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Clinical Trials/NCT05594446
NCT05594446
Completed
N/A

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

Sigvaris France1 site in 1 country89 target enrollmentSeptember 9, 2022
ConditionsDiabetes

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes
Sponsor
Sigvaris France
Enrollment
89
Locations
1
Primary Endpoint
Collection of anthropometric measurements of the foot : Radius of curvature estimated by a template, of the head of the first metatarsus (cm)
Status
Completed
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
September 9, 2022
End Date
March 31, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sigvaris France
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

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

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

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

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

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

Study Sites (1)

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