Implementation of Telemedicine for Patient With Lower Extremity Wounds

NCT ID: NCT04440839

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2023-12-31

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.

Conditions

Peripheral Arterial Disease; Peripheral Artery Disease; Peripheral Vascular Diseases; Diabetic Foot; Diabetic Foot Ulcer; Diabetic Foot Infection; Diabetic Peripheral Neuropathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Telemedicine specialty consultation for patients

Group Type: EXPERIMENTAL

Telemedicine specialty consultation

Intervention Type: OTHER

Patients with lower extremity wounds due to peripheral artery disease and diabetes mellitus will undergo a specialty consultation with a provider through telemedicine

Standard Care

Standard in person referral to a specialist

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Misty D Humphries

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

Misty D. Humphries

Sacramento, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5K23HL143178-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1598596

Identifier Type: -

Identifier Source: org_study_id