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

NCT05594446 | Completed

• 1 other identifier: 2022-A01136-37
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes

Keywords

diabetes; compression stockings

Outcome Measures

Primary Outcomes (7)

• 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

  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

  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

  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

  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

  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

  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

  3 minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sigvaris France: lead
• Clin-Experts: collaborator

Study Sites (1)

Rastel Didier

Grenoble, 38000, France

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Didier RASTEL, PhD

  SELARL PHILANGIO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: October 26, 2022
• Study Start: September 9, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)