DiabetesNCT05594446
Morphometric Study of the Legs and Feet of Diabetic Patients in Order to Collect Data Intended to be Used to Measure by Dynamometry the Pressures Exerted by Several Medical Compression Socks at the Level of the Forefoot
An observational study of Diabetes, run by Sigvaris France at 1 site in France.
Trial summary
The aim of the study is to collect morphometric data of legs and feet in diabetic patients in order to model in the laboratory the pressures exerted by compression stockings on different areas of the foot Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- How many people
- 89 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2022to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: The recruitment of participants will be done within the framework of the usual consultation of the participating doctor, among the population meeting the inclusion criteria.
Who may be able to join
- Patients of both sexes over the age of 18
- Patients with diabetes of any type, balanced or not, with or without a history of mal perforating
- Giving their oral agreement to participate after information
Who cannot join
- Patients seen in an emergency
- Patient with lower limb amputee (even partial)
- Patients with a foot wound, whatever the etiology of the wound
- Presence of lymphedema
- History of foot trauma with sequelae
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to collect morphometric data of legs and feet in diabetic patients in order to model in the laboratory the pressures exerted by compression stockings on different areas of the foot
- Conditions
- Diabetes
- Keywords
- diabetes, compression stockings
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of anthropometric measurements of the foot : Ankle circumference at thinnest point (cm)
From the anthropometric data collected, measurements will be made on specific areas by a dynamometric method in the textile laboratory, in particular pressure measurements by different medical compression stockings. These pressure measurements will be estimates of the pressures exerted on areas at risk of the feet of diabetic patients by different medical compression stockings
Measured: 3 minutes
Collection of anthropometric measurements of the foot : Popliteal heel height (cm)
From the anthropometric data collected, measurements will be made on specific areas by a dynamometric method in the textile laboratory, in particular pressure measurements by different medical compression stockings. These pressure measurements will be estimates of the pressures exerted on areas at risk of the feet of diabetic patients by different medical compression stockings
Measured: 3 minutes
Collection of anthropometric measurements of the foot : Circumference of the calf at the strongest point (cm)
From the anthropometric data collected, measurements will be made on specific areas by a dynamometric method in the textile laboratory, in particular pressure measurements by different medical compression stockings. These pressure measurements will be estimates of the pressures exerted on areas at risk of the feet of diabetic patients by different medical compression stockings
Measured: 3 minutes
Collection of anthropometric measurements of the foot : Circumference of the forefoot at the level of the metatarsal heads (cm)
From the anthropometric data collected, measurements will be made on specific areas by a dynamometric method in the textile laboratory, in particular pressure measurements by different medical compression stockings. These pressure measurements will be estimates of the pressures exerted on areas at risk of the feet of diabetic patients by different medical compression stockings
Measured: 3 minutes
Collection of anthropometric measurements of the foot : Radius of curvature estimated by a template, of the head of the first metatarsus (cm)
From the anthropometric data collected, measurements will be made on specific areas by a dynamometric method in the textile laboratory, in particular pressure measurements by different medical compression stockings. These pressure measurements will be estimates of the pressures exerted on areas at risk of the feet of diabetic patients by different medical compression stockings
Measured: 3 minutes
Collection of anthropometric measurements of the foot : Radius of curvature estimated by a template, of the head of the last metatarsus (cm)
From the anthropometric data collected, measurements will be made on specific areas by a dynamometric method in the textile laboratory, in particular pressure measurements by different medical compression stockings. These pressure measurements will be estimates of the pressures exerted on areas at risk of the feet of diabetic patients by different medical compression stockings
Measured: 3 minutes
Collection of anthropometric measurements of the foot : European shoe size
From the anthropometric data collected, measurements will be made on specific areas by a dynamometric method in the textile laboratory, in particular pressure measurements by different medical compression stockings. These pressure measurements will be estimates of the pressures exerted on areas at risk of the feet of diabetic patients by different medical compression stockings
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start9 Sep 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sigvaris France
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clin-Experts
- Responsible party
- Sponsor
- Investigators
- Didier RASTEL, PhD, Principal investigator, SELARL PHILANGIO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594446
- Sponsor's protocol ID
- 2022-A01136-37
- Status last verified
- Apr 2023
- First submitted
- 16 Oct 2022
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphometric Study of the Legs and Feet of Diabetic Patients in Order to Collect Data Intended to be Used to Measure by Dynamometry the Pressures Exerted by Several Medical Compression Socks at the Level of the Forefoot
- ClinicalTrials.gov ID
- NCT05594446
- Acronym / sponsor ID
- 2022-A01136-37
- Conditions
- Diabetes
- Keywords
- diabetes, compression stockings
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Sigvaris FranceIndustry (pharma, biotech, devices)
- Collaborators
- Clin-Experts
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 26 Oct 2022 (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 aim of the study is to collect morphometric data of legs and feet in diabetic patients in order to model in the laboratory the pressures exerted by compression stockings on different areas of the foot
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The recruitment of participants will be done within the framework of the usual consultation of the participating doctor, among the population meeting the inclusion criteria.
Key inclusion criteria (3 listed)
- Patients of both sexes over the age of 18
- Patients with diabetes of any type, balanced or not, with or without a history of mal perforating
- Giving their oral agreement to participate after information
Key exclusion criteria (5 listed)
- Patients seen in an emergency
- Patient with lower limb amputee (even partial)
- Patients with a foot wound, whatever the etiology of the wound
- Presence of lymphedema
- History of foot trauma with sequelae
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collection of anthropometric measurements of the foot : Ankle circumference at thinnest point (cm)
Time frame: 3 minutes
From the anthropometric data collected, measurements will be made on specific areas by a dynamometric method in the textile laboratory, in particular pressure measurements by different medical compression stockings. These pressure measurements will be estimates of the pressures exerted on areas at risk of the feet of diabetic patients by different medical compression stockings
Collection of anthropometric measurements of the foot : Popliteal heel height (cm)
Time frame: 3 minutes
From the anthropometric data collected, measurements will be made on specific areas by a dynamometric method in the textile laboratory, in particular pressure measurements by different medical compression stockings. These pressure measurements will be estimates of the pressures exerted on areas at risk of the feet of diabetic patients by different medical compression stockings
Collection of anthropometric measurements of the foot : Circumference of the calf at the strongest point (cm)
Time frame: 3 minutes
From the anthropometric data collected, measurements will be made on specific areas by a dynamometric method in the textile laboratory, in particular pressure measurements by different medical compression stockings. These pressure measurements will be estimates of the pressures exerted on areas at risk of the feet of diabetic patients by different medical compression stockings
Collection of anthropometric measurements of the foot : Circumference of the forefoot at the level of the metatarsal heads (cm)
Time frame: 3 minutes
From the anthropometric data collected, measurements will be made on specific areas by a dynamometric method in the textile laboratory, in particular pressure measurements by different medical compression stockings. These pressure measurements will be estimates of the pressures exerted on areas at risk of the feet of diabetic patients by different medical compression stockings
Collection of anthropometric measurements of the foot : Radius of curvature estimated by a template, of the head of the first metatarsus (cm)
Time frame: 3 minutes
From the anthropometric data collected, measurements will be made on specific areas by a dynamometric method in the textile laboratory, in particular pressure measurements by different medical compression stockings. These pressure measurements will be estimates of the pressures exerted on areas at risk of the feet of diabetic patients by different medical compression stockings
Collection of anthropometric measurements of the foot : Radius of curvature estimated by a template, of the head of the last metatarsus (cm)
Time frame: 3 minutes
From the anthropometric data collected, measurements will be made on specific areas by a dynamometric method in the textile laboratory, in particular pressure measurements by different medical compression stockings. These pressure measurements will be estimates of the pressures exerted on areas at risk of the feet of diabetic patients by different medical compression stockings
Collection of anthropometric measurements of the foot : European shoe size
Time frame: 3 minutes
From the anthropometric data collected, measurements will be made on specific areas by a dynamometric method in the textile laboratory, in particular pressure measurements by different medical compression stockings. These pressure measurements will be estimates of the pressures exerted on areas at risk of the feet of diabetic patients by different medical compression stockings
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Didier RASTEL, PhD principal investigator
SELARL PHILANGIO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Sigvaris France 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 5 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: finished, as of the sponsor's last update on 11 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of anthropometric measurements of the foot : Ankle circumference at thinnest point (cm) (time frame: 3 minutes). The study lists 7 primary outcomes in all. 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 11 Apr 2023.