Implementation of Telemedicine for Patient With Lower Extremity Wounds

Peripheral Arterial Disease Clinical Trial

Official title:

Implementation of Telemedicine for Patient With Lower Extremity Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04440839
• Other study ID #: 1598596
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: December 31, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Infection
• Diabetic Foot Ulcer
• Diabetic Peripheral Neuropathy
• Foot Ulcer
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Peripheral Nervous System Diseases
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Other:
• Telemedicine 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

Locations

Country	Name	City	State
United States	Misty D. Humphries	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specialty Consultation	The time from the date the wound is identified to the date of specialist consultation, in days.	up to 365 days
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.	up to 365 days
Secondary	Hospitalizations	Number of hospitalizations for the index leg and wound, from the time the wound is identified to the time the wound heals.	up to 365 days
Secondary	Emergency room visits	The number of emergency room visits for the wound or the index leg, from the time the wound was identified to the time the wound heals.	up to 365 days
Secondary	Wound healing	The time from when the wound is identified until the wound heals, in days.	up to 365 days
Secondary	Amputation	Major (above the ankle) or minor (toe/TMA) amputation of the index leg.	up to 365 days