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NCT05425810 · ClinicalTrials.gov registry record · NA
R21: An Easy-to-use, iNtelligent, Affordable LinEr (ENABLE) System for Socket Fit Assessment
A NA study of Lower Limb Amputation Below Knee (Injury), sponsored by North Carolina State University.
- Recruiting
- Registry status
- NA
- Development phase
- 3
- Enrollment target
- 1
- Study location
NCT05425810: Recruiting NA study of Lower Limb Amputation Below Knee (Injury), sponsored by North Carolina State University.
NCT05425810 is a NA study of Lower Limb Amputation Below Knee (Injury) that is actively recruiting participants, run by North Carolina State University. The registered enrollment target is 3 participants, below the 81-participant average among 7 other Lower Limb Amputation Below Knee (Injury) trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05425810, a NA study of Lower Limb Amputation Below Knee (Injury), is actively recruiting participants, sponsored by North Carolina State University.
- RECRUITING
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
- 1
- Study location
Study Summary
Lower limb amputees (LLA) rely on their prosthetic legs to remain active and lead an independent life. For most LLAs, a well-fitted prosthetic socket is the only option to interface with their prosthetic leg, however, it is a real challenge to make a prosthetic socket to interface with residual limbs accurately. One of the reasons is that there lack of accurate approaches to evaluate the pressure distribution on the residual limb accurately and effectively. To overcome this issue, the research team will develop an innovative sensing system, which permits the prosthetists to track the pressure distribution on the residual limb visually. The capability of the new sensing system will be demonstrated on lower limb amputees.
Primary Outcome
Subjects are requested to fill a Wong-Baker Faces Pain Rating Scale to describe any discomfort experienced when the ENABLE system is used. This data will be used to validate that the ENABLE system is safe to use.
Conditions Studied
Interventions
- DEVICE Apply ENABLE sensing pad
- DEVICE Insert small pads at pressure tolerant locations
Study Locations (1)
North Carolina
- NC State University - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2021-04-20 |
| Est. Completion | 2026-02-27 |
| Phase | NA |
What NCT05425810 shows while recruiting
NCT05425810 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 81-participant average among 7 other Lower Limb Amputation Below Knee (Injury) trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Lower Limb Amputation Below Knee (Injury) appearing as the primary indexed condition, and to 2 interventions - of which Apply ENABLE sensing pad is the first listed.
NCT05425810 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05425810 about?
NCT05425810 is a clinical study titled "R21: An Easy-to-use, iNtelligent, Affordable LinEr (ENABLE) System for Socket Fit Assessment". Lower limb amputees (LLA) rely on their prosthetic legs to remain active and lead an independent life. For most LLAs, a well-fitted prosthetic socket is the only option to interface with their prosthetic leg, however, it is a real challenge to make a prosthetic socket to interface with residual limb...
What is the current status of trial NCT05425810?
This trial is currently recruiting. It is a NA study. The enrollment target is 3 participants. The study started on 2021-04-20. Estimated completion is 2026-02-27.
What conditions does trial NCT05425810 study?
This clinical trial studies the following conditions: Lower Limb Amputation Below Knee (Injury).
What interventions are being tested in trial NCT05425810?
The interventions under investigation include: Apply ENABLE sensing pad (DEVICE), Insert small pads at pressure tolerant locations (DEVICE).
Who is sponsoring clinical trial NCT05425810?
This trial is sponsored by North Carolina State University, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05425810 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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