Implementation of Telemedicine for Patient With Lower Extremity Wounds

Sponsor
University of California, Davis (Other)
Overall Status
Recruiting
CT.gov ID
NCT04440839
Collaborator
(none)
125
1
2
46.9
2.7

Study Details

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
125 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
Implementation of Telemedicine for Patient With Lower Extremity Wounds
Actual Study Start Date :
Feb 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. Wound healing [up to 365 days]

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

  5. Amputation [up to 365 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Misty D. Humphries Sacramento California United States 95811

Sponsors and Collaborators

  • University of California, Davis

Investigators

  • Principal Investigator: Misty D Humphries, University of California, Davis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT04440839
Other Study ID Numbers:
  • 1598596
First Posted:
Jun 22, 2020
Last Update Posted:
Mar 7, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 7, 2022