An interventional study of Clinical Evaluation and Plantar Pressure Biofeedback Gait Training in Diabetic Peripheral Neuropathy and Diabetes Mellitus, sponsored by Florida Institute for Human and Machine Cognition. Recruiting at 1 site in United States. Open to participants aged 45 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by Florida Institute for Human and Machine Cognition · Not applicable, Interventional, and Basic science
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Among 3,022 studies in Diabetes Mellitus with a site in United States — 289 open to participants now, 390 under way, 12 of them phase 3. Diabetes Mellitus · United States.
Among the 3,022 studies in Diabetes Mellitus with a site in United States, this one is the 1,924th largest by planned enrollment of the 2,501 interventional ones that give a count, is one of 83 that started in 2025, is one of 1,417 with no phase, reaches primary completion later than 184 of the 382 other live ones, and was the 2,823rd registered.
8,292 studies on the registry are indexed under Diabetes Mellitus; 1,074 are open to participants now.
Browse Diabetes Mellitus studies →289 of the 3,022 studies in Diabetes Mellitus with a site in United States are open now. Recruiting first, the newest first:
Bettina Mittendorfer · Sites in United States
Ages 18–100 · Healthy volunteers
University of California, Los Angeles · Sites in United States
Ages 18+
Wayne State University · Sites in United States
Ages 16–20
Mayo Clinic · Sites in United States
Ages 18+
Pfizer · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 650 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 197 (30%) stop at 75 or younger; 88 take children under 18; 183 take healthy volunteers.
This study: 45 Years to 90 Years · all sexes · no healthy volunteers.
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3,022 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 262 · Phase 2 371 · Phase 3 340 · Phase 4 215
First in 1976; this study’s year is marked. 83 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 25 is below the median of 80 across 6,024 interventional studies indexed under Diabetes Mellitus.
Median enrollment 82 across the 2,501 interventional studies, 159 across the 499 observational. Of the 2,396 that completed or were terminated, 990 (41%) have results posted.
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852 of 3,022 have an industry lead sponsor. The 10 most frequent:
Florida Institute for Human and Machine Cognition is the lead sponsor of 9 studies on the registry; 6 are open to participants now.
Florida Institute for Human and Machine Cognition has 2 studies filed under Diabetes Mellitus — fewer than ten, so there is no comparison to draw.
141 of the studies in Diabetes Mellitus with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03982693Phase 3Mt. Sinai Medical Center, MiamiTrial to Assess Chelation Therapy in Critical Limb Ischemia | 2026-12 |
| NCT05174052Phase 3University of OklahomaDapagliflozin in Patients With Atrial Fibrillation (DAPA-AF) | 2027-04 |
| NCT02262832Phase 3National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy | 2027-07-31 |
| NCT07400653Phase 3PfizerA Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D) | 2027-10-12 |
| NCT07556354University of Alabama at BirminghamEmpowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City | 2026-11 |
Add all 141 to your calendar (.ics) → With an account.
Among the 3,022 studies in Diabetes Mellitus with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study aims to collect data to improve gait function in individuals with Diabetic Peripheral Neuropathy (DPN).
The primary goals are to evaluate:
The participants will be required to complete
Over 38 million adults in the United States (\~1 in 7) are living with Diabetes Mellitus (DM), of which diabetic peripheral neuropathy (DPN) is the most common complication, affecting more than 50% of individuals with DM. DPN causes both sensory and motor impairments of the foot and ankle, leading to reduced functional mobility and increased ulceration and amputation risk. Propulsion and plantar pressure are two key interrelated gait parameters contributing to walking function and ulceration risk, respectively. Real-time biofeedback is a non-invasive rehabilitation strategy with significant promise for targeting gait impairments by providing the user with quantitative information regarding a targeted performance variable.
In this study, the team will evaluate multi-joint lower extremity biomechanical responses to univariate propulsion and plantar pressure biofeedback. Secondly, the team will use identified biomechanical compensations to propulsion and plantar pressure biofeedback to develop a multi-variable, implicit, individualized visual biofeedback program to improve gait function in individuals with DPN. Insights into the biomechanical mechanisms underlying plantar pressure and propulsion in people with DPN will allow us to design more informed and effective gait rehabilitation interventions aimed at preventing deleterious outcomes such as ulceration and amputation that can be tailored to individual patient characteristics.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Real-time biofeedback of propulsion and plantar pressure to measure the immediate effects of biofeedback on walking function and gait mechanics. Permuted block randomization (blocks of 4) will be used to allocate the order of the biofeedback stimulus (plantar pressure-intervention A or propulsion-intervention B). Participants will receive both interventions in session 3, but the order will be randomized.
Other: Clinical Evaluation · Other: Plantar Pressure Biofeedback Gait Training · Other: Propulsion Biofeedback Gait Training
A clinical evaluation occurs at the first study session. The clinical evaluation assesses walking function and mobility, lower extremity, sensation, health-related quality of life (HRQoL) and foot function. Session 2 will be a dynamometer-based evaluation of passive ankle stiffness and a 3-dimensional gait analysis to evaluate baseline biomechanics. During Session 3, real-time biofeedback conditions will be used to measure the immediate effects on walking function.
Participants will complete a 3-dimensional gait evaluation prior to training, after a 6-minute control bout without biofeedback, and following three 6-minute biofeedback training bouts (total 18-minutes). Individualized biofeedback targets will be calculated from each participant's immediate biofeedback session to best minimize plantar pressure whilst maintaining or enhancing propulsion. Audio-visual biofeedback is provided using a screen placed in front of the treadmill and a speaker. For plantar pressure biofeedback, a visual display of a foot with a colored heat map represents the current plantar pressure, in addition to bar graphs representing real-time movement of plantar pressure in specific areas of the foot. A target is provided using the heat map colors of red and target line on the bar graph. Participants are informed that the target is a measurement of the pressure under their foot, and their goal is to decrease pressure to achieve their target
Also known as: Intervention A
Participants will complete a 3-dimensional gait evaluation prior to training, after a 6-minute control bout without biofeedback, and following three 6-minute biofeedback training bouts (total 18-minutes). Individualized biofeedback targets will be calculated from each participant\'s immediate biofeedback session to best minimize plantar pressure whilst maintaining or enhancing propulsion. Audio-visual biofeedback is provided using a screen placed in front of the treadmill and a speaker. For propulsion biofeedback, a visual display with a marker represents the current propulsion (peak AGRF) and a target provided to modulate propulsion. Participants are informed that the marker is a measurement of how hard they are pushing the ground backward, and their goal is to push-off more to achieve their target.
Also known as: Intervention B
Biomechanical plantar pressure
Plantar pressure is calculated in kilopascals (kPa) using a force sensor placed between the participant's foot and insole of their shoe. The peak plantar pressure in regions of interest (forefoot) will be calculated.
Time frame: Study Session 2 (occurs 24 hours up to 2 weeks after Session 2)
Biomechanical Propulsion
Propulsion is calculated as the maximum anteriorly directed ground reaction force during the stance phase of gait using the instrumented (force plate) treadmill.
Time frame: Study Session 2 (occurs 24 hours up to 2 weeks after Session 2)
Changes induced by biofeedback in plantar pressure
Plantar pressure measurements will be recorded using insoles placed between the surface of the foot and the insole of the participant's shoe. Marker data, GRFs, and plantar pressure data will be synchronized.
Time frame: Study Session 3 (occurs 24 hours up to 2 weeks after Session 3)
Changes induced by biofeedback in propulsion
Ground reaction force (GRF) data will be collected independently from each leg using a split-belt treadmill instrumented with two 6-degree of freedom force platforms. The antero-posterior GRFs (AGRF) will be used to compute propulsion.
Time frame: Study Session 3 (occurs 24 hours up to 2 weeks after Session 3)
Changes induced by biofeedback in biomechanics during gait
Lower extremity kinetics and kinematics will be measured using a three-dimensional motion analysis system and split-belt instrumented treadmill. Kinetics and kinematics of the ankle, knee, and hip will be analyzed during gait.
Time frame: Study Session 3 (occurs 24 hours up to 2 weeks after Session 3)
Plan to share: Yes — Data on demographics, medical history, clinical evaluation, questionnaires, walking biomechanics, and plantar pressure data will be collected from individuals (N = 25) with diabetic peripheral neuropathy. Subject-level de-identified data will be preserved and shared in raw and pre-processed forms in ".csv" and ".xlsx" format. Biomechanics data will be processed and saved in ".c3d" formatted files as per standard practice in the field of biomechanics.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: All data will be deposited 6 months following the completion of the study. At a minimum, the data will be made available for 3 years after the completion of the study.
Access criteria: Raw and pre-processed data will be archived through the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH). Processed biomechanics data will be archived through SimTK. The archived data will be assigned digital object identifiers (DOI). Both NICHD DASH and SimTK are made available through web-accessible repositories at no cost to users.
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Jun 2027, 19 months after the start.
Of 1,586 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 19 months is below that.
Counting every sponsor, half of 1,746 studies reached it within 21 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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Florida Institute for Human and Machine Cognition