Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:22 PM
Ignite Modification Date:
2025-12-24 @ 4:22 PM
NCT ID:
NCT06597266
Eligibility Criteria:
Inclusion Criteria:
* aged 18 years or over
* Attend the Bristol, Oxford or Roehampton NHS Opcare prosthetic services
* Have had a transtibial amputation
* Deemed ready to cast for a new prosthesis by the clinical team as per usual care at the prosthetic centre
* Able to understand verbal and written English and provide informed consent
Exclusion Criteria:
* under the age of 18
* Have had an ankle disarticulation, Knee disarticulation or transfemoral amputation
* Contraindication to be fit for a prosthetic socket
* Unwilling to trial or unable to tolerate trialling two sockets at a fitting session
* Unable to answer verbal questions (as per normal fitting appointment) on their socket fitting and comfort
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06597266
Study Brief:
Protocol Section:
NCT06597266