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The trial is taking place at:
C

Centre Hospitalier Universitaire de Lille | Claude Huriez Hospital - Gastroenterology Department

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Assessment of the Safety and Performance of a Compression Ankle Support in the Prevention of Injuries During Sports Practice

D

Decathlon

Status

Enrolling

Conditions

Chronic Pain
Chronic Instability of Ankle Joint

Treatments

Device: ankleSOFT100

Study type

Interventional

Funder types

Industry

Identifiers

NCT04742088
ankleSOFT100

Details and patient eligibility

About

Decathlon has developed ankleSOFT100 product which is medical device designed to reduce pain and joint instability during sport practice. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon ankleSOFT100 product to demonstrate safety and performance of this device in a real-world setting.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Subject is aged ≥18 years old
  • Subject has chronic pain AND / OR chronic ankle instability
  • The current condition of his/her ankle allows the subject to pursue a usual physical activity
  • Subject has been informed and is willing to sign an informed consent form
  • Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (6 weeks)
  • Subject is affiliated to the French social security regime

Non-inclusion Criteria:

  • Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent
  • Subject has worn a support (ankle brace or articulated orthosis) during sports sessions during the last month
  • Subject has any medical condition that could impact the study at investigator's discretion
  • Subject has a known hypersensitivity or allergy to the components of the device (polyamide, elastodiene, elastane, polyester, synthetic rubber)
  • Adult subject to a legal protection measure

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Orthosis group
Experimental group
Treatment:
Device: ankleSOFT100

Trial contacts and locations

4

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Central trial contact

Jean HEE

Data sourced from clinicaltrials.gov

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