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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ after a two week acclimation period where the participant wears the study prosthesis in the home, community, and work environments.
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreTrial 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).
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,259 Total Patients Enrolled
2 Trials studying Lower Extremity Amputation
30 Patients Enrolled for Lower Extremity Amputation
Glenn K Klute, PhDPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA
4 Previous Clinical Trials
64 Total Patients Enrolled
2 Trials studying Lower Extremity Amputation
40 Patients Enrolled for Lower Extremity Amputation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have skin issues on my amputated limb.It has been over a year since my amputation.My current prosthesis does not fit well and cannot be adjusted.I have joint pain or an injury that affects my ability to walk.I understand and can communicate about the trial.I have been using a prosthesis for at least 6 months.I wear my prosthesis for 4 or more hours daily.My prosthesis attaches directly to the socket.I can walk on a treadmill.I have had one leg amputated below the knee.
Research Study Groups:
This trial has the following groups:- Group 1: Caregiver socket
- Group 2: Prosthetist socket
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age restriction for this research experiment limited to those under 20 years old?
"The inclusion criteria for this trial dictate that participants must be at least 18 years old and no more than 70."
Answered by AI
Are there currently any vacancies for prospective participants in this clinical trial?
"Data found on clinicaltrials.gov suggests that this medical study is not enrolling patients at present, with the initial posting being made on July 1st 2023 and an update occurring as recently as May 22nd 2023. Nevertheless, two other trials are currently recruiting candidates."
Answered by AI
Does my profile fit the requirements to join this research trial?
"To qualify for this research, persons must have had a lower limb amputation and be between 18 to 70 years old. The trial is presently looking to enrol 25 individuals with the aforementioned criteria."
Answered by AI
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