R21: An Easy-to-use, iNtelligent, Affordable LinEr (ENABLE) System for Socket Fit Assessment

NCT05425810 | Recruiting FDA Device

• 1 other identifier: 23949
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lower Limb Amputation Below Knee (Injury)

Keywords

amputee; prosthetic socket; residual skin; pressure ulcer

Outcome Measures

Primary Outcomes (1)

• Discomfort chart

  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.

  The outcome is to evaluate the comfort of the final visit for the project (4 hours).

Secondary Outcomes (1)

• Pressure distribution on the residual limb

  The outcome is to evaluate the real pressure on the residual limb in ten 60-second walking trials.

Study Arms (1)

Transtibial patient

EXPERIMENTAL

All the recruited participants will be included in this arm and will go through the socket manufacturing, fitting, and testing procedure.

Device: Apply ENABLE sensing pad; Device: Insert small pads at pressure tolerant locations

Interventions

Apply ENABLE sensing pad DEVICE

The developed ENABLE system is integrated into the standard prosthetic liner and measures the pressure distribution during locomotion. Using the ENABLE system may lead temporary increase in the temperature inside the prosthetic socket and it is expected that the total exposition during the experimental procedure will be less than 10 min.

Transtibial patient

Insert small pads at pressure tolerant locations DEVICE

To change the pressure distribution inside the socket, four fitting conditions are introduced by adding small pads at patella tendon (PT), lateral tibial crest (LTC), medial tibial crest (MTC), and popliteal fossa (PF) respectively. Including the no pads scenario, totally of five fitting conditions are simulated.

Transtibial patient

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral transtibial amputees
• At least 1 year of experience using his/her prosthetic leg
• Has used the current socket for at least 6 months without a significant skin issue or major modification
• Can comfortably walk 3 mins without pausing to rest
• The fibula length on the residual limb must be greater than half of the length of the fibula on the unaffected side

You may not qualify if:

• Cognitive or visual impairment that affects the participant's ability to provide informed consent or to follow simple instructions during the experiments
• neuropathy observed on the residual limb
• regnant female

Sponsors & Collaborators

• North Carolina State University: lead

Study Sites (1)

NC State University

Raleigh, North Carolina, 27695, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries; Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Ming Liu, PhD

CONTACT

9195158541; mliu10@ncsu.edu

He Huang, PhD

CONTACT

9195158541; hhuang11@ncsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: When the digital photos are shown to evaluators from external groups, the socket fitting conditions are not disclosed.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: All the participants will go through the same testing procedure. Both the experimenters and the participants know very well about the change in the experimental setup.

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: June 21, 2022
• Study Start: April 20, 2021
• Primary Completion: January 30, 2026
• Study Completion: February 27, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The information will be available 6 months after the end of the experimental procedure.
• Access Criteria: The statical analysis results will be available to the public with selected images collected from the experimental procedure. The full picture set will be available based on the request to the research team.

Locations

US (1)