Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-20

Study Completion Date

2026-12-31

Brief Summary

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The study will test a new approach to the design and implementation of socket and liner technology in individuals who lost a lower limb secondary to diabetes mellitus type II (herein referred to as dysvascular amputees). The technology-based intervention will be combined with an exercise program designed to improve the health status of dysvascular amputees.

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Detailed Description

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The study will test the hypothesis that the use of a digital approach to the design and implementation of socket and liner technology (herein referred to as "digital prosthetic interface technology") leads to better health of the residuum (compared to traditional socket and liner technology). This hypothesis will be tested by recruiting a group of dysvascular amputees (herein meant to refer to individuals who lost a lower limb secondary diabetes mellitus type II) and by randomizing them to either receiving a digital prosthetic interface technology or a traditional socket and liner system. Furthermore, the study will assess if the digital prosthetic interface technology improves adherence to an exercise program and results in better clinical outcomes. To test this hypothesis, an exercise intervention will be deployed by relying on coaching and mobile health technology to encourage adherence to a walking program targeting dysvascular transtibial amputees. This exercise intervention is an extension of pilot work that demonstrated the suitability of mobile health technology to implement an exercise-based intervention program in dysvascular amputees.

Conditions

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Diabete Type 2 Amputation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Study participants will be randomized to one of two groups: group 1 will use the digital prosthetic interface technology developed by Bionic Skins and group 2 will use a traditional socket-liner technology (i.e., study participants will use their own liner and socket system).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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digital prosthetic interface technology group

Study participants randomized to this group will use the digital prosthetic interface technology developed by Bionic Skins.

Group Type EXPERIMENTAL

digital prosthetic interface technology

Intervention Type DEVICE

Individuals randomized to this group will receive a socket and liner that are manufactured using a novel technique meant to achieve a better distribution of pressure on the residuum. The study is based on the hypothesis that an improvement in pressure distribution on the residuum will enable high adherence to an exercise program meant to improve health status in dysvascular amputees.

traditional socket and liner technology group

Study participants randomized to this group will use a traditional socket-liner technology (i.e., study participants will use their own liner and socket system).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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digital prosthetic interface technology

Individuals randomized to this group will receive a socket and liner that are manufactured using a novel technique meant to achieve a better distribution of pressure on the residuum. The study is based on the hypothesis that an improvement in pressure distribution on the residuum will enable high adherence to an exercise program meant to improve health status in dysvascular amputees.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Unilateral transtibial amputation within the past 4-16 months
* Etiology secondary to complications of Diabetes Mellitus (DM) type II
* Current use of a prosthesis, with at least 2 months prior use
* K2 or K3 level (as determined using the Amputee Mobility Predictor assessment tool)
* Own a smartphone

Exclusion Criteria

* Amputation due to cancer or macrotrauma or acute hemorrhage
* Bilateral amputation
* Medically or surgically unstable contralateral lower extremity as determined by medical criteria (e.g., critical limb ischemia)
* Severe residual limb pain that limits function preventing participation in an exercise-based program
* Medical conditions that would interfere with subject's participation in regular sustained exercise
* Anthropometric characteristics that are not compatible with the technology used to scan the residuum and manufacture the liner and socket (e.g., a residuum circumference greater than 32 inches would not be compatible with the device used to scan the residuum)
* Current pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No