CompletedNot Applicable

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

France89 participantsStarted 2022-09-09

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Collection of anthropometric measurements of the foot : Ankle circumference at thinnest point (cm)

Timeframe: 3 minutes

Collection of anthropometric measurements of the foot : Popliteal heel height (cm)

Timeframe: 3 minutes

Collection of anthropometric measurements of the foot : Circumference of the calf at the strongest point (cm)

Timeframe: 3 minutes

Collection of anthropometric measurements of the foot : Circumference of the forefoot at the level of the metatarsal heads (cm)

Timeframe: 3 minutes

Collection of anthropometric measurements of the foot : Radius of curvature estimated by a template, of the head of the first metatarsus (cm)

Timeframe: 3 minutes

Collection of anthropometric measurements of the foot : Radius of curvature estimated by a template, of the head of the last metatarsus (cm)

Timeframe: 3 minutes

Trial details

NCT IDNCT05594446

SponsorSigvaris France

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-03-31

View on ClinicalTrials.gov More Diabetes trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Collection of anthropometric measurements of the foot : Ankle circumference at thinnest point (cm)

Timeframe: 3 minutes

Collection of anthropometric measurements of the foot : Popliteal heel height (cm)

Timeframe: 3 minutes

Collection of anthropometric measurements of the foot : Circumference of the calf at the strongest point (cm)

Timeframe: 3 minutes

Collection of anthropometric measurements of the foot : Circumference of the forefoot at the level of the metatarsal heads (cm)

Timeframe: 3 minutes

Collection of anthropometric measurements of the foot : Radius of curvature estimated by a template, of the head of the first metatarsus (cm)

Timeframe: 3 minutes

Collection of anthropometric measurements of the foot : Radius of curvature estimated by a template, of the head of the last metatarsus (cm)

Timeframe: 3 minutes