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OpenTrials
Completed

NCT Number: NCT04440839

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Foot Infection Diabetic Foot Ulcer Diabetic Neuropathies Diabetic Peripheral Neuropathy Endocrine System Diseases Foot Ulcer Leg Ulcer Peripheral Artery Disease Peripheral Vascular Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Misty D. Humphries

Sacramento, California, 95811, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemedicine specialty consultation

Other

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

Primary outcomes

  1. Specialty Consultation

    Time frame: up to 365 days

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

Secondary outcomes

  1. Revascularization

    Time frame: 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. Wound Healing

    Time frame: up to 365 days

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

  3. Amputation

    Time frame: up to 365 days

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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 22, 2020
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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