Trial Outcomes & Findings for Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology (NCT NCT05968924)
NCT ID: NCT05968924
Last Updated: 2026-04-30
Results Overview
Participant adherence to use of SmartMat will be quantified by automated data collection. Adherence is defined as having conducted \>3 days foot scans per week (foot scans/week) over the six-month period. The median number of scans/week over a six-month period is reported.
COMPLETED
NA
20 participants
Up to six months following intervention
2026-04-30
Participant Flow
The study cohort was drawn from a regional referral center for diabetic foot complications, receiving referrals from vascular surgery, endocrinology, emergency room, primary care physicians, other podiatrists, orthopedics, infectious disease and home care nursing teams across multiple Montefiore Medical Center campus locations. The cohort was intended to reflect the broad racial, ethnic, and socioeconomic diversity of the Bronx, consistent with the borough's overall demographics.
Participant milestones
| Measure |
High Risk Diabetic Foot Ulcer (DFU)
Podimetrics smart map
Podimetrics SmartMat: Participants receive training for stepping on SmartMat each day for 6 months. Monthly phone calls will be conducted to assess foot health and mat.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
High Risk Diabetic Foot Ulcer (DFU)
Podimetrics smart map
Podimetrics SmartMat: Participants receive training for stepping on SmartMat each day for 6 months. Monthly phone calls will be conducted to assess foot health and mat.
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology
Baseline characteristics by cohort
| Measure |
High Risk Diabetic Foot Ulcer (DFU)
n=20 Participants
Podimetrics smart map
Podimetrics SmartMat: Participants receive training for stepping on SmartMat each day for 6 months. Monthly phone calls will be conducted to assess foot health and mat.
|
|---|---|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 8.0 • n=14 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=14 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: Up to six months following interventionParticipant adherence to use of SmartMat will be quantified by automated data collection. Adherence is defined as having conducted \>3 days foot scans per week (foot scans/week) over the six-month period. The median number of scans/week over a six-month period is reported.
Outcome measures
| Measure |
High Risk Diabetic Foot Ulcer (DFU)
n=19 Participants
Podimetrics smart map
Podimetrics SmartMat: Participants receive training for stepping on SmartMat each day for 6 months. Monthly phone calls will be conducted to assess foot health and mat.
|
|---|---|
|
Adherence to Use of SmartMat
|
6.4 number of foot scans/week
Interval 5.6 to 6.8
|
SECONDARY outcome
Timeframe: Up to six months following interventionUse of health care facilities will be enumerated based on the number of participants who presented for care over the course of the study. This will include patient visits to the Emergency Room (ER), podiatrist, internist, walk in clinic, and other health care facilities. This outcome will be based on participant self-reporting of visits. The total number of participants who visited a health care facility is summarized.
Outcome measures
| Measure |
High Risk Diabetic Foot Ulcer (DFU)
n=19 Participants
Podimetrics smart map
Podimetrics SmartMat: Participants receive training for stepping on SmartMat each day for 6 months. Monthly phone calls will be conducted to assess foot health and mat.
|
|---|---|
|
Use of Health Care Facilities
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to six months following interventionThe number of participants who developed DFU during the course of the study is summarized. Diagnosis of DFU was be based on a physical exam.
Outcome measures
| Measure |
High Risk Diabetic Foot Ulcer (DFU)
n=19 Participants
Podimetrics smart map
Podimetrics SmartMat: Participants receive training for stepping on SmartMat each day for 6 months. Monthly phone calls will be conducted to assess foot health and mat.
|
|---|---|
|
Occurrence of Diabetic Foot Ulcer (DFU)
|
5 Participants
|
POST_HOC outcome
Timeframe: Up to six months following interventionThe number of re-engagement calls per participant over the 6-month study period is summarized using basic descriptive statistics. Participants were called each month to determine if there was any diabetic foot ulcer development or utilization of health care facilities (corresponding study outcome measures). Increases in foot temperature (i.e., increase in 2.2 degrees Celsius over two consecutive uses between and of six contralaterally sites), a marker for early ulcer, also triggered a call to the study participant.
Outcome measures
| Measure |
High Risk Diabetic Foot Ulcer (DFU)
n=19 Participants
Podimetrics smart map
Podimetrics SmartMat: Participants receive training for stepping on SmartMat each day for 6 months. Monthly phone calls will be conducted to assess foot health and mat.
|
|---|---|
|
The Number of Re-engagement Calls Per Participant Over the 6-month Study Period
|
2 calls per participant
Interval 0.0 to 3.0
|
Adverse Events
High Risk Diabetic Foot Ulcer (DFU)
Serious adverse events
| Measure |
High Risk Diabetic Foot Ulcer (DFU)
n=20 participants at risk
Podimetrics smart map
Podimetrics SmartMat: Participants receive training for stepping on SmartMat each day for 6 months. Monthly phone calls will be conducted to assess foot health and mat.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Hospitalization
|
5.0%
1/20 • Number of events 1 • Approximately six months
|
|
General disorders
Hospitalization
|
25.0%
5/20 • Number of events 5 • Approximately six months
|
Other adverse events
| Measure |
High Risk Diabetic Foot Ulcer (DFU)
n=20 participants at risk
Podimetrics smart map
Podimetrics SmartMat: Participants receive training for stepping on SmartMat each day for 6 months. Monthly phone calls will be conducted to assess foot health and mat.
|
|---|---|
|
Infections and infestations
Increased Foot Temperature
|
60.0%
12/20 • Number of events 14 • Approximately six months
|
|
Skin and subcutaneous tissue disorders
Diabetic Foot Ulcer
|
25.0%
5/20 • Number of events 5 • Approximately six months
|
|
Skin and subcutaneous tissue disorders
Pre-ulcerative hyperkeratosis
|
5.0%
1/20 • Number of events 1 • Approximately six months
|
|
Infections and infestations
Osteomyelitis
|
5.0%
1/20 • Number of events 1 • Approximately six months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place