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Prosthetic Socket

Caregiver-Assisted Limb Scanning for Amputees

N/A
Recruiting
Led By Glenn K Klute, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after a two week acclimation period where the participant wears the study prosthesis in the home, community, and work environments.
Awards & highlights
No Placebo-Only Group

Summary

This trial seeks to determine if digital tech & an untrained helper can capture shape of residual limb & create prosthetic socket that fits as well as one made by a prosthetist. If successful, this will reduce travel burden of rural Veterans & provide evidence to support use of digital tech in clinical practice.

Who is the study for?
This trial is for Veterans with a below-knee amputation who've used a prosthesis for at least 6 months, wear it over 4 hours daily, and can walk on a treadmill. They must be one-year post-amputation and have someone to help them with the study.
What is being tested?
The study compares two ways of making prosthetic sockets: one using digital technology by an untrained helper, and the other by a professional prosthetist using traditional methods. The fit and comfort reported by patients as well as pressure measurements will determine if the new method is effective.
What are the potential side effects?
There may not be direct side effects from participating in this trial; however, potential issues could arise from wearing ill-fitting prosthetics such as discomfort or skin problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after a two week acclimation period where the participant wears the study prosthesis in the home, community, and work environments.
This trial's timeline: 3 weeks for screening, Varies for treatment, and after a two week acclimation period where the participant wears the study prosthesis in the home, community, and work environments. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Comprehensive Lower-limb Amputee Socket Survey (CLASS) Comfort Score
Comprehensive Lower-limb Amputee Socket Survey (CLASS) Stability Score
Comprehensive Lower-limb Amputee Socket Survey (CLASS) Suspension Score
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Prosthetist socketExperimental Treatment1 Intervention
Participants will wear a prosthetic socket whose shape was captured by a prosthetist using traditional, hand casting methods.
Group II: Caregiver socketExperimental Treatment1 Intervention
Participants will wear a prosthetic socket whose shape was captured by a study helper using digital methods (i.e., a 3D scanner).

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,668 Previous Clinical Trials
3,765,841 Total Patients Enrolled
2 Trials studying Lower Extremity Amputation
26 Patients Enrolled for Lower Extremity Amputation
Glenn K Klute, PhDPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA
4 Previous Clinical Trials
60 Total Patients Enrolled
2 Trials studying Lower Extremity Amputation
36 Patients Enrolled for Lower Extremity Amputation

Media Library

Caregiver socket (Prosthetic Socket) Clinical Trial Eligibility Overview. Trial Name: NCT05884203 — N/A
Lower Extremity Amputation Research Study Groups: Caregiver socket, Prosthetist socket
Lower Extremity Amputation Clinical Trial 2023: Caregiver socket Highlights & Side Effects. Trial Name: NCT05884203 — N/A
Caregiver socket (Prosthetic Socket) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05884203 — N/A
~11 spots leftby Apr 2026
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