Implementation of Telemedicine for Patient With Lower Extremity Wounds

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot; Peripheral Arterial Disease; Peripheral Vascular Diseases; Diabetic Foot Ulcer; Diabetic Peripheral Neuropathy; Peripheral Artery Disease; Diabetic Foot Infection
• Intervention / Treatment: Other: Telemedicine specialty consultation

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 Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95811
      • Misty D. Humphries

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Telemedicine specialty consultation for patients	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
No Intervention: Standard Care; Standard in person referral to a specialist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specialty Consultation	The time from the date the wound is identified to the date of specialist consultation, in days.	up to 365 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Amputation	Major (above the ankle) or minor (toe/TMA) amputation of the index leg.	up to 365 days
Wound Healing	The time from when the wound is identified until the wound heals, in days.	up to 365 days

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Misty D Humphries, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Foot Ulcer; Skin and Connective Tissue Diseases; Diabetic Foot; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 1598596; 5K23HL143178-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No