Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees

NCT05656924 | Active Not Recruiting Phase 2 FDA Device

• 2 other identifiers: 2022P003160R44HD110327
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Type 2; Amputation

Outcome Measures

Primary Outcomes (2)

• Difference in intra-socket interface pressure between the two groups

  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

  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 Outcomes (3)

• Difference in thermal imaging measures of the temperature of the residuum in the two groups

  Baseline

• Difference in Socket Evaluation Questionnaire (SEQ) scores in the two groups

  Baseline

• Difference in Prosthesis Evaluation Questionnaire (PEQ) scores in the two groups

  Baseline

Study Arms (2)

digital prosthetic interface technology group

EXPERIMENTAL

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

Device: digital prosthetic interface technology

traditional socket and liner technology group

NO INTERVENTION

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).

Interventions

digital prosthetic interface technology 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.

digital prosthetic interface technology group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• Bionic Skins LLC: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Spaulding Rehabilitation Hospital Boston

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Paolo Bonato, PhD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Motion Analysis Laboratory

Model Details: 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).

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 19, 2022
• Study Start: December 20, 2023
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)