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

April 9, 2023 updated by: Sigvaris France
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

89

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • Rastel Didier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 minutes
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 minutes
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
3 minutes
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
3 minutes
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
3 minutes
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
3 minutes
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
3 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sigvaris France

Collaborators

Clin-Experts

Investigators

  • Principal Investigator: Didier RASTEL, PhD, SELARL PHILANGIO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2022

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

October 16, 2022

First Submitted That Met QC Criteria

October 24, 2022

First Posted (Actual)

October 26, 2022

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

April 9, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-A01136-37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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