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Implementation of Telemedicine for Patient With Lower Extremity Wounds

Primary Purpose

Peripheral Arterial Disease, Peripheral Artery Disease, Peripheral Vascular Diseases

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Telemedicine specialty consultation

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Misty D. HumphriesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Standard Care

Arm Description

Telemedicine specialty consultation for patients

Standard in person referral to a specialist

Outcomes

Primary Outcome Measures

Specialty Consultation

The time from the date the wound is identified to the date of specialist consultation, in days.

Secondary Outcome Measures

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.

Hospitalizations

Number of hospitalizations for the index leg and wound, from the time the wound is identified to the time the wound heals.

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.

Wound healing

The time from when the wound is identified until the wound heals, in days.

Amputation

Major (above the ankle) or minor (toe/TMA) amputation of the index leg.

Full Information

NCT ID

NCT04440839

First Posted

June 11, 2020

Last Updated

January 27, 2023

Sponsor

University of California, Davis

1. Study Identification

Unique Protocol Identification Number

NCT04440839

Brief Title

Implementation of Telemedicine for Patient With Lower Extremity Wounds

Official Title

Implementation of Telemedicine for Patient With Lower Extremity Wounds

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2020 (Actual)

Primary Completion Date

November 1, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Telemedicine specialty consultation for patients

Arm Title

Standard Care

Arm Type

No Intervention

Arm Description

Standard in person referral to a specialist

Intervention Type

Other

Intervention Name(s)

Telemedicine specialty consultation

Intervention Description

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

Primary Outcome Measure Information:

Title

Specialty Consultation

Description

The time from the date the wound is identified to the date of specialist consultation, in days.

Time Frame

up to 365 days

Secondary Outcome Measure Information:

Title

Revascularization

Description

The time from the date the wound is identified to the procedure to evaluation or improve blood flow for the index leg, in days.

Time Frame

up to 365 days

Title

Hospitalizations

Description

Number of hospitalizations for the index leg and wound, from the time the wound is identified to the time the wound heals.

Time Frame

up to 365 days

Title

Emergency room visits

Description

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.

Time Frame

up to 365 days

Title

Wound healing

Description

The time from when the wound is identified until the wound heals, in days.

Time Frame

up to 365 days

Title

Amputation

Description

Major (above the ankle) or minor (toe/TMA) amputation of the index leg.

Time Frame

up to 365 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Misty Humphries

Phone

9167342028

mdhumphries@ucdavis.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Cameron Ylagan

cvylagan@ucdavis.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Misty D Humphries

Organizational Affiliation

University of California, Davis

Official's Role

Principal Investigator

Facility Information:

Facility Name

Misty D. Humphries

City

Sacramento

State/Province

California

ZIP/Postal Code

95811

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Misty D Humphries

Phone

916-712-7313

dzstorm.md@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Implementation of Telemedicine for Patient With Lower Extremity Wounds

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