Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees

April 22, 2026 updated by: Paolo Bonato, Spaulding Rehabilitation Hospital

Improving the Health Status of Dysvascular Amputees by Deploying Digital Prosthetic Interface Technology in Combination With an Exercise Intervention

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02129
        • Spaulding Rehabilitation Hospital Boston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Unilateral transtibial amputation within the past 6 years
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: digital prosthetic interface technology group
Study participants randomized to this group will use the digital prosthetic interface technology developed by Bionic Skins.
Device: 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.
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in intra-socket interface pressure between the two groups
Time Frame: Baseline
Pressure sensors inserted in the socket will be used to measure the pressure on the residuum when study participants are weight bearing. The pressure is measured in kilopascals (kPa). 1 kPa is approximately the pressure exerted by a 10-g mass resting on a 1-cm2 area.
Baseline
Difference in step counts between the two groups
Time Frame: 12 months
The average number of steps over a period of 2 weeks will be provided by a wearable sensor (Oura ring). The data will be expressed in number of steps per day.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in thermal imaging measures of the temperature of the residuum in the two groups
Time Frame: Baseline
A thermal camera will be used to measure the peak temperature of the residuum. The residuum temperature will be measured in degrees Celsius.
Baseline
Difference in Socket Evaluation Questionnaire (SEQ) scores in the two groups
Time Frame: Baseline
The Socket Evaluation Questionnaire (SEQ) consists of a battery of questions inquiring about subject's comfort using a socket. The SEQ uses a visual analog scale format. The output ranges from 0 (worst) to 100 (best).
Baseline
Difference in Prosthesis Evaluation Questionnaire (PEQ) scores in the two groups
Time Frame: Baseline
The Prosthesis Evaluation Questionnaire (PEQ) consists of a battery of questions inquiring about subject's perception of his/her prosthesis. The PEQ uses a visual analog scale format. The output ranges from 0 (worst) to 100 (best).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Spaulding Rehabilitation Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Bionic Skins LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paolo Bonato, PhD, Spaulding Rehabilitation Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022P003160
  • R44HD110327 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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