NCT07263945 Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes
| NCT ID | NCT07263945 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Colorado, Denver |
| Condition | Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-11-25 |
| Primary Completion | 2030-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2025-11-25 with a primary completion date of 2030-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A clinical trial utilizing cross-over study design in which individuals with transtibial amputation using either a bone-anchored limb or standard socket prosthesis will perform activities of daily living with varying prosthetic foot stiffness categories to complete the following 4 Specific Aims: 1) Determine the influence of prosthetic foot stiffness on dynamic bone-implant loading, 2) Determine how prosthetic foot stiffness influences function, pain, and multi-joint biomechanics outcomes, 3) Establish how prosthetic foot stiffness influences osseoperception and fall risk, and 4) Establish target ranges of optimal foot stiffness based on the sensitivity biomechanical outcomes to variability in foot stiffness.
Eligibility Criteria
Inclusion Criteria: * Unilateral transtibial amputation due to traumatic, congenital, or cancer-related causes * \> 12-months bone-anchored limb implantation surgery (Bone Anchored Limb group) * \> 12-months limb amputation (Socket Control group) * Non-vascular amputation etiology * Low profile prosthetic foot (nominal) * Can walk unassisted for 5-minutes * \> 18 years old Exclusion Criteria: * Major amputation on contralateral limb * Vascular amputation etiology * Neurologic pathology that impairs coordination/balance * Regular assistive device use required for community ambulation * Inflammatory diseases or diabetes * Pregnancy or breastfeeding
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07263945 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07263945 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07263945 currently recruiting?
Yes, NCT07263945 is actively recruiting participants. Contact the research team at BRECCA.GAFFNEY@UCDENVER.EDU for enrollment information.
Where is the NCT07263945 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT07263945 clinical trial?
NCT07263945 is sponsored by University of Colorado, Denver. The trial plans to enroll 60 participants.