Transtibial AmputationPhase 1NCT07216183
Epidermal Sensors for Wireless and Enhanced Amputee Skin Tracking (E-SWEAT) Part 1
A Phase 1 study testing Walk, Yuga post and E-SWEAT Sensor in people with Transtibial Amputation, run by North Carolina State University at 1 site in United States.
Trial summary
The goal of this clinical trial is to 1) demonstrate the feasibility of monitoring pressure, temperature, and lactic acid density of sweat inside the prosthetic socket, and 2) verify the relationship between mechanical pressure and Lactic acid density of sweat for lower limb amputees among transtibial amputees. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Transtibial Amputation
- What is being tested?
- Walk, Yuga post and E-SWEAT Sensor
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2025to 30 Jul 2029
- Phase
- Phase 1
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18 years or older
- Have a unilateral lower limb amputee (below the knee). The tibial length on the residual limb must be greater than half of the length of the tibial on the unaffected side
- Have an amputation that occurred over 2 years ago
- Have at least 1 year of experience using your prosthetic leg
- Have used the current socket for at least 6 months without a significant skin issue or major modification
- Be able to comfortably walk 6 mins (with prosthetic legs) without pausing to rest
- Be willing to come to North Carolina State University's Centennial Campus to participate in research and be photographed while doing research activities
Who cannot join
- Have a cognitive or visual impairment that affects the participant's ability to provide informed consent or to follow simple instructions during the experiments
- Have any neuropathy observed on the residual limb
- Experience numbness, tingling, muscle weakness, and/or pain in your residual limb
- Weigh more than 300lbs
- Do not want to take photos
- Are pregnant or plan to get pregnant
- Are allergic to latex, which is often contained in medical tapes.
- If you are using medication to control sweat on your residual limb, and your medical provider does not think that it is OK to avoid these medications for 48 hours.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Engineering Build III
Raleigh, North Carolina, 27695
Ming Liu, PhD, 919-515-8541, mliu10@ncsu.edu
About this study
The goal of this clinical trial is to 1) demonstrate the feasibility of monitoring pressure, temperature, and lactic acid density of sweat inside the prosthetic socket, and 2) verify the relationship between mechanical pressure and Lactic acid density of sweat for lower limb amputees among transtibial amputees. The main questions it aims to answer are:
- Is it feasible to reliably monitor pressure, temperature, and lactic acid density inside the prosthetic sockets simultaneously?
- Will the lactic acid density increase with higher pressure exposure? The participants are expected to wear the newly developed E-SWEAT system on their residual limb and are exposed to two activities, walk which generate mechanical load on the residual limb, and a yoga post - birddog, which does not generate mechanical loading on the residual limb. The E-SWEAT will measure pressure, temperature, and lactic acid density of sweat during these tasks.
- Conditions
- Transtibial Amputation
- Being tested
- Walk, Yuga post, E-SWEAT Sensor
- Keywords
- sweat biomarker, prosthetic socket, pressure ulcer, residual limb health
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalkProcedure or surgery
Treadmill walking
Yuga postProcedure or surgery
Participants conduct a yuga post which involves their efforts but not load on their residual limbs
E-SWEAT SensorDevice
Mounting the E_SWEAT sensor to monitor the lactic density, pressure, and temperature inside the socket
| Study group | Role | What they receive |
|---|---|---|
| Normal walking | Experimental | Participants walk on a treadmill with user preferred speed. Receives: Procedure: Walk; Device: E-SWEAT Sensor |
| No load excise - Yuga post | Active comparator | Participants conduct a yuga post which involves their efforts but not load on their residual limbs Receives: Procedure: Yuga post; Device: E-SWEAT Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactic acid density
amount of lactic acid in sweat
Measured: periprocedural in the first visit
Secondary outcomes (2)
Socket environment - temperature
temperature at the location where the E-SWEAT is mounted
Measured: periprocedural in the first visit
Socket environment - pressure
Pressure measured at the location where the E-SWAET is mounted
Measured: periprocedural in the first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start16 Sep 2025
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transtibial 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 1
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The participants are exposed to the two tasks in randomly decided sequence.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Carolina State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Amay Bandodkar, North Carolina State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216183
- Sponsor's protocol ID
- 26923
- Other IDs
- HT9425-24-1-0579
- Status last verified
- Oct 2025
- First submitted
- 11 Sep 2025
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: All data will be coded with an ID, which randomly generated.