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Prosthetic Device

NU-FlexSIS Prosthetic Socket for Leg Amputation

N/A

Recruiting

Led By Stefania Fatone, PhD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up all participants: baseline period weeks 0, 4, 8, 12; intervention group: intervention period weeks 0, 4, 8, 12, 16, 20, 24; reference group: monitoring period weeks 4, 12, 20, 24.

Awards & highlights

Study Summary

This trial tests if a new prosthetic socket design improves comfort, wear time, mobility, participation, quality of life, and satisfaction for people with transfemoral amputations.

Who is the study for?

This trial is for adults over 18 with a below-knee amputation who have been using a prosthesis for at least a year. They should be able to perform limited community walking, use their upper limbs, and manage technology like computers or smartphones. Veterans are specifically included at VA sites. Participants must not plan to change their prosthetic knee or foot soon and cannot have certain health conditions like active cancer.Check my eligibility

What is being tested?

The study is testing the NU-FlexSIS, which is a new type of socket for leg prostheses designed to improve comfort and mobility compared to the standard socket used after thigh-level leg amputations. The goal is to see if this new design enhances quality of life, increases how long the prosthesis can be worn daily, and improves overall satisfaction.See study design

What are the potential side effects?

While specific side effects aren't listed for trying out a new prosthetic socket design like NU-FlexSIS, participants might experience discomfort or skin issues where the prosthesis attaches due to differences in fit or pressure distribution.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ all participants: baseline period weeks 0, 4, 8, 12; intervention group: intervention period weeks 0, 4, 8, 12, 16, 20, 24; reference group: monitoring period weeks 4, 12, 20, 24.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~all participants: baseline period weeks 0, 4, 8, 12; intervention group: intervention period weeks 0, 4, 8, 12, 16, 20, 24; reference group: monitoring period weeks 4, 12, 20, 24.

This trial's timeline: 3 weeks for screening, Varies for treatment, and all participants: baseline period weeks 0, 4, 8, 12; intervention group: intervention period weeks 0, 4, 8, 12, 16, 20, 24; reference group: monitoring period weeks 4, 12, 20, 24. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Socket Comfort Score (SCS)

Secondary outcome measures

Activities-specific Balance Confidence (ABC) Scale

Charlson Comorbidity Index (CCI)

Falls

+9 more

Other outcome measures

Amputee Mobility Predictor with Prosthesis (AMP-Pro)

International Society for Prosthetics and Orthotics (ISPO) Minimum Data Set for lower-limb prosthesis users involved Research Studies

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention

Participants will be assessed for 12 weeks in their usual ischial containment socket before receiving a subischial socket to be worn and assessed for 24 weeks.

Group II: Reference GroupActive Control1 Intervention

Participants will be assessed for 40 weeks in their usual ischial containment socket. No intervention will be provided.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Congressionally Directed Medical Research ProgramsFED

47 Previous Clinical Trials

6,463 Total Patients Enrolled

University of WashingtonLead Sponsor

1,741 Previous Clinical Trials

1,847,651 Total Patients Enrolled

Stefania Fatone, PhDPrincipal InvestigatorUniversity of Washington

2 Previous Clinical Trials

110 Total Patients Enrolled

Media Library

Northwestern University Flexible Subischial Suction Socket (NU-FlexSIS) (Prosthetic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05662982 — N/A

Frequently Asked Questions

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

Are the doors open to participants in this clinical trial?

"Clinicaltrials.gov notes that this particular medical trial, which was initially posted on the 1st of February 2023 and last modified on the 20th December 2022, is not currently seeking patients. Nevertheless, there are two alternative clinical trials recruiting at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sub-Ischial Socket for Transfemoral Amputation and Lower Mobility

Stefania Fatone 2023. "Sub-Ischial Socket for Transfemoral Amputation and Lower Mobility". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05662982.