Diabetic Foot Ulcer and Wound Infection

Withdrawn

• Conditions: Diabetes Complications; Diabetes; Diabetic Foot Ulcer; Wound Infection
• Interventions: Device: Telcare 2.0 BGM

• Registration Number: NCT03827902
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-02-04
• Study Start: 2019-07-09
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-02
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention Group	Telcare 2.0 BGM	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.

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	6 months	Mean change in HbA1c from baseline to end of treatment

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with emergency department visits	6 months	Proportion of patients with emergency department visits following enrollment
Cost of glycemic management during study	6 months	• 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
Glycemic control	6 months	Proportion of patients with lower A1C and insulin use
Foot ulcer and/or wound healing	6 months	Complete wound healing as defined by University of Texas Health System
Patient reported satisfaction with diabetes treatment	6 months	Self-reported outcome assessment questionnaire using the Diabetes Treatment Satisfcation Questionnaire (DTSQ) \[Scale range 0-48\]; lower scores represent worse outcomes
Patient reported health status	6 months	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
Proportion of days covered score	6 months	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)
Proportion of patients with hospitalization	6 months	Proportion of patients with hospitalization following enrollment
Frequency of invasive procedures	6 months	Total number and type of invasive procedures related to diabetic foot ulcer and or wound infection
Number of outpatient visits	6 months	Total number of outpatient visits for general or specialized care (including virtual visits) during trial
Number of casts and boots used for treatment	6 months	Total number of casts and boots used for treatment related to diabetic foot ulcer and or wound infection
Overall hospital incurred patient-specific cost	6 months	Cost (in US $) of overall patient care for Parkland during study enrollment

Trial Locations

Locations (1)

Parkland Health and Hospital System; 🇺🇸 Dallas, Texas, United States