NCT04063592 AMI Construction in Lower Extremity Residual Limbs
| NCT ID | NCT04063592 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brigham and Women's Hospital |
| Condition | Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 26 participants |
| Start Date | 2020-02-24 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 26 participants in total. It began in 2020-02-24 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Matthew J Carty, MD
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT04063592 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04063592 currently recruiting?
Yes, NCT04063592 is actively recruiting participants. Contact the research team at mcarty@partners.org for enrollment information.
Where is the NCT04063592 trial being conducted?
This trial is being conducted at Bethesda, United States, Boston, United States, Cambridge, United States.
Who is sponsoring the NCT04063592 clinical trial?
NCT04063592 is sponsored by Brigham and Women's Hospital. The principal investigator is Matthew J Carty, MD at Brigham and Women's Hospital. The trial plans to enroll 26 participants.