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 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT07067203
Eligibility Criteria:
Inclusion Criteria:
1. All participants age 50 years or older, with the reason for amputation either peripheral vascular disease or diabetic complications (Nadollek \& Brauer, 2002).
2. Unilateral transtibial amputation only (Wood, 2022).
3. K-level (2 to 4) (Gailey et al., 2002).
4. Normal Body mass index ranged from 18.5 to 30.0 (Nuttall, 2015).
Exclusion Criteria:
1. Residual limb revision in the past six months (Wood, 2022).
2. Open wounds or sores on the residual limb limiting the ability to don/doff prosthesis (Wood, 2022).
3. Uncontrolled comorbidities such as cardiovascular disease, active cancer treatment, and uncontrolled Diabetes Mellitus (Wood, 2022).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT07067203
Study Brief:
Protocol Section:
NCT07067203