Limb Revision Surgery for Amputation

Recruiting at 2 trial locations

Overseen By Research Coordinators

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Cardiopulmonary issues, Peripheral neuropathies, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

26 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Matthew J Carty, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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.

Inclusion Criteria

I experience discomfort from my amputation stump.

You are able to communicate effectively.

I experience severe, unmanageable pain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Intervention

Subjects undergo the proposed operative intervention to modify residual limbs and include biological actuators

1 week

1 visit (in-person)

Postoperative Rehabilitation

Development of a modified acute postoperative rehabilitation strategy suited to the new surgical approach

4-8 weeks

Follow-up

Participants are monitored for safety, effectiveness, and various outcome measures including general health, limb morphology, motor activation, proprioception, and sensory perception

Years 1-3

Treatment Details

Interventions

• Residual limb revision

Trial Overview 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).

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Subjects undergoing the proposed operative intervention. Intervention patients will serve as their own control for all outcome measures

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Massachusetts Institute of Technology

Collaborator

Trials

104

Recruited

12,810,000+

Walter Reed National Military Medical Center

Collaborator

Trials

149

Recruited

33,800+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+