Implementation of Telemedicine for Patient With Lower Extremity Wounds

NCT04440839 | Completed Results

• 2 other identifiers: 15985965K23HL143178-05
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Specialty Consultation

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

  up to 365 days

Secondary Outcomes (3)

• Revascularization

  up to 365 days

• Wound Healing

  up to 365 days

• Amputation

  up to 365 days

Study Arms (2)

Intervention

EXPERIMENTAL

Telemedicine specialty consultation for patients

Other: Telemedicine specialty consultation

Standard Care

NO INTERVENTION

Standard in person referral to a specialist

Interventions

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients that do not have a telephone

Sponsors & Collaborators

• University of California, Davis: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Misty D. Humphries

Sacramento, California, 95811, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases; Diabetic Foot

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetic Angiopathies; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Limitations and Caveats

A significant limitation was the absence of a comparator group for subjects at the most remote telemedicine clinic. However, we were able to enroll subjects and provide them with improved care in the intervention group.

Results Point of Contact

• Title: Misty Humphries
• Organization: UNIVERSITY OF CALIFORNIA DAVIS

mdhumphries@health.ucdavis.edu

9167342028

Study Officials

• Misty D Humphries

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 22, 2020
• Study Start: March 1, 2020
• Primary Completion: November 1, 2023
• Study Completion: December 31, 2023
• Last Updated: September 4, 2025
• Results First Posted: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)