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Prosthetics

Digital Prosthetics + Exercise for Diabetic Amputation

Phase 2

Recruiting

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)

Must not have

Bilateral amputation

Medically or surgically unstable contralateral lower extremity as determined by medical criteria (e.g., critical limb ischemia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had both of my limbs amputated.

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My other leg is medically unstable due to severe circulation problems.

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I have had an amputation because of cancer, a major injury, or severe bleeding.

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I have severe pain in my amputated limb that stops me from exercising.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in intra-socket interface pressure between the two groups

Difference in step counts between the two groups

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 6Eligibility criteria met