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Low Cost Socket for Lower Limb Amputees

NCT04725461 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-06-17

No results posted yet for this study

Summary

The purpose of this research is to test an investigational fabrication system for transtibial prostheses. This fabrication method will be tested for comfort and function to determine feasibility of use for amputees in developing countries.

To address the need for high quality and affordable prosthetic technology in developing countries, the investigators have developed a simplified socket fitting protocol using expandable rigid foam. The foam is formed by mixing small amounts of two liquid components, which typically expands to several times its original volume.

Conditions

  • Amputation
  • Amputation; Traumatic, Limb
  • Amputation, Traumatic

Interventions

DEVICE

Low cost lower limb prosthetic socket

A pre-made 3D printed cylinder used as an outer shell is selected for each subject based on their measurements. The space between the residual limb and the outer shell will be filled with an expanding polyurethane foam (Foam IT 8, Smooth On Inc.) that conforms to the residual limb and bonds with the outer shell to form a strong and lightweight socket. The foam forms a smooth surface against the protective sheath; the socket is fully formed once the foam has hardened to the 3D printed cylinder. A prefabricated supracondylar suspension cuff made of Dacron or nylon, or a commercially available suspension sleeve may be will be applied to the prosthetic socket to aid in suspension. Commercially available components, including the International Committee of the Red Cross (ICRC) transtibial polypropylene component system will be attached to the bottom of the socket to allow the patient to ambulate in the prosthesis.

Sponsors & Collaborators

  • Shirley Ryan AbilityLab

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-06
Primary Completion
2024-01-11
Completion
2025-01-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04725461 on ClinicalTrials.gov