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

Sponsor
Sigvaris France (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05594446
Collaborator
Clin-Experts (Industry)
90
1
6.6
13.6

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    90 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Sep 9, 2022
    Anticipated Primary Completion Date :
    Mar 30, 2023
    Anticipated Study Completion Date :
    Mar 30, 2023

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rastel Didier Grenoble France 38000

    Sponsors and Collaborators

    • Sigvaris France
    • Clin-Experts

    Investigators

    • Principal Investigator: Didier RASTEL, PhD, SELARL PHILANGIO

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sigvaris France
    ClinicalTrials.gov Identifier:
    NCT05594446
    Other Study ID Numbers:
    • 2022-A01136-37
    First Posted:
    Oct 26, 2022
    Last Update Posted:
    Oct 26, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sigvaris France

    Study Results

    No Results Posted as of Oct 26, 2022