Diabetic Foot Ulcer and Wound Infection

Withdrawn before enrolling

Conditions studied: Diabetes Complications, Diabetes, Diabetic Foot Ulcer, Wound Infection

In brief

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.

Key facts

Study ID

NCT03827902

Run by

University of Texas Southwestern Medical Center

People needed

0

Starts

2019-07-09

Expected to finish

2020-04-02

Last updated by the study team

2020-11-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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