Trial Outcomes & Findings for Implementation of Telemedicine for Patient With Lower Extremity Wounds (NCT NCT04440839)
NCT ID: NCT04440839
Last Updated: 2025-09-04
Results Overview
The time from the date the wound is identified to the date of specialist consultation, in days.
COMPLETED
NA
116 participants
up to 365 days
2025-09-04
Participant Flow
Subjects were recruited from two clinical sites where wound care was provided. One site had access to revascularization services and the other did not.
All subjected had to have a wound on the foot.
Participant milestones
| Measure |
Telemedicine
Participants received specialty wound care consultations through telemedicine.
|
Standard Care
Participants received usual wound care at their clinic without telemedicine consultation.
|
|---|---|---|
|
Overall Study
STARTED
|
116
|
0
|
|
Overall Study
COMPLETED
|
113
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Implementation of Telemedicine for Patient With Lower Extremity Wounds
Baseline characteristics by cohort
| Measure |
Telemedicine
n=113 Participants
Telemedicine specialty consultation for patients These subjects were all \>18 years old, of all races specifically with a focus on the native American population is the area of one clinic.
|
Standard Care
Patent who received wound care without telemedicine
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
—
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
91 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
73 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 365 daysPopulation: Due to COVID-19-related changes at the time the study was initiated, no subjects were enrolled in the standard car group.
The time from the date the wound is identified to the date of specialist consultation, in days.
Outcome measures
| Measure |
Intervention
n=113 Participants
Telemedicine specialty consultation for patients These subjects were all \>18 years old, of all races specifically with a focus on the native American population is the area of one clinic.
|
Standard Care
Subjects who received wound care without a telemedicine visit
NO subjects were enrolled in this group due to COVID restrictions and changes in subject participation
|
|---|---|---|
|
Specialty Consultation
|
66 days
Interval 33.0 to 139.0
|
—
|
SECONDARY outcome
Timeframe: up to 365 daysPopulation: Due to COVID-19-related changes at the time the study was initiated, no subjects were enrolled in the standard car group.
The time from the date the wound is identified to the procedure to evaluation or improve blood flow for the index leg, in days.
Outcome measures
| Measure |
Intervention
n=113 Participants
Telemedicine specialty consultation for patients These subjects were all \>18 years old, of all races specifically with a focus on the native American population is the area of one clinic.
|
Standard Care
Subjects who received wound care without a telemedicine visit
NO subjects were enrolled in this group due to COVID restrictions and changes in subject participation
|
|---|---|---|
|
Revascularization
|
71 days
Interval 16.0 to 245.0
|
—
|
SECONDARY outcome
Timeframe: up to 365 daysPopulation: Due to COVID-19-related changes at the time the study was initiated, no subjects were enrolled in the standard car group.
The time from when the wound is identified until the wound heals, in days.
Outcome measures
| Measure |
Intervention
n=113 Participants
Telemedicine specialty consultation for patients These subjects were all \>18 years old, of all races specifically with a focus on the native American population is the area of one clinic.
|
Standard Care
Subjects who received wound care without a telemedicine visit
NO subjects were enrolled in this group due to COVID restrictions and changes in subject participation
|
|---|---|---|
|
Wound Healing
|
174 days
Interval 76.0 to 402.0
|
—
|
SECONDARY outcome
Timeframe: up to 365 daysPopulation: Due to COVID-19-related changes at the time the study was initiated, no subjects were enrolled in the standard car group.
Major (above the ankle) or minor (toe/TMA) amputation of the index leg.
Outcome measures
| Measure |
Intervention
n=113 Participants
Telemedicine specialty consultation for patients These subjects were all \>18 years old, of all races specifically with a focus on the native American population is the area of one clinic.
|
Standard Care
Subjects who received wound care without a telemedicine visit
NO subjects were enrolled in this group due to COVID restrictions and changes in subject participation
|
|---|---|---|
|
Amputation
No amputation
|
83 Participants
|
—
|
|
Amputation
minor amputation
|
20 Participants
|
—
|
|
Amputation
Major amputation
|
5 Participants
|
—
|
|
Amputation
Lost to follow up
|
5 Participants
|
—
|
Adverse Events
Intervention
Standard Care
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