Sponsor study identifier
Secondary identifiers
NIH
interventional
38
1 country
1
Study Start
December 20, 2023
Actual (reported)Primary Completion
February 28, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 8, 2022
Actual (reported)December 19, 2022
Actual (reported)December 20, 2023
Actual (reported)February 28, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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 participants randomized to this group will use the digital prosthetic interface technology developed by Bionic Skins.
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).
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Spaulding Rehabilitation Hospital Boston
Boston, Massachusetts, 02129, United States
Paolo Bonato, PhD
Spaulding Rehabilitation Hospital
First Submitted
December 8, 2022
First Posted
December 19, 2022
Study Start
December 20, 2023
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
February 28, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 28, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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