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:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT03550118
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* Unilateral transtibial amputee
* At least 6 months post-amputation
* Wear prosthesis at least 3 hours per day
* Use an elastomeric (i.e. gel) liner
* K3 or higher Medicare Functional Classification Level
* Able to walk continuously with prosthesis for at least 5 minutes at a time, sit, stand, and step up a height of 5.0 cm.
* Residual limb of 9.0 cm or longer
* Experience problems with volume fluctuations that affect their prosthetic socket fit
Exclusion Criteria:
* Participants experiencing skin breakdown on enrollment will be excluded, but can enter after having been free of clinically visually-apparent skin breakdown for two weeks.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03550118
Study Brief:
Protocol Section:
NCT03550118