AmputationNCT06458426
Thermoregulation in Individuals With a Leg Amputation
A study testing shock-absorbing prosthesis in people with Amputation and Diabetes, run by University of Utah at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amputation, Diabetes
- What is being tested?
- shock-absorbing prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals with a unilateral transtibial amputation, divided into two groups (with and without diabetes)
- Participants must classify as Medicare class K2 or higher (who can traverse low-level environmental barriers such as curbs, stairs or uneven surfaces).
- Participants must have undergone amputation at least 6 months prior.
- They must have the ability to walk for at least 10 continuous minutes without undue fatigue.
Who cannot join
- Neurological impairment that may affect walking function, such as stroke, severe traumatic brain injury, Parkinson's disease, and multiple sclerosis.
- History of inflammatory diseases, such as Raynaud's syndrome or rheumatoid arthritis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Thermoregulation in Individuals With a Leg Amputation: Mechanics and Vascular Physiology Factors to Understand Risks for Tissue Complications
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.
Read the detailed description
The overall goal of this project is to understand the factors that affect impaired temperature control in individuals with a leg amputation for areas vulnerable to damage, such as the tissue above the amputation site and the opposite intact foot. Abnormal tissue temperature is associated with risks for tissue damage, such as ulcers and pressure sores, especially in people with diabetes. In this study, we aim to study the effects of biomechanics and vascular physiology on tissue temperature responses. We will also determine the effectiveness of prosthetic shock-absorbing components in protecting the tissue from damage.
It is hypothesized that the temperatures of tissues above the amputation site and in the opposite intact foot are associated with mechanical factors during walking, such as shear forces and work (i.e., energy). It is also hypothesized that impaired temperature regulation, especially in people with diabetes, is associated with poor vascular function that inhibits effective blood circulation and oxygen delivery to affected tissues. Lastly, it is hypothesized that walking with a shock-absorbing prosthetic component can improve comfort and improve temperature regulation of tissues above the amputation site.
This project will recruit 40 individuals with a unilateral transtibial (below-knee) amputation, divided into two groups: with and without diabetes. All individuals will be given two sets of prostheses: with and without a shock-absorbing pylon (SAP). SAP is a modular prosthetic component that connects the socket and the foot components and allows added compression and twisting along the pylon. In both sets of prostheses conditions, the participants will wear the same foot component provided by the research team. For each of the two sets of prostheses (with and without SAP), the participants will make up to 5 visits to the laboratory (i.e., up to 10 total visits for the entire protocol). Each visit will involve data collections under a variety of walking tasks, such as walking on various slopes and turning. The same data collections will be repeated with the other set of prostheses.
- Conditions
- Amputation, Diabetes
- Being tested
- shock-absorbing prosthesis
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shock-absorbing prosthesisDevice
the intervention will test the difference between rigid and shock-absorbing pylons, while the same prosthetic foot is applied in each condition.
| Study group | Role | What they receive |
|---|---|---|
| Rigid Pylon | Experimental | The prosthesis will be given a commercial prosthetic foot and a rigid pylon that connects the prosthetic foot to the socket. Receives: Device: shock-absorbing prosthesis |
| Shock-absorbing Pylon | Experimental | The prosthesis will be given a commercial prosthetic foot and a compressive 'shock-absorbing' pylon that connects the prosthetic foot to the socket. Receives: Device: shock-absorbing prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking mechanics
Mechanics of walking will be collected using a high-speed motion capture system and force-sensing platforms, which will quantify the motion of the legs and forces acting on the legs, respectively.
Measured: during the intervention/procedure/surgery
Vascular physiology - macrocirculation
Macrocirculation of the legs (i.e.,blood flow) will be recorded using a Doppler ultrasound probe secured over the thigh during walking
Measured: during the intervention/procedure/surgery
Vascular physiology - microcirculation
Microcirculation of the legs (i.e.,oxygen utility) will be recorded using near-infrared spectroscopy sensors placed on the thighs, calf, and top surface of the foot.
Measured: during the intervention/procedure/surgery
Temperature in lower limb
Temperatures of the skin above the amputation site and the opposite intact foot will be recorded using thermistors and a thermal imaging camera.
Measured: during the intervention/procedure/surgery
Comfort
Participants will complete a self-reported questionnaire to indicate comfort while walking with a prosthesis.
Measured: during the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start7 May 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kota Takahashi, University of Utah
- Investigators
- Kota Takahashi, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458426
- Sponsor's protocol ID
- 00155345
- Status last verified
- Aug 2025
- First submitted
- 6 Jun 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermoregulation in Individuals With a Leg Amputation: Mechanics and Vascular Physiology Factors to Understand Risks for Tissue Complications
- ClinicalTrials.gov ID
- NCT06458426
- Acronym / sponsor ID
- 00155345
- Conditions
- Amputation, Diabetes
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 7 May 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overall goal of this project is to understand the factors that affect impaired temperature control in individuals with a leg amputation for areas vulnerable to damage, such as the tissue above the amputation site and the opposite intact foot. Abnormal tissue temperature is associated with risks for tissue damage, such as ulcers and pressure sores, especially in people with diabetes. In this study, we aim to study the effects of biomechanics and vascular physiology on tissue temperature responses. We will also determine the effectiveness of prosthetic shock-absorbing components in protecting the tissue from damage.
It is hypothesized that the temperatures of tissues above the amputation site and in the opposite intact foot are associated with mechanical factors during walking, such as shear forces and work (i.e., energy). It is also hypothesized that impaired temperature regulation, especially in people with diabetes, is associated with poor vascular function that inhibits effective blood circulation and oxygen delivery to affected tissues. Lastly, it is hypothesized that walking with a shock-absorbing prosthetic component can improve comfort and improve temperature regulation of tissues above the amputation site.
This project will recruit 40 individuals with a unilateral transtibial (below-knee) amputation, divided into two groups: with and without diabetes. All individuals will be given two sets of prostheses: with and without a shock-absorbing pylon (SAP). SAP is a modular prosthetic component that connects the socket and the foot components and allows added compression and twisting along the pylon. In both sets of prostheses conditions, the participants will wear the same foot component provided by the research team. For each of the two sets of prostheses (with and without SAP), the participants will make up to 5 visits to the laboratory (i.e., up to 10 total visits for the entire protocol). Each visit will involve data collections under a variety of walking tasks, such as walking on various slopes and turning. The same data collections will be repeated with the other set of prostheses.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rigid Pylon | Experimental | Device: shock-absorbing prosthesisThe prosthesis will be given a commercial prosthetic foot and a rigid pylon that connects the prosthetic foot to the socket. |
| Shock-absorbing Pylon | Experimental | Device: shock-absorbing prosthesisThe prosthesis will be given a commercial prosthetic foot and a compressive 'shock-absorbing' pylon that connects the prosthetic foot to the socket. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals with a unilateral transtibial amputation, divided into two groups (with and without diabetes)
- Participants must classify as Medicare class K2 or higher (who can traverse low-level environmental barriers such as curbs, stairs or uneven surfaces).
- Participants must have undergone amputation at least 6 months prior.
- They must have the ability to walk for at least 10 continuous minutes without undue fatigue.
Key exclusion criteria (2 listed)
- Neurological impairment that may affect walking function, such as stroke, severe traumatic brain injury, Parkinson's disease, and multiple sclerosis.
- History of inflammatory diseases, such as Raynaud's syndrome or rheumatoid arthritis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shock-absorbing prosthesisthe intervention will test the difference between rigid and shock-absorbing pylons, while the same prosthetic foot is applied in each condition. | Device | Rigid Pylon, Shock-absorbing Pylon |
Primary outcome
Walking mechanics
Time frame: during the intervention/procedure/surgery
Mechanics of walking will be collected using a high-speed motion capture system and force-sensing platforms, which will quantify the motion of the legs and forces acting on the legs, respectively.
Vascular physiology - macrocirculation
Time frame: during the intervention/procedure/surgery
Macrocirculation of the legs (i.e.,blood flow) will be recorded using a Doppler ultrasound probe secured over the thigh during walking
Vascular physiology - microcirculation
Time frame: during the intervention/procedure/surgery
Microcirculation of the legs (i.e.,oxygen utility) will be recorded using near-infrared spectroscopy sensors placed on the thighs, calf, and top surface of the foot.
Temperature in lower limb
Time frame: during the intervention/procedure/surgery
Temperatures of the skin above the amputation site and the opposite intact foot will be recorded using thermistors and a thermal imaging camera.
Comfort
Time frame: during the intervention/procedure/surgery
Participants will complete a self-reported questionnaire to indicate comfort while walking with a prosthesis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients Using the Avior Knee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kota Takahashi principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shock-absorbing prosthesis in people with Amputation and Diabetes, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking mechanics (time frame: during the intervention/procedure/surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.