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Using Direct Molding Socket Technology for Trans-tibial Prosthesis in Developing Regions

NCT04679701 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 27

Last updated 2020-12-22

No results posted yet for this study

Summary

The study aims to understand how well CPOs and amputees can adapt to using the Amparo socket technology. CPOs at the APDK and The Cure will be trained to use the Amparo socket technology then use it with their consenting patients for a span of 7 months. Survey information will be collected along the way to assess how well the product is adapted by CPOs and patients.

Conditions

  • Transtibial Amputees

Interventions

DEVICE

Amparo Confidence Socket

The Amparo Confidence Socket technology takes a different approach by starting with a prefabricated socket (https://www.amparo.world/confidence-socket-en). The socket is made from a moldable thermoplastic and has the attachment point pre-assembled. This prefabricated socket is essentially an "off-the-shelf" product that can be heated, then molded directly to the patient's residual limb. This removes many of the intermediate steps in traditional socket fabrication. The product's molding temperature is between 60-70 ˚C but the insulation of a silicone liner between the plastic and limb ensures safe temperatures for the patient. This process is currently used in several workshops in Europe and with approximately 50 patients currently using the product. In general, it has been shown to be safe and effective in creating below-knee prosthesis.

Sponsors & Collaborators

  • GDI Hub

    collaborator UNKNOWN

  • AT 2030

    collaborator UNKNOWN

  • Amparo GmbH

    lead INDUSTRY

Principal Investigators

  • Giulia Barbareschi, PhD · Researcher GDI hub

  • Catherine Holloway · Cofounder GDI Hub, Associate Professor UCL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-08
Primary Completion
2020-03-12
Completion
2020-11-30

Countries

  • Kenya

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 NCT04679701 on ClinicalTrials.gov