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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05594446
• Other study ID #: 2022-A01136-37
• Status: Completed
• Start date: September 9, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2023
• Source: Sigvaris France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
France	Rastel Didier	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
Sigvaris France	Clin-Experts

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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