Diabetic Foot Ulcer and Wound Infection

NCT03827902 | Withdrawn

• 1 other identifier: STU 042018-008
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Complications; Diabetes; Diabetic Foot Ulcer; Wound Infection

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Mean change in HbA1c from baseline to end of treatment

  6 months

Secondary Outcomes (12)

• Glycemic control

  6 months

• Foot ulcer and/or wound healing

  6 months

• Patient reported satisfaction with diabetes treatment

  6 months

• Patient reported health status

  6 months

• Proportion of patients with emergency department visits

  6 months

Other Outcomes (1)

• Frequency of hypoglycemic events

  6 months

Study Arms (2)

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.

Device: Telcare 2.0 BGM

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.

Interventions

Telcare 2.0 BGM DEVICE

Blood glucose meter that uploads blood glucose measurements to a cloud server that providers can access and use to monitor patients' glycemic trends.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Type 2 Diabetes
• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Parkland Health and Hospital System: collaborator

Study Sites (1)

Parkland Health and Hospital System

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Diabetes Complications; Diabetes Mellitus; Diabetic Foot; Wound Infection

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Neuropathies; Infections

Study Officials

• Uma Gunasekaran, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Internal Medicine

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: February 4, 2019
• Study Start: July 9, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 2, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)