Diabetes Type 2Phase 2NCT05656924
Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees
A Phase 2 study testing digital prosthetic interface technology in people with Diabetes Type 2 and Amputation, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Type 2, Amputation
- What is being tested?
- digital prosthetic interface technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2023to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital Boston
Boston, Massachusetts, 02129
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Type 2, Amputation
- Being tested
- digital prosthetic interface technology
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital prosthetic interface technologyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| digital prosthetic interface technology group | Experimental | Study participants randomized to this group will use the digital prosthetic interface technology developed by Bionic Skins. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start20 Dec 2023
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bionic Skins LLC, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Paolo Bonato, Spaulding Rehabilitation Hospital
- Investigators
- Paolo Bonato, PhD, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656924
- Sponsor's protocol ID
- 2022P003160
- Other IDs
- R44HD110327
- Status last verified
- Apr 2026
- First submitted
- 8 Dec 2022
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Health Status of Dysvascular Amputees by Deploying Digital Prosthetic Interface Technology in Combination With an Exercise Intervention
- ClinicalTrials.gov ID
- NCT05656924
- Acronym / sponsor ID
- 2022P003160
- Conditions
- Diabetes Type 2, Amputation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Bionic Skins LLC, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| digital prosthetic interface technology group | Experimental | Device: digital prosthetic interface technologyStudy participants randomized to this group will use the digital prosthetic interface technology developed by Bionic Skins. |
| 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital prosthetic interface technologyIndividuals 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. | Device | digital prosthetic interface technology group |
Primary outcome
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.
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.
3 secondary outcomes
Difference in thermal imaging measures of the temperature of the residuum in the two groups
Time frame: Baseline
Difference in Socket Evaluation Questionnaire (SEQ) scores in the two groups
Time frame: Baseline
Difference in Prosthesis Evaluation Questionnaire (PEQ) scores in the two groups
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Bonato, PhD principal investigator
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing digital prosthetic interface technology in people with Diabetes Type 2 and Amputation, run by Spaulding Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in intra-socket interface pressure between the two groups (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.