Implementation of Telemedicine for Patient With Lower Extremity Wounds

Not Applicable

Completed

• Conditions: Diabetic Foot Ulcer; Diabetic Foot; Diabetic Foot Infection; Peripheral Artery Disease; Peripheral Vascular Diseases; Peripheral Arterial Disease; Diabetic Peripheral Neuropathy
• Interventions: Other: Telemedicine specialty consultation

• Registration Number: NCT04440839
• Lead Sponsor: University of California, Davis

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.

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-06-11
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-22
• Status Verified: 2023-01
• Primary Completion: 2023-11-01
• Study Completion: 2023-12-31
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Telemedicine specialty consultation	Telemedicine specialty consultation for patients

Primary Outcome Measures

Name	Time	Method
Specialty Consultation	up to 365 days	The time from the date the wound is identified to the date of specialist consultation, in days.

Secondary Outcome Measures

Name	Time	Method
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.
Emergency room visits	up to 365 days	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.
Amputation	up to 365 days	Major (above the ankle) or minor (toe/TMA) amputation of the index leg.
Hospitalizations	up to 365 days	Number of hospitalizations for the index leg and wound, from the time the wound is identified to the time the wound heals.
Wound healing	up to 365 days	The time from when the wound is identified until the wound heals, in days.

Trial Locations

Locations (1)

Misty D. Humphries; 🇺🇸 Sacramento, California, United States