Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534073
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Baropodometric Patterns Associated With Metatarsalgia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Identification of Baropodometric Patterns Associated With Metatarsalgia and Custom Design of Its Three-dimensional Element of Discharge to Integrate it in Stockings or Socks
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMEDESCAL
Brief Summary:
The therapeutic plan for certain pathologies in the adult population typically includes the performance of moderate physical activity aimed at preventing cardiovascular risk due to sedentary lifestyle improving muscle tone and balance to prevent falls enhancing bone health and maintaining proper functional and mental health state However this activity can be hindered by pain arising from musculoskeletal injuries of low or moderate significance One such injury is metatarsalgia characterized by acute or chronic pain in the plantar area of the forefoot due to an overload of plantar pressure It affects one or several central metatarsals and their respective metatarsophalangeal joints Metatarsalgia is a highly prevalent pathology up to 83 in patients aged 60 or older and negatively impacts their quality of life To alleviate plantar pressure in the affected area metatarsal offloading devices are commonly used which can now be integrated into socks or stockings This integration aids in pain reduction through an everyday easy-to-use item However only preliminary results of their effectiveness exist and are in a standard model without customization for the patients foot Therefore the goal is to identify different plantar pressure patterns in a sample of female patients over 55 years with metatarsalgia and design personalized three-dimensional plantar elements that can be integrated into the socks structure to reduce over pressure and improve the clinical picture A prior evaluation of pain Foot Pain and Disability Index impact on quality of life SF-12 questionnaire assessment of physical activity IPAQ and baropodometric evaluation with instrumented Pedar insoles Novel Germany will be conducted This will characterize the patterns of plantar pain Using 3D scanning of the foot a personalized three-dimensional element for each plantar pain pattern will be designed to relieve this excess load and will be integrated into the body of the sock through weaving thermofusion or thermosealing This sample of patients with metatarsalgia will be randomly divided into three groups who for a period of six months will wear the offloading sock model personalized plantar supports with selective offloading or a stabilizing element for the affected metatarsal head that the patient can apply and remove themselves After these six months plantar pain quality of life and physical activity levels will be re-evaluated in the three groups to determine the potential efficacy of the experimental sock compared to the best possible treatment insoles and another common element such as alignment devices The offloading sock would provide a personalized solution for each patient requiring no adaptation or frequent replacement thus creating better adherence to treatment The number of effective treatment usage hours would increase since socks are part of the patients regular attire Additionally associated costs would be reduced as there would be no need for frequent replacement of removable pads stabilizing devices or regular revisions to adjust orthopedic insoles
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None