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.

Recruitment status

COMPLETED

Study phase

Target enrollment

116 participants

Primary outcome timeframe

up to 365 days

Results posted on

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

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

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=99 Participants	—	69 years n=206 Participants
Sex: Female, Male Female	38 Participants n=99 Participants	0 Participants n=107 Participants	38 Participants n=206 Participants
Sex: Female, Male Male	75 Participants n=99 Participants	0 Participants n=107 Participants	75 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=99 Participants	0 Participants n=107 Participants	20 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	91 Participants n=99 Participants	0 Participants n=107 Participants	91 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Asian	5 Participants n=99 Participants	0 Participants n=107 Participants	5 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Black or African American	12 Participants n=99 Participants	0 Participants n=107 Participants	12 Participants n=206 Participants
Race (NIH/OMB) White	73 Participants n=99 Participants	0 Participants n=107 Participants	73 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	19 Participants n=99 Participants	0 Participants n=107 Participants	19 Participants n=206 Participants

PRIMARY outcome

Timeframe: up to 365 days

Population: 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

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 days

Population: 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

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 days

Population: 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

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 days

Population: 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

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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Standard Care

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

Misty Humphries

UNIVERSITY OF CALIFORNIA DAVIS

Phone: 9167342028

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place