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 @ 9:57 PM
Ignite Modification Date:
2025-12-24 @ 9:57 PM
NCT ID:
NCT02564432
Eligibility Criteria:
Inclusion Criteria:
1. Is a US military Veteran with transfemoral limb loss, that occurred at least 6 months prior to consent, and that the amputation is not a result of dysvascular disease.
2. Is at least 18 years of age or older.
3. Has previously used or is currently using a "socket suspension technology" prosthesis
4. Has, in the opinion of the investigator, normal cognitive function and no physical limitations, addictive diseases, or underlying medical conditions including tobacco use (continued testing for tobacco use will be performed at screening) that may prevent the subject from being an appropriate study candidate.
5. Is willing, able, and committed to participation in baseline and follow-up evaluations for the entire duration of the study.
6. Can provide written informed consent to participate.
Exclusion Criteria:
1. Is currently on active or reserve military duty
2. Has experienced systemic bacterial infection or localized infection at the stump site within the previous 6 months
3. Has had more than 1 limb amputated
4. Has a body mass index (BMI) 30
5. Has insulin dependent diabetes mellitus (IDDM) or has adult onset DM with a glycated hemoglobin (HbA1c) \> 53 mmol/mol (7.0%) at screening
6. Has residual femur bone length of less than 25% of the length of the contralateral femur.
7. Has clinically diagnosed vascular compromise proximal to the surgical site
8. Is pregnant at the time of surgery or plans to become pregnant within the first year of follow-up
9. Has evidence of recent tobacco use (urine cotinine test \> 300 ng/mL \[1703 nmol/L\]) and is not committed to a smoking-cessation program
10. Has renal insufficiency (defined as serum creatinine of 1.8 mg/dL) or is currently receiving renal dialysis
11. Is currently involved in or plans to be involved in high levels of physical activity (competitive sports, heavy physical labor, etc) during the first 12 months of the rehabilitation stage
12. Has muscular, neurologic or vascular deficiencies that may compromise the bone or soft tissue healing of the affected extremity
13. Has anemia characterized by a hemoglobin of 11 g/dL at the time of surgery
14. Is currently on oral anticoagulation (excluding low-dose aspirin for cardiac prophylaxis)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02564432
Study Brief:
Protocol Section:
NCT02564432