Diabetic Foot Ulcer and Wound Infection

The University of Texas System (UT)

Status: Withdrawn

Conditions: Diabetes; Diabetes Complications; Diabetic Foot Ulcer; Wound Infection

Treatments: Device: Telcare 2.0 BGM

Study type: Observational

Funder types: Other

Identifiers

NCT03827902

STU 042018-008

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

Intervention Group

Description:

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.

Treatment:

Device: Telcare 2.0 BGM

Control Group

Description:

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.