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Diabetic Foot Ulcer and Wound Infection

NCT ID: NCT03827902

Last Updated: 2020-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-09

Study Completion Date

2020-04-02

Brief Summary

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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

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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.

Conditions

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Diabetes Complications Diabetes Diabetic Foot Ulcer Wound Infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Telcare 2.0 BGM

Intervention Type DEVICE

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.

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Parkland Health and Hospital System

OTHER

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Uma Gunasekaran

Assistant Professor, Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Uma Gunasekaran, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

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Parkland Health and Hospital System

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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STU 042018-008

Identifier Type: -

Identifier Source: org_study_id