iglesias ME, Becerro-de-Bengoa-Vallejo R, Romero-Morales C, Calvo-Lobo C, Navarro-Flores E. Impact of quality of life related to foot problems: a case-control study. Sci Rep. 2021 Jul 15;11(1):14515. doi: 10.1038/s41598-021-93902-5.
PubMed 34267276Valensi P, Girod I, Baron F, Moreau-Defarges T, Guillon P. Quality of life and clinical correlates in patients with diabetic foot ulcers. Diabetes Metab. 2005 Jun;31(3 Pt 1):263-71. doi: 10.1016/s1262-3636(07)70193-3.
PubMed 16142017Bennett PJ, Patterson C, Wearing S, Baglioni T. Development and validation of a questionnaire designed to measure foot-health status. J Am Podiatr Med Assoc. 1998 Sep;88(9):419-28. doi: 10.7547/87507315-88-9-419.
PubMed 9770933
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Validation of the Foot Health Status Questionnaire in French Language
- ClinicalTrials.gov ID
- NCT06933953
- Acronym / sponsor ID
- FHSQ-Fr / CHUO-2024-12
- Conditions
- Patients With Foot Problems
- Keywords
- Surveys and Questionnaires, FHSQ French translation, Health status, Foot, Validity, Reliability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 18 Apr 2025 (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.
A French foot health survey showed that 73% of people examined felt pain and 38% don't left their home, which suggest a reduction in their life's quality and autonomy. Developed by Paul Bennett, FHSQ is a foot health-specific self administrated questionnaire. It sensitively detects changes in patients' foot health status, whatever their pathology, across multidimensional concepts of their quality of life. Actually, more than 150 scientific publications have cited it. Reliable and valid, it has already been translated and validated in multiple languages, but not in French. The subject of this study is to validate the translated and cross-cultural adapted French version FHSQ-fr through its psychometric results of validity and reliability. The study follows a 2-stage methodology.
The first, already completed, consisted of (back)translating the Australian FHSQ questionnaire into French by a scientific committee in order to obtain a pre-final version.
The second is to validate this final version using appropriate statistical analysis, including correlations studies with other French validated questionnaires, to determine its psychometric characteristics.
Detailed description
To assess validity, 150 volunteers will fill out French validated questionnaires, Foot Function Index (FFI), EuroQuality of life 5D-5L (EQ5D) , Visual Analogic Pain Scale (VAPS), and Short Form 12 Health survey (SF12). They will be evaluated about their pain, morphology, function and posture of their feet as usual at a podiatric school. To assess reliability, 50 respondents from the 150 who didn't receive any treatment after 7 to 10 days, will complete the FHSQ-fr again. It would improve knowledge of the status of foot health and its related quality of life in the general population and those suffering from specific pathologies such as diabetes or rheumatoid arthritis, the effectiveness of certain treatments on the same foot condition, and their evolutions using longitudinal studies in France. At the international, the French future results of studies using this clinimetric tool could be compared with those who come from other countries, and integrated to the Australian author's " Bigdataset" which compares, analyses and predicts more accurately the clinically significant efficacy of a treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with foot problems | Other | Other: QuestionnairesPatients will complete many questionnaires : FHSQ-fr, Foot Function Index, EQ-5D-5L, Visual Analog Pain Scale, SF-12 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients coming to IFRES in Alençon (61) France for a pedicure or podiatry appointment,
- Age >= 18
- knowing how to speak, read and write French.
Key exclusion criteria (1 listed)
- 1. Have already taking part in this research before the proposition to get in.
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 |
|---|---|---|
| QuestionnairesPatients will complete various questionnaires at J0: FHSQ-Fr, EQ-5D-5L, Foot Function Index, Visual analog pain scale, SF-12. Patients who needs to come back for a visit at Day 7 (+ 3 days) will complete the FHSQ-Fr questionnaire for a second time | Other | Patients with foot problems |
Primary outcome
Internal consistency
Time frame: Day 0
It is evaluated using Cronbach's alpha coefficient "α", which measures the internal consistency of a set of items, scales or sub-scales for a single clinical dimension. The value of this index is less than or equal to 1, and the closer alpha is to 1, the stronger it is. α" > 0.7 or >0.8 is considered fairly high. However, the coefficient must not be too close to 1, otherwise the items are redundant and duplicate each other.
Temporal stability of patients' questionnaire scores FHSQ-en V 1.02
Time frame: Day 0 and day 7
It is measured by the Intraclass Correlation Coefficient (ICC) and its 95% confidence interval, and/or the Pearson Correlation Coefficient. By convention, fidelity is said to be: * Very good if ICC ≥0 91 * Good if 0.9 ≤ ICC ≤ 0.71 * Moderate if 0.70 ≤ ICC ≤ 0.51 * Poor if 0.5 ≤ ICC ≤ 0.31 * Very poor or nil if ICC ≤ 0.3
Measurement error
Time frame: Day 0
To apply the criterion of good measurement error, the MIC (Minimal Important Change), the SDC (Smallest Detectable Change) or the LoA (Limits of Agreement) load will be calculated using a longitudinal approach based on anchoring.
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 30 Apr 2026.
- Background: PubMed 14641624Burzykowski T, Molenberghs G, Abeck D, Haneke E, Hay R, Katsambas A, Roseeuw D, van de Kerkhof P, van Aelst R, Marynissen G. High prevalence of foot diseases in Europe: results of the Achilles Project. Mycoses. 2003 Dec;46(11-12):496-505. doi: 10.1046/j.0933-7407.2003.00933.x.
- Background: PubMed 34267276Lopez-Lopez D, Perez-Rios M, Ruano-Ravina A, Losa-Iglesias ME, Becerro-de-Bengoa-Vallejo R, Romero-Morales C, Calvo-Lobo C, Navarro-Flores E. Impact of quality of life related to foot problems: a case-control study. Sci Rep. 2021 Jul 15;11(1):14515. doi: 10.1038/s41598-021-93902-5.
- Background: PubMed 16142017Valensi P, Girod I, Baron F, Moreau-Defarges T, Guillon P. Quality of life and clinical correlates in patients with diabetic foot ulcers. Diabetes Metab. 2005 Jun;31(3 Pt 1):263-71. doi: 10.1016/s1262-3636(07)70193-3.
- Background: PubMed 9770933Bennett PJ, Patterson C, Wearing S, Baglioni T. Development and validation of a questionnaire designed to measure foot-health status. J Am Podiatr Med Assoc. 1998 Sep;88(9):419-28. doi: 10.7547/87507315-88-9-419.
- A few figures on foot health in France - UFSPLink provided by the sponsor.
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.
Delphine GUYET principal investigator
IFRES of Alençon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires in people with Patients With Foot Problems, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
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 1 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 30 Apr 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 France. 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 Stéphanie MARDHEL (0788586556 ext. +33, stephanie.mardhel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal consistency (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06933953, which also lists 4 linked publications.
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 30 Apr 2026.