Trial Outcomes & Findings for Patient Specific 3D Printed Diabetic Insoles to Reduce Plantar Pressure (NCT NCT05301478)
NCT ID: NCT05301478
Last Updated: 2026-06-01
Results Overview
pressure on the bottom of the feet between insole conditions
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
all interventions will be assessed in the second study visit ~ 1 month after the first
Results posted on
2026-06-01
Participant Flow
Clinician Referral - a clinician informs patients about the study and the patient agrees to be contacted about it.
Participant milestones
| Measure |
Diabetic With Elevated Plantar Pressure
Diabetic with elevated plantar pressure
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Diabetic With Elevated Plantar Pressure
Diabetic with elevated plantar pressure
|
|---|---|
|
Overall Study
did not have an area of high pressure
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Diabetic With Elevated Plantar Pressure
n=25 Participants
Diabetic with elevated plantar pressure
|
|---|---|
|
Age, Continuous
|
73.6 years
STANDARD_DEVIATION 6.3 • n=25 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=25 Participants
|
|
Plantar pressure in the area of high pressure
|
236.75 kPa
STANDARD_DEVIATION 60.95 • n=25 Participants
|
PRIMARY outcome
Timeframe: all interventions will be assessed in the second study visit ~ 1 month after the firstpressure on the bottom of the feet between insole conditions
Outcome measures
| Measure |
Diabetic With Elevated Plantar Pressure
n=25 Participants
Diabetic with elevated plantar pressure
|
|---|---|
|
Plantar Pressure - Standard of Care
|
202.71 kPa
Standard Deviation 56.48
|
PRIMARY outcome
Timeframe: ~1 monthpressure on the bottom of the feet between insole conditions
Outcome measures
| Measure |
Diabetic With Elevated Plantar Pressure
n=25 Participants
Diabetic with elevated plantar pressure
|
|---|---|
|
Plantar Pressure - Finite Element Insole
|
152.69 kPa
Standard Deviation 46.88
|
PRIMARY outcome
Timeframe: ~1 monthpressure on the bottom of the feet between insole conditions
Outcome measures
| Measure |
Diabetic With Elevated Plantar Pressure
n=25 Participants
Diabetic with elevated plantar pressure
|
|---|---|
|
Plantar Pressure - Pressure Based Insole
|
156.50 kPa
Standard Deviation 61.35
|
Adverse Events
Diabetic With Elevated Plantar Pressure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place