Peripheral Arterial DiseaseNCT04440839
Implementation of Telemedicine for Patient With Lower Extremity Wounds
A study testing Telemedicine specialty consultation in people with Peripheral Arterial Disease and Peripheral Artery Disease, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Peripheral Artery Disease, Peripheral Vascular Diseases
- What is being tested?
- Telemedicine specialty consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients that do not have a telephone
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Peripheral Arterial Disease, Peripheral Artery Disease, Peripheral Vascular Diseases, Diabetic Foot, Diabetic Foot Ulcer, Diabetic Foot Infection
- Being tested
- Telemedicine specialty consultation
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine specialty consultationOther
Patients with lower extremity wounds due to peripheral artery disease and diabetes mellitus will undergo a specialty consultation with a provider through telemedicine
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Telemedicine specialty consultation for patients Receives: Other: Telemedicine specialty consultation |
| Standard Care | No intervention | Standard in person referral to a specialist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specialty Consultation
The time from the date the wound is identified to the date of specialist consultation, in days.
Measured: up to 365 days
Secondary outcomes (3)
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.
Measured: up to 365 days
Wound Healing
The time from when the wound is identified until the wound heals, in days.
Measured: up to 365 days
Amputation
Major (above the ankle) or minor (toe/TMA) amputation of the index leg.
Measured: up to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Mar 2020
- Primary completion1 Nov 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Misty D Humphries, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440839
- Sponsor's protocol ID
- 1598596
- Other IDs
- 5K23HL143178-05
- Status last verified
- Aug 2025
- First submitted
- 11 Jun 2020
- Last updated
- 4 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Telemedicine for Patient With Lower Extremity Wounds
- ClinicalTrials.gov ID
- NCT04440839
- Acronym / sponsor ID
- 1598596
- Conditions
- Peripheral Arterial Disease, Peripheral Artery Disease, Peripheral Vascular Diseases, Diabetic Foot, Diabetic Foot Ulcer, Diabetic Foot Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Posted 4 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Telemedicine specialty consultationTelemedicine specialty consultation for patients |
| Standard Care | No intervention | –Standard in person referral to a specialist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients that do not have a telephone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine specialty consultationPatients with lower extremity wounds due to peripheral artery disease and diabetes mellitus will undergo a specialty consultation with a provider through telemedicine | Other | Intervention |
Primary outcome
Specialty Consultation
Time frame: up to 365 days
The time from the date the wound is identified to the date of specialist consultation, in days.
3 secondary outcomes
Revascularization
Time frame: up to 365 days
Wound Healing
Time frame: up to 365 days
Amputation
Time frame: up to 365 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Misty D Humphries principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine specialty consultation in people with Peripheral Arterial Disease and Peripheral Artery Disease, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specialty Consultation (time frame: up to 365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.