Diabetic Foot, Diabetic Foot Infection, Diabetic Foot Ulcer, Diabetic Peripheral Neuropathy, Peripheral Arterial Disease, Peripheral Artery Disease, Peripheral Vascular Diseases
Conditions
Brief summary
The objective of this study is to determine if patients with lower extremity wounds in rural communities who undergo specialty referral through telemedicine have expedited care compared to patients who are treated through standard in person referral.
Detailed description
This is a clustered trial where patients identified as having lower extremity ulcers with peripheral artery disease and diabetes are given the option to be seen by specialty care providers through telemedicine vs. normal standard in person referral. The study is being conducted in rural areas where there are no in person vascular surgery providers. The aim of the study is to determine if patient activation affects likelihood to use telemedicine and if use of telemedicine can expedite speciality care.
Interventions
OTHERTelemedicine specialty consultation
Patients with lower extremity wounds due to peripheral artery disease and diabetes mellitus will undergo a specialty consultation with a provider through telemedicine
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of California, Davis
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients identified as having a lower extremity wound with peripheral artery disease or diabetes mellitus are offered a telemedicine consult. Patients are then followed for time to consultation, time to revascularization if needed, and time to wound healing.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with the diagnosis of a lower extremity ulcer that has been present for longer than 2 weeks * Must be willing to complete the patient activation survey * Must be willing to have the study personnel call them to check in on their status
Exclusion criteria
* Patients that do not have a telephone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Specialty Consultation | up to 365 days | The time from the date the wound is identified to the date of specialist consultation, in days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Revascularization | up to 365 days | The time from the date the wound is identified to the procedure to evaluation or improve blood flow for the index leg, in days. |
| Wound Healing | up to 365 days | The time from when the wound is identified until the wound heals, in days. |
| Amputation | up to 365 days | Major (above the ankle) or minor (toe/TMA) amputation of the index leg. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from two clinical sites where wound care was provided. One site had access to revascularization services and the other did not.
Pre-assignment details
All subjected had to have a wound on the foot.
Participants by arm
| Arm | Count |
|---|---|
| Telemedicine 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. | 113 |
| Standard Care Patent who received wound care without telemedicine | 0 |
| Total | 113 |
Baseline characteristics
| Characteristic | Total | Telemedicine | Standard Care |
|---|---|---|---|
| Age, Continuous | 69 years | 69 years | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 20 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 91 Participants | 91 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 5 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 12 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants | 19 Participants | 0 Participants |
| Race (NIH/OMB) White | 73 Participants | 73 Participants | 0 Participants |
| Sex: Female, Male Female | 38 Participants | 38 Participants | 0 Participants |
| Sex: Female, Male Male | 75 Participants | 75 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 113 | 0 / 0 |
| other Total, other adverse events | 0 / 113 | 0 / 0 |
| serious Total, serious adverse events | 0 / 113 | 0 / 0 |
Outcome results
Primary
Specialty Consultation
The time from the date the wound is identified to the date of specialist consultation, in days.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Specialty Consultation | 66 days |
Secondary
Amputation
Major (above the ankle) or minor (toe/TMA) amputation of the index leg.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Amputation | minor amputation | 20 Participants |
| Intervention | Amputation | Major amputation | 5 Participants |
| Intervention | Amputation | No amputation | 83 Participants |
| Intervention | Amputation | Lost to follow up | 5 Participants |
Secondary
Revascularization
The time from the date the wound is identified to the procedure to evaluation or improve blood flow for the index leg, in days.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Revascularization | 71 days |
Secondary
Wound Healing
The time from when the wound is identified until the wound heals, in days.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Wound Healing | 174 days |