RecruitingNot Applicable

AMI Construction in Lower Extremity Residual Limbs

United States26 participantsStarted 2020-02-24

Plain-language summary

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

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Limb Morphology and Changes in Muscle Volume

Timeframe: Years 1-3

Degree of Motor Activation of AMI Muscles and Volitional Control of Phantom Limb

Timeframe: Years 1-3

Evidence of Proprioception

Timeframe: Years 1-3

Evidence of Sensory Perception

Timeframe: Years 1-3

General Health

Timeframe: Years 1-3

Complications

Timeframe: Years 1-3

Trial details

NCT IDNCT04063592

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Matthew J Carty, MD

6179834555 mcarty@partners.org

View on ClinicalTrials.gov More Amputation trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Limb Morphology and Changes in Muscle Volume

Timeframe: Years 1-3

Degree of Motor Activation of AMI Muscles and Volitional Control of Phantom Limb

Timeframe: Years 1-3

Evidence of Proprioception

Timeframe: Years 1-3

Evidence of Sensory Perception

Timeframe: Years 1-3

General Health

Timeframe: Years 1-3

Complications

Timeframe: Years 1-3