Recruiting NA Amputation

New treatment option for Amputation

Official title Impact of Improving Footwear Options

ClinicalTrials.gov ID: NCT05601869

What this study is testing

What it's testing
Veterans with leg amputations have limited footwear options because their artificial feet do not change shapes for different shoes. Studies have shown that women with amputations receive more frequent prosthetics care than men, but are less satisfied with the fit, comfort, and appearance of their prostheses.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 89

You may be able to join if

  • US military Veterans that identify as women
  • Transtibial (below-knee) amputation
  • Using a definitive prosthesis for at least 6 months (limb has accommodated to prosthesis use post-amputation)
  • Well fitting and well aligned prosthesis
  • Blessed Orientation-Memory-Concentration (Short Blessed) score between 0-6

You likely can't join if

  • Residual limb skin problems
  • Residual limb too long to accommodate the RECOVER prosthetic ankle-feet system
  • Unable or unwilling to travel to Minneapolis
  • Not a regular prosthesis user
  • Mass over 125 kg
  • Documented neurocognitive disorder (e.g., dementia) with evidence of impact on activities of daily living and/or instrumental activities of daily...
See the full eligibility criteria
Who can join
  • US military Veterans that identify as women
  • Transtibial (below-knee) amputation
  • Using a definitive prosthesis for at least 6 months (limb has accommodated to prosthesis use post-amputation)
  • Well fitting and well aligned prosthesis
  • Blessed Orientation-Memory-Concentration (Short Blessed) score between 0-6
  • Access to computer, tablet, or smart phone and internet for video conferencing and RedCap data collection
What rules you out
  • Residual limb skin problems
  • Residual limb too long to accommodate the RECOVER prosthetic ankle-feet system
  • Unable or unwilling to travel to Minneapolis
  • Not a regular prosthesis user
  • Mass over 125 kg
  • Documented neurocognitive disorder (e.g., dementia) with evidence of impact on activities of daily living and/or instrumental activities of daily living
  • Baseline ABIS-R or PROMIS-APSRA scores at the maximum levels (no room for improvement on primary outcomes)

The study team makes the final eligibility decision.

Where it's taking place

  • Minneapolis, Minnesota, 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 to 89 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Minneapolis, Minnesota, 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.