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Prosthetics

Digital Prosthetics + Exercise for Diabetic Amputation

Phase 2

Waitlist Available

Led By Paolo Bonato, PhD

Research Sponsored by Spaulding Rehabilitation Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Etiology secondary to complications of Diabetes Mellitus (DM) type II

K2 or K3 level (as determined using the Amputee Mobility Predictor assessment tool)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial tests a new tech+exercise approach to improve health in people with diabetes-related lower limb loss.

Who is the study for?

This trial is for individuals with a lower limb amputation due to type 2 diabetes complications, who currently use a prosthesis and own a smartphone. They should be able to move at certain levels (K2 or K3) and have had their amputation within the last 4-16 months. People with bilateral amputations, unstable other limbs, conditions preventing exercise, current pregnancy, incompatible body measurements for technology use, or severe limb pain are excluded.Check my eligibility

What is being tested?

The study examines new socket and liner technology in digital prosthetic interfaces combined with an exercise program aimed at improving health in people who've lost a lower limb from diabetes-related issues. Participants will try out this tech-and-exercise combo to see how well it works.See study design

What are the potential side effects?

Potential side effects may include discomfort or skin issues related to the new prosthetic interface technology and typical risks associated with starting an exercise regimen such as muscle soreness or strain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition is due to complications from Type 2 Diabetes.

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My mobility level is rated K2 or K3.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Difference in intra-socket interface pressure between the two groups

Difference in step counts between the two groups

Secondary outcome measures

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

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

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: digital prosthetic interface technology groupExperimental Treatment1 Intervention

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

Group II: traditional socket and liner technology groupActive Control1 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).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor

134 Previous Clinical Trials

10,977 Total Patients Enrolled

Bionic Skins LLCUNKNOWN

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,963 Previous Clinical Trials

2,674,703 Total Patients Enrolled

Media Library

Digital Prosthetic Interface Technology (Prosthetics) Clinical Trial Eligibility Overview. Trial Name: NCT05656924 — Phase 2

Amputation Research Study Groups: digital prosthetic interface technology group, traditional socket and liner technology group

Amputation Clinical Trial 2023: Digital Prosthetic Interface Technology Highlights & Side Effects. Trial Name: NCT05656924 — Phase 2

Digital Prosthetic Interface Technology (Prosthetics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05656924 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the protocol for this research extend to individuals aged 75 and over?

"The lower bound for admission into this study is 18 years of age, while the upper limit is 70."

Answered by AI

Are applications for participation in this clinical experiment still being accepted?

"According to the clinicaltrials.gov website, this particular trial has paused enrollment at present; its initial posting date was January 1st 2023 and it last had an update on December 8th 2022. Despite that, there are currently 954 other studies actively seeking participants right now."

Answered by AI

Has the FDA issued a verdict on digital prosthetic interface technology?

"In light of the Phase 2 trial data currently available, our team has assigned a safety rating of 2 to digital prosthetic interface technology. This denotes that there is some evidence for its security but none yet for its efficacy."

Answered by AI

Who would be considered an eligible participant for this experiment?

"This study seeks to recruit 38 individuals with type 2 diabetes mellitus aged 18-70. Key requirements include: unilateral transtibial amputation 4-16 months before application, complications of DM II as etiology, two or more months use of a prosthesis, Amputee Mobility Predictor assessment tool grading K2 or K3 level, and possession of a smartphone."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees

Paolo Bonato 2023. "Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05656924.