A Phase 2 interventional study of digital prosthetic interface technology in Diabetes Type 2 and Amputation, sponsored by Spaulding Rehabilitation Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Spaulding Rehabilitation Hospital · Phase 2, Interventional, and Treatment
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.
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 38 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Spaulding Rehabilitation Hospital is the lead sponsor of 114 studies on the registry; 26 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.
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Exclusion Criteria:
Study participants randomized to this group will use the digital prosthetic interface technology developed by Bionic Skins.
Device: digital prosthetic interface technology
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.
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.
Time frame: 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.
Time frame: 12 months
Difference in thermal imaging measures of the temperature of the residuum in the two groups
A thermal camera will be used to measure the peak temperature of the residuum. The residuum temperature will be measured in degrees Celsius.
Time frame: Baseline
Difference in Socket Evaluation Questionnaire (SEQ) scores in the two groups
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).
Time frame: Baseline
Difference in Prosthesis Evaluation Questionnaire (PEQ) scores in the two groups
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).
Time frame: Baseline
Plan to share: No
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This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Spaulding Rehabilitation Hospital