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New treatment option for Amputation, Lower Limb
Official title Quantifying Bone and Skin Movement in the Residual Limb of Individuals With Transtibial Amputation Using Dynamic Stereo X-Ray
ClinicalTrials.gov ID: NCT05287646
What this study is testing
- What it's testing
- Individuals with lower extremity amputation are often challenged by complications that arise from poor prosthetic fit, including movement of the residual limb in the socket, known as pistoning. Pistoning can lead to gait instability, skin problems, and pain.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Unilateral transtibial amputation (any etiology)
- At least 18 years old
- At least 6-months post-amputation
- Current prosthetic users (at least 6 hours/day)
You likely can't join if
- Unable to ambulate on a treadmill at low to moderate speed
- Inability to tolerate the socket suspensions
- Length of the residual limb prohibits socket fitting, dynamic stereo x-ray data capture, or marker placement
- Mental impairment that impedes study compliance
- Skin conditions (i.e. burns or poor skin coverage) as well as those with severe contractures that prevent prior prosthetic wear
- Severe neuropathy, uncontrolled diabetes, have insensate foot, severe phantom pain, or a significant history of skin ulcers
See the full eligibility criteria
- Unilateral transtibial amputation (any etiology)
- At least 18 years old
- At least 6-months post-amputation
- Current prosthetic users (at least 6 hours/day)
- Unable to ambulate on a treadmill at low to moderate speed
- Inability to tolerate the socket suspensions
- Length of the residual limb prohibits socket fitting, dynamic stereo x-ray data capture, or marker placement
- Mental impairment that impedes study compliance
- Skin conditions (i.e. burns or poor skin coverage) as well as those with severe contractures that prevent prior prosthetic wear
- Severe neuropathy, uncontrolled diabetes, have insensate foot, severe phantom pain, or a significant history of skin ulcers
- Any other significant comorbidity that would interfere with the study
- Severe circulatory problems including peripheral vascular disease and pitting edema
- Cognitive deficits or mental health problems that would limit ability to participate fully in the study protocol
- Women who are pregnant or who plan to become pregnant during the study
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.