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

Completed

• Conditions: Diabetes

• Registration Number: NCT05594446
• Lead Sponsor: Sigvaris France

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-09
• Study First Submitted: 2022-10-16
• Study First Submitted QC: 2022-10-24
• Study First Posted: 2022-10-26
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-09
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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
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
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
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
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
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

Trial Locations

Locations (1)

Rastel Didier; 🇫🇷 Grenoble, France