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Prosthetic Limb Pump for Amputees (HIPPI Trial)

N/A

Recruiting

Led By Matthew J. Major, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Residual limb in good health

Ability to stand quietly and walk for 10 minutes continuously without an assistive device and without undue fatigue or health risks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediate

Awards & highlights

HIPPI Trial Summary

This trial will test a new design for a prosthetic limb pump. The pump creates a vacuum between the prosthetic socket and limb, which has benefits over other techniques including improved limb health and mobility.

Who is the study for?

This trial is for individuals who have had an amputation and are already using a prosthesis with vacuum-assisted suspension. Participants should be able to walk without assistance for at least 10 minutes, have good limb health, and have been using their current prosthesis for six months or more. Those with poor prosthetic fit, reduced limb sensation, or conditions affecting walking or balance cannot join.Check my eligibility

What is being tested?

The study is testing a new pump prototype designed to improve the suspension of prosthetic limbs by creating a vacuum between the socket and the limb. The goal is to enhance mobility and limb health. Participants will use this pump in laboratory settings while walking to assess its performance.See study design

What are the potential side effects?

Since this trial involves mechanical equipment rather than medication, traditional side effects are not expected. However, participants may experience discomfort due to adjustments in their prosthesis fit when using the new pump technology.

HIPPI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My amputated limb is healthy.

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I can stand and walk for 10 minutes without help or feeling overly tired.

Select...

I can walk with minimal assistance.

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I have used a vacuum-assisted prosthesis for at least 6 months.

HIPPI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediate

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediate

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediate for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Socket-reaction moments

Secondary outcome measures

Perceived mobility capability

Socket Comfort

HIPPI Trial Design

2Treatment groups

Experimental Treatment

Group I: UnlockedExperimental Treatment1 Intervention

The prototype mechanical system is free to compress normally

Group II: LockedExperimental Treatment1 Intervention

The prototype mechanical system is locked from compressing

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,610 Previous Clinical Trials

3,305,164 Total Patients Enrolled

Matthew J. Major, PhDPrincipal InvestigatorJesse Brown VA Medical Center, Chicago, IL

2 Previous Clinical Trials

43 Total Patients Enrolled

Media Library

Pump prototype (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04230512 — N/A

Amputation Research Study Groups: Unlocked, Locked

Amputation Clinical Trial 2023: Pump prototype Highlights & Side Effects. Trial Name: NCT04230512 — N/A

Pump prototype (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04230512 — N/A

Frequently Asked Questions

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

How much recruitment is taking place for this research project?

"Affirmative. Clinicaltrials.gov details that this clinical trial is presently seeking participants; it was initially posted on April 4th 2020 and the data was most recently updated on February 11th 2022. With a total of 20 patients being sought from 1 site, recruitment efforts are under way."

Answered by AI

Am I eligible to enroll in this clinical experiment?

"This medical trial is seeking to enrol 20 individuals aged 18-80 who have undergone amputation. To meet the criteria, candidates must possess a residual limb in excellent condition; demonstrate limited ambulation capabilities comparable with Medicare Functional Classification Level (K)2; be able to stand and walk unaided for at least 10 minutes without showing any signs of fatigue or health risks; and should have worn a definitive prosthesis that uses vacuum assisted suspension for no less than 6 months."

Answered by AI

Does this investigation allow for participants aged 18 and over?

"Participants must meet the age criteria to be considered eligible for inclusion: no younger than 18 and no older than 80."

Answered by AI

Are there any opportunities for individuals to volunteer as participants in this research?

"Affirmative. As per the info on clinicaltrials.gov, this research endeavour started accepting participants on April 4th 2020 and was most recently updated in February 11th 2022. The team is hoping to enrol 20 patients from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hybrid Pump Technology

2020. "Hybrid Pump Technology". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04230512.