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 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT00117793
Eligibility Criteria:
Inclusion Criteria:
* Over 18 and less than 70 years of age,
* Have a below knee amputation involving only one side,
* If the cause of amputation was for traumatic reasons and do not have diabetes or a vascular condition, the amputation must have occurred at least six months ago and the potential subject must have worn a prosthesis for at least four months,
* If the cause of amputation was for diabetes or vascular reasons, the potential subject must have been fit with a prosthesis and have worn it for at least one year,
* Wear the prosthesis for at least 6 hours a day,
* Able to walk without a cane, crutches, or a walker,
* Are moderately active enough to walk at a steady pace for at least 30 minutes.
Exclusion Criteria:
* Have pain in legs or any condition that interferes with walking.
* Have an ulcer on the residual limb,
* If potential subject had an amputation because of a tumor or an infection, no longer have an active tumor or undergoing treatment for a tumor,
* Have fallen within the last 3 months.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00117793
Study Brief:
Protocol Section:
NCT00117793