Clinical trial NCT03827902: Diabetic Foot Ulcer and Wound Infection
Official title: Remote Glycemic Management for Patients With Diabetic Foot Ulcer and Wound Infection
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetes Complications
Diabetes
Diabetic Foot Ulcer
Wound Infection
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Parkland Health and Hospital System
First posted: 2019-02-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c
timeFrame: 6 months
Secondary outcomes:
measure: Glycemic control
timeFrame: 6 months
measure: Foot ulcer and/or wound healing
timeFrame: 6 months
measure: Patient reported satisfaction with diabetes treatment
timeFrame: 6 months
measure: Patient reported health status
timeFrame: 6 months
measure: Proportion of patients with emergency department visits
timeFrame: 6 months
measure: Proportion of days covered score
timeFrame: 6 months
measure: Proportion of patients with hospitalization
timeFrame: 6 months
measure: Frequency of invasive procedures
timeFrame: 6 months
measure: Number of outpatient visits
timeFrame: 6 months
measure: Number of casts and boots used for treatment
timeFrame: 6 months
measure: Overall hospital incurred patient-specific cost
timeFrame: 6 months
measure: Cost of glycemic management during study
timeFrame: 6 months
Other outcomes:
measure: Frequency of hypoglycemic events
timeFrame: 6 months
Locations:
city: Dallas
country: United States
facility: Parkland Health and Hospital System
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Uma Gunasekaran, MD
role: PRINCIPAL_INVESTIGATOR
References: