Trial Summary
What is the purpose of this trial?
The goal of this project is to understand the factors that affect skin temperature (e.g., tissue above amputation site, and opposite foot) in people with amputation and diabetes. This project will also test the effects of 'shock-absorbing' prosthesis on skin temperature responses.
Research Team
KT
Kota Takahashi
Principal Investigator
University of Utah
Eligibility Criteria
This trial is for individuals with an amputation and diabetes, focusing on how their skin temperature changes. Details about who can join or reasons why someone might not be able to participate are not provided.Inclusion Criteria
I can walk for 10 minutes without feeling overly tired.
I have one leg amputated below the knee.
I can walk over curbs, stairs, or uneven surfaces without help.
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Exclusion Criteria
I have a condition like stroke or Parkinson's that affects my ability to walk.
I have a history of inflammatory diseases like Raynaud's or rheumatoid arthritis.
Treatment Details
Interventions
- Shock-absorbing Prosthesis (Prosthesis)
Trial OverviewThe study investigates the impact of a 'shock-absorbing' prosthesis on skin temperature in people with an amputation and diabetes, aiming to understand thermoregulation above the site of amputation and on the opposite foot.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Shock-absorbing PylonExperimental Treatment1 Intervention
The prosthesis will be given a commercial prosthetic foot and a compressive 'shock-absorbing' pylon that connects the prosthetic foot to the socket.
Group II: Rigid PylonExperimental Treatment1 Intervention
The prosthesis will be given a commercial prosthetic foot and a rigid pylon that connects the prosthetic foot to the socket.
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Who Is Running the Clinical Trial?
University of Utah
Lead Sponsor
Trials
1,169
Recruited
1,623,000+