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NCT07216183 · ClinicalTrials.gov registry record · Phase 1
Epidermal Sensors for Wireless and Enhanced Amputee Skin Tracking (E-SWEAT) Part 1
A Phase 1 study of Transtibial Amputation, sponsored by North Carolina State University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT07216183: Recruiting Phase 1 study of Transtibial Amputation, sponsored by North Carolina State University.
NCT07216183 is a Phase 1 study of Transtibial Amputation that is actively recruiting participants, run by North Carolina State University. The registered enrollment target is 16 participants, below the 33-participant average among 4 other Transtibial Amputation trials with a reported enrollment target (52% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07216183, a Phase 1 study of Transtibial Amputation, is actively recruiting participants, sponsored by North Carolina State University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Primary Outcome
amount of lactic acid in sweat
Conditions Studied
Interventions
- PROCEDURE Walk
- PROCEDURE Yuga post
- DEVICE E-SWEAT Sensor
Study Locations (1)
North Carolina
- Engineering Build III - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2025-09-16 |
| Est. Completion | 2029-07-30 |
| Phase | Phase 1 |
What NCT07216183 shows while recruiting
NCT07216183 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 33-participant average among 4 other Transtibial Amputation trials with a reported enrollment target (52% lower).
The record links to 1 condition, with Transtibial Amputation appearing as the primary indexed condition, and to 3 interventions - of which Walk is the first listed.
NCT07216183 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT07216183 about?
NCT07216183 is a clinical study titled "Epidermal Sensors for Wireless and Enhanced Amputee Skin Tracking (E-SWEAT) Part 1". 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 transtibi...
What is the current status of trial NCT07216183?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2025-09-16. Estimated completion is 2029-07-30.
What conditions does trial NCT07216183 study?
This clinical trial studies the following conditions: Transtibial Amputation.
What interventions are being tested in trial NCT07216183?
The interventions under investigation include: Walk (PROCEDURE), Yuga post (PROCEDURE), E-SWEAT Sensor (DEVICE).
Who is sponsoring clinical trial NCT07216183?
This trial is sponsored by North Carolina State University, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07216183 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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