Trial Outcomes & Findings for In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers (NCT NCT02647346)
NCT ID: NCT02647346
Last Updated: 2020-02-21
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
132 participants
Primary outcome timeframe
Through study completion or subject withdrawal (34 weeks per-protocol)
Results posted on
2020-02-21
Participant Flow
Participant milestones
| Measure |
Participant Cohort
Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment.
|
|---|---|
|
Overall Study
STARTED
|
132
|
|
Overall Study
COMPLETED
|
129
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers
Baseline characteristics by cohort
| Measure |
Participant Cohort
n=129 Participants
Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
74 Participants
n=5 Participants
|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Racial Origin · African American
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Racial Origin · American Indian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Racial Origin · Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Racial Origin · Caucasian
|
76 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Racial Origin · Hispanic/Latino
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Racial Origin · Native American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Racial Origin · Unspecified
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
129 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion or subject withdrawal (34 weeks per-protocol)Outcome measures
| Measure |
Participant Cohort
n=129 Participants
Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment.
|
|---|---|
|
Occurrence of Plantar Diabetic Foot Ulcer
|
37 Participants
|
SECONDARY outcome
Timeframe: Through study completion or subject withdrawal (34 weeks per-protocol)Outcome measures
| Measure |
Participant Cohort
n=129 Participants
Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment.
|
|---|---|
|
Subject Adherence in Daily Use of the Study Device
|
5.5 uses/week
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Through study completion or subject withdrawal (34 weeks per-protocol)Outcome measures
| Measure |
Participant Cohort
n=132 Participants
Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment.
|
|---|---|
|
Device-related Trips/Falls
|
0 occurence
|
SECONDARY outcome
Timeframe: Through study completion or subject withdrawal (34 weeks per-protocol)Outcome measures
| Measure |
Participant Cohort
n=132 Participants
Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment.
|
|---|---|
|
Device-related Injuries
|
0 occurence
|
Adverse Events
Participant Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 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