Implementation of Telemedicine for Patient With Lower Extremity Wounds
Phase: NA
Conditions: Peripheral Arterial Disease, Peripheral Artery Disease, Peripheral Vascular Diseases, Diabetic Foot, Diabetic Foot Ulcer, Diabetic Foot Infection, Diabetic Peripheral Neuropathy
Sponsor: University of California, Davis

PROTOCOL TITLE: Implementation of Telemedicine for patients with wounds 
and ulcers.   
 
Page 1 of 5 
 
 
 
 
 
1) Protocol Title  
Title: Implementation of Telemedicine for patients with wounds and ulcers.   
 
Protocol Version Date: March 11th, 2021 
2) Objectives:  
The objective of this quality improvement project is to assess if telemedicine can 
improve the quality of specialty care offered for new patients with wounds and 
ulcers due to peripheral artery disease (PAD) and diabetes mellitus (DM) at 
RHCs.  The specific aims of this project are: 
a) Implement telemedicine consultations at rural health clinics.  
b) Evaluate the effect of telemedicine consultation to improve time to 
specialist evaluation and time to definitive treatment for patients 
with wounds and ulcers in rural clinics.  
c) To determine if patients with lower levels of activation need more 
resources to help get care when offered telemedicine 
Hypothesis:  Telemedicine consultation can decrease mean time to specialist 
consultation and time to definitive vascular treatment by 50%. Use of telemedicine 
will be able to overcome low levels of patient activation by allowing patients to get 
care in their home area.   
 
3) Background 
Each year, more than 185,000 patients with PAD, DM, or combined PAD/DM 
undergo leg amputation. Costs to treat wounds and ulcers currently approach 
$25 billion annually and are expected to double in the next decade.1,2 When ulcer 
treatment is not effective, amputation is the outcome and currently, 1.4 million 
people live with an amputation in the United States.3,4 Predictors of higher 
amputation rates include worse ankle-brachial index,5 African-American race6, 
lower socio-economic status, dialysis dependence, and older age.7–10 Patients 
living in rural areas are 51% more likely to undergo amputation than those in 
urban areas.11,12 
Patients residing in rural areas face numerous barriers to care. Their concerns are 
poorly understood, however, these patients are typically of lower socioeconomic 
status and have limited knowledge of chronic diseases which results in lower 
patient activation. The distance and burden of coordinating travel, time off work, 
and need to attend multiple clinic visits can be impossible for patients and 
families. The hardships patients endure in an effort to attend remote appointments 
results in unrealistic patient expectations, physician dissatisfaction, non-
compliance with treatment, increased hospitalizations, and lower patient activation 
in disease management. 
 
In February 2016 focused guidelines for assessment of ulcers were published as 
a joint effort by the Society for Vascular Surgery, American Podiatric Medical 
Society, and Society of Vascular Medicine. Implementation of these guidelines 

PROTOCOL TITLE: Implementation of Telemedicine for patients with wounds 
and ulcers.   
 
Page 2 of 5 
 
 
 
 
 
has been poor, especially in rural areas. Telemedicine improves access to expert 
specialty consultation and patient-centered care in the ambulatory settings. 
Implementation of telemedicine combines involved faculty with a team-building 
mentality, concise web-based tools for incorporation into daily practice, and 
specialty consultation. Telemedicine has been effective in psychiatry, pediatrics, 
dermatology, and cardiovascular diseases. In telemedicine wound programs for 
the treatment of ulcers in other countries, physicians found images at remote 
consultation showed a high concordance compared to in-person evaluation and 
providers were successful at making wound care recommendations based on 
images.  
 
The NHLBI strategic vision prioritized community-based effectiveness and 
implementation research strategies to address health inequalities. Multiple 
countries have implemented telemedicine wound care programs to improve cost 
effectiveness of treatment. These programs decreased costs for transportation to 
provide wound care by 46%. Extrapolation to US wound care costs could indicate 
a potential savings of nearly $15 billion annually by implementing a national 
telemedicine treatment program for ulcer management.  
 
The Vascular Clinic at UC Davis currently conducts telehealth medical visits as a 
part of the general referall program at UC Davis Health. Within this referall 
program the clinic works with several Rural Health Centers (RHC) in California 
and utlilizes telehealth medicine as a part of the referral process. This research 
study proposes to examine the information that is collected during these visits the 
primary endpoint for this study is time to specialty consultation 
 
4) Inclusion and Exclusion Criteria 
Patients will be identified by the clinic when they come in for their regular 
visit.  
Inclusion Criteria 
1. 18 years or older  
2. Have a wound or ulcer for more than two weeks. 
3. Have a diagnosis of Diabetes Mellitus (DM), Peripheral Artery 
Disease (PAD), vascular disease, or combined PAD/DM 
4. Willing to see a provider by telemedicine 
5. Able to complete the Patient Activation Measurement (PAM) survey 
6. Willing to be contacted by research team 
 
Exclusion Criteria 
1. Patients who do not want to participate in the telemedicine visit 
2. Adults unable to read and write English. The PAM study is 
only in English at this time 
3. Patients that do not have a home phone or home internet. This is 
needed to do follow up and any follow up telemedicine visits 
4. Patients that do not have a smart phone or computer that can 
connect to the internet 
 

PROTOCOL TITLE: Implementation of Telemedicine for patients with wounds 
and ulcers.   
 
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We do not plan to include:  
• Pregnant women- low incidence of wounds in these patients 
due to PAD and DM 
• Prisoners- Cannot accurately determine care and outcomes 
Number of Subjects:  
Rural Health Clinic A 
25 
Rural Health Clinic B 
25 
Rural Health Clinic C 
25 
Rural Health Clinic D 
25 
Rural Health Clinic E 
25 
Total Number of Patients 
125 
 
We plan to include 25 subjects at each of the 5 out of network clinics that 
are referred to the UC Davis Vascular Clinic for telehealth services for a 
total enrollment of 125 patients.  
5) Study Timelines 
The Screening and follow up of data of all patients will start approximately 
from 5/01/2020 – and end 12/31/2021 
 
Review and Analysis should will be completed by approximately 06/30/2022 
 
6) Study Endpoints 
The primary endpoint for this study is time to specialty consultation.  
Secondary endpoints are time to revascularization, time to other 
specialty consultation, time to wound healing, number of 
telemedicine visits, major amputation, number of hospitalizations, 
number of emergency room visits, and number of in person visits.  
 
 
 
 
 

PROTOCOL TITLE: Implementation of Telemedicine for patients with wounds 
and ulcers.   
 
Page 4 of 5 
 
 
 
 
 
7) Procedures Involved 
 
Screening: Patients referred from rural clinics will be screened when they 
are referred to the UC Davis Vascular Clinic for telehealth services  to 
determine if they meet the inclusion/exclusion criteria.   
 
Enrollment/Procedures at Baseline Telehealth Visit: Patients receiving 
telehealth services will follow the standard operating procedures for those 
visits. Which incudes asking new patients to to complete the UCD Privacy 
statement for new patients and a patient activation questionnaire on the day 
of their telemedicine visit. 
 
Follow-Up Post Teleheath Visit: All patients will be contacted every 4 
weeks to determine if they have had a procedure for their leg wound 
(revascularization) and if the wound has healed. Patients will be followed 
until they reach a secondary study end-point which is wound healing, 
amputation, or for a maximum of 12 months.  
 
8) Withdrawal of Subjects 
Patients who choose not to participate in completing a patient activitation 
questionnaire will not be included in this QI project. Patient care is not 
directed in this project and is clinical driven per standard of care and 
standard operating procedureds for the Vascular Clinic. 
 
9) Risks to Subjects 
This is a minimal risk study and the only risk forseen is a potential 
breach of confidentiality which will me minimized by securing the 
data as outlined in the protocol. 
10) Potential Benefits to Subjects 
No direct benefits to the patient will occur during the data collection and 
review of the QI project. Future patients may receive a benefit from 
increased access to telehealth visits or proven to shorten time to care for 
patients referred from rural cinics. 
 
 
 
 
 
 

PROTOCOL TITLE: Implementation of Telemedicine for patients with wounds 
and ulcers.   
 
Page 5 of 5 
 
 
 
 
 
Statistical Analysis Plan: Changed as a result of COVID and removal of the comparison arm 
of the study 
 
 The data will be analyzed by Kaplan-Meier analysis comparing time to specialty visit for patients 
who underwent telemedicine visits to those who did not. Secondary outcome analysis will include 
chi-squared analysis of the proportion of patients that had wound healing in the telemedicine 
group compared to those that did not have a telemedicine visit, and Kaplan-Meier analysis of 
time to definitive revascularization and wound healing for patients that underwent telemedicine 
and were treated at UCD.  
 
Assuming a historical median time to a specialist consultation of 9 weeks, we will utilize a one-
sample log-rank test. We want a sample large enough to detect a hazard ratio (HR) of 3.0 or 
higher. An HR of 3.0 indicates that at any time, three times as many specialists will consult many 
patients with telemedicine consultations compared to in-person consultations. A two-sided, one-
sample log-rank test calculated from a sample of 24 individuals achieves 89.2% power at a 0.05 
significance level to detect a hazard ratio of 3.0 when the median time to consultation of the 
historical control group is 9 weeks. The probability that a patient experienced a specialist 
consultation during the study is 0.44. The expected number of events during the study is 11. The 
time to specialist consultation is likely distributed by the Weibull distribution (shape parameter 
1) by both groups (telemedicine and historical controls).