Status:
RECRUITING
AMI Construction in Lower Extremity Residual Limbs
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Massachusetts Institute of Technology
Walter Reed National Military Medical Center
Conditions:
Amputation
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 an...
Detailed Description
The hypothesis of this research protocol is that we will be able to modify the residual limbs of patients who have already undergone lower extremity amputations so as to include biological actuators t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04063592
Start Date
February 24 2020
End Date
September 30 2026
Last Update
October 17 2025
Active Locations (3)
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1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
3
Massachusetts Institute of Technology
Cambridge, Massachusetts, United States, 02139