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Recruiting
NCT04063592
AMI Construction in Lower Extremity Residual Limbs
Conditions: Amputation
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 26
Sponsor: Brigham and Women's Hospital
Location: Walter Reed National Military Medical Center Bethesda Maryland
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
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT04063592). StuddyBuddy aggregates publicly available trial information.