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 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT03927404
Eligibility Criteria:
Inclusion Criteria:
* Ages of 18 and above
* Unilateral transtibial or transfemoral amputee
* Ambulate at a K2 level or higher
* At least 3 months post-amputation per physician discretion
* Residual limb length greater than 6.5 inches in length
* Able to follow directions and give informed consent on their own or through Legally Authorized Representative.
* Must be able to ambulate without assistance. An external assistance device such as cane or walker will be permitted.
* Adequate arterial blood flow as evidenced by a TcOM \>30mmHg measured within the past 12 months.
Exclusion Criteria:
* Conditions that prevent wearing a prosthetic socket,such as existing scab, ulcer, or keloid scar on amputation stump.
* Cognitive deficits or mental health problems that would limit ability to consent and participate fully in the study protocol
* Women who are pregnant or who plan to become pregnant in the near future
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03927404
Study Brief:
Protocol Section:
NCT03927404