BridgeMD
New treatment option for Amputation
Official title AMI Construction in Lower Extremity Residual Limbs
ClinicalTrials.gov ID: NCT04063592
What this study is testing
- What it's testing
- This study will involve the development of a novel approach to lower extremity residual limb surgical revision that offers the promise of augmenting volitional motor control, restore proprioception and reverse atrophy
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 65. Healthy volunteers may be eligible.
You may be able to join if
- Between the ages of 18-65
- Has already undergone a standard AKA or BKA procedure
- Suffers from symptoms such as:
- Intractable pain
- Deterioration of skin on or around stump
You likely can't join if
- Inadequate health to undergo operative procedure using standard anesthesia (i.e. cardiopulmonary)
- Individuals with impaired wound healing
- Individuals suffering from extensive peripheral neuropathies
- Active smokers
- Individuals with a history of poor compliance
- Women who are pregnant or plan to become pregnant before surgical intervention
See the full eligibility criteria
- Between the ages of 18-65
- Has already undergone a standard AKA or BKA procedure
- Suffers from symptoms such as:
- Intractable pain
- Deterioration of skin on or around stump
- Suffering from other sources of discomfort arising from stump
- Intact inherent wound healing
- Adequate communication skills
- High motivation
- Inadequate health to undergo operative procedure using standard anesthesia (i.e. cardiopulmonary)
- Individuals with impaired wound healing
- Individuals suffering from extensive peripheral neuropathies
- Active smokers
- Individuals with a history of poor compliance
- Women who are pregnant or plan to become pregnant before surgical intervention
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
- Boston, Massachusetts, United States
- Cambridge, Massachusetts, 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 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States; Boston, Massachusetts, United States; Cambridge, Massachusetts, 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.