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Residual limb revision for Amputation

N/A
Recruiting
Led By Matthew J Carty, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Suffering from other sources of discomfort arising from stump
Intractable pain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up years 1-3
Awards & highlights

Study Summary

This trial will test a new method for surgical revision of residual limbs that could improve motor control, proprioception, and reverse atrophy.

Who is the study for?
This trial is for adults aged 18-65 who have had a below-knee (BKA) or above-knee (AKA) amputation and are experiencing intractable pain, discomfort from the stump, or skin deterioration around it. Participants should be highly motivated, able to communicate effectively, and possess natural wound healing abilities.Check my eligibility
What is being tested?
The study is testing a new surgical technique for revising lower extremity residual limbs. The goal is to improve voluntary muscle control, restore sensation of limb position and movement (proprioception), and reverse muscle wasting (atrophy).See study design
What are the potential side effects?
Potential side effects may include typical surgical risks such as infection, bleeding, pain at the surgery site, swelling, delayed wound healing, and possible adverse reactions to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I experience discomfort from my amputation stump.
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I experience severe, unmanageable pain.
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My skin is deteriorating around my amputation site.
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I have had an above-knee or below-knee amputation.
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I am between 18 and 65 years old.
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My body can heal wounds normally.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~years 1-3
This trial's timeline: 3 weeks for screening, Varies for treatment, and years 1-3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complications
Degree of Motor Activation of AMI Muscles and Volitional Control of Phantom Limb
Evidence of Proprioception
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Subjects undergoing the proposed operative intervention. Intervention patients will serve as their own control for all outcome measures

Find a Location

Who is running the clinical trial?

Massachusetts Institute of TechnologyOTHER
97 Previous Clinical Trials
12,729,961 Total Patients Enrolled
Walter Reed National Military Medical CenterFED
137 Previous Clinical Trials
34,462 Total Patients Enrolled
United States Department of DefenseFED
864 Previous Clinical Trials
327,573 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Massachusetts
How old are they?
18 - 65
What site did they apply to?
Brigham and Women's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
AMI Construction in Lower Extremity Residual Limbs
Matthew Carty 2020. "AMI Construction in Lower Extremity Residual Limbs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04063592.
~2 spots leftby Sep 2024
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