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Completed

NCT Number: NCT05594446

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

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

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rastel Didier

Grenoble, 38000, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Sigvaris France

Industry

Collaborators

  • Clin-Experts

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 26, 2022
Registry last updated
Apr 11, 2023

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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