Diabetic Foot Ulcer and Wound Infection

Remote Glycemic Management for Patients With Diabetic Foot Ulcer and Wound Infection

The goal of the study is to compare whether an integrated model of care between Foot Wound and Diabetes Clinic with use of remote glucose monitoring technology (Intervention Arm), as compared with usual care without the use of remote glucose monitoring technology (Control Arm), will result in 1) improved glycemic control, 2) improved ulcer and wound healing, 3) improved patient reported outcomes (PROs), 4) reduced long-term healthcare resource utilization, and 5) improved adherence to anti-glycemic therapy for patients with DFUWI and poor glycemic control over the course of a 6-month intervention period.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes; Diabetes Complications; Wound Infection; Diabetic Foot Ulcer
• Intervention / Treatment: Device: Telcare 2.0 BGM

Detailed Description

This is a two-arm non-randomized convenient pilot trial to assess impact of an active glycemic management model through remote glucose monitoring technology amongst patients with DFUWI and poor glycemic control at the Parkland Diabetes Foot & Wound clinic. The plan is to implement a remote glucose monitoring technology to facilitate improved glycemic management and control. A cellular enabled glucose meter that will upload blood glucose measurements to a cloud server accessible by providers who can remotely review glycemic trends and remotely provide patients with proactive recommendations for treatment adjustments will be used. Patients receiving services in the integrated care model (same day visits in the Foot Wound and Diabetes Clinics at Parkland) will be eligible for inclusion in the intervention arm which includes proactive glucose monitoring guided by remote glucose monitoring technology. Patients receiving usual care services (non-integrated care model clinic days where Foot Wound and Diabetes Clinic visits are on separate days) will be eligible for inclusion in the control arm. The expectation is that patients in the intervention arm will experience greater improvements in glycemic control, compared to the usual care model. The hypothesis is that improved glycemic control in these patients will result in faster healing of diabetic foot wound, infections or ulcers. The effectiveness of the technologically facilitated integrated model of care will be evaluated compared to the usual care using metrics for diabetic foot ulcers and wound healing, glycemic control, patient reported outcomes, health resource utilization and medication adherence after 6 months of intervention. The Telcare 2.0 BGM for remote self-blood glucose monitoring(FDA Cleared) will be used.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Parkland Health and Hospital System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with diabetic foot ulcer &/or wound infection and poor glycemic control (A1C ≥ 8.5%) seen in the Foot Wound clinic at a public hospital.

Description

Inclusion Criteria:

• Type 2 Diabetes
• 18 years and older
• A1C greater than or equal to 8.5% within the preceding 6 months
• A1C greater than 8% on day of enrollment
• Active diabetic foot ulcer or wound receiving treatment in the Foot Wound clinic at Parkland (ulcer that meets University of Texas Classification Grade 1 or 2 of any stage)

Exclusion Criteria:

• Chronic osteomyelitis (even if completed active therapy)
• Moderate/severe lower limb infection (per Infectious Diseases Society of America criteria)
• Diabetic Foot Ulcer and Wound Infection on Charcot Foot
• Any serious/unstable medical condition that interferes with treatment assignment
• Ankle Brachial Index less than 0.7 or toe pressures less than 30mmHg
• Unwilling to participate or receive injectable treatment or unable to keep appointments
• Non-English or Non-Spanish speakers
• Pregnant or planning to become pregnant

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention Group; A Telcare 2.0 BGM, which is FDA cleared, will be used to upload blood glucose measurements to a cloud server accessible by providers. Intervention group will participate in an integrated care model where they will attend Diabetic Clinic and Foot Wound appointments on the same day.	Device: Telcare 2.0 BGM; Blood glucose meter that uploads blood glucose measurements to a cloud server that providers can access and use to monitor patients' glycemic trends.
Control Group; Control Group will receive usual care (a non-integrated care model where Diabetes Clinic and Foot Wound appointments are on separate days.) These patients will not receive a blood monitoring glucose device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c	Mean change in HbA1c from baseline to end of treatment	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic control	Proportion of patients with lower A1C and insulin use	6 months
Foot ulcer and/or wound healing	Complete wound healing as defined by University of Texas Health System	6 months
Patient reported satisfaction with diabetes treatment	Self-reported outcome assessment questionnaire using the Diabetes Treatment Satisfcation Questionnaire (DTSQ) [Scale range 0-48]; lower scores represent worse outcomes	6 months
Patient reported health status	Self-reported outcome assessment questionnaires using the 5 level EQ-5D health status measure (EQ-5D-5L) [Scale range 5-25]; higher scores represent worse outcome	6 months
Proportion of patients with emergency department visits	Proportion of patients with emergency department visits following enrollment	6 months
Proportion of days covered score	Proportion of days covered score represents an indirect measure of medication adherence and represents the proportion of days medication was dispensed (numerator) over the total potential days the medication should have been dispensed (denominator)	6 months
Proportion of patients with hospitalization	Proportion of patients with hospitalization following enrollment	6 months
Frequency of invasive procedures	Total number and type of invasive procedures related to diabetic foot ulcer and or wound infection	6 months
Number of outpatient visits	Total number of outpatient visits for general or specialized care (including virtual visits) during trial	6 months
Number of casts and boots used for treatment	Total number of casts and boots used for treatment related to diabetic foot ulcer and or wound infection	6 months
Overall hospital incurred patient-specific cost	Cost (in US $) of overall patient care for Parkland during study enrollment	6 months
Cost of glycemic management during study	• Cost of glycemic management during trial, including cost of encounters (including telephone and virtual visits), testing supplies, drug costs, technology costs specifically related to glycemic management	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of hypoglycemic events	Comparison of frequency of severe hypoglycemic symptoms for usual care versus intervention arm	6 months

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Parkland Health and Hospital System
• Investigators: Principal Investigator: Uma Gunasekaran, MD, University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 9, 2019
• Primary Completion (ACTUAL): April 1, 2020
• Study Completion (ACTUAL): April 2, 2020

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (ACTUAL): February 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 6, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Skin Diseases; Endocrine System Diseases; Disease Attributes; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetic Neuropathies; Foot Diseases; Diabetes Mellitus; Diabetic Foot; Foot Ulcer; Ulcer; Infections; Communicable Diseases; Wounds and Injuries; Wound Infection; Diabetes Complications
• Other Study ID Numbers: STU 042018-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No