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Diabetic Foot Ulcer and Wound Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03827902
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
Parkland Health & Hospital System
Information provided by (Responsible Party):
Uma Gunasekaran, University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment
Diabetes Complications Diabetes Diabetic Foot Ulcer Wound Infection Device: Telcare 2.0 BGM

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.

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Study Type : Observational
Estimated Enrollment : 106 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Remote Glycemic Management for Patients With Diabetic Foot Ulcer and Wound Infection
Actual Study Start Date : July 9, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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.



Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: 6 months ]
    Mean change in HbA1c from baseline to end of treatment


Secondary Outcome Measures :
  1. Glycemic control [ Time Frame: 6 months ]
    Proportion of patients with lower A1C and insulin use

  2. Foot ulcer and/or wound healing [ Time Frame: 6 months ]
    Complete wound healing as defined by University of Texas Health System

  3. Patient reported satisfaction with diabetes treatment [ Time Frame: 6 months ]
    Self-reported outcome assessment questionnaire using the Diabetes Treatment Satisfcation Questionnaire (DTSQ) [Scale range 0-48]; lower scores represent worse outcomes

  4. Patient reported health status [ Time Frame: 6 months ]
    Self-reported outcome assessment questionnaires using the 5 level EQ-5D health status measure (EQ-5D-5L) [Scale range 5-25]; higher scores represent worse outcome

  5. Proportion of patients with emergency department visits [ Time Frame: 6 months ]
    Proportion of patients with emergency department visits following enrollment

  6. Proportion of days covered score [ Time Frame: 6 months ]
    Proportion of days covered score represents an indirect measure of medication adherence and represents the proportion of days medication was dispensed (numerator) over the total potential days the medication should have been dispensed (denominator)

  7. Proportion of patients with hospitalization [ Time Frame: 6 months ]
    Proportion of patients with hospitalization following enrollment

  8. Frequency of invasive procedures [ Time Frame: 6 months ]
    Total number and type of invasive procedures related to diabetic foot ulcer and or wound infection

  9. Number of outpatient visits [ Time Frame: 6 months ]
    Total number of outpatient visits for general or specialized care (including virtual visits) during trial

  10. Number of casts and boots used for treatment [ Time Frame: 6 months ]
    Total number of casts and boots used for treatment related to diabetic foot ulcer and or wound infection

  11. Overall hospital incurred patient-specific cost [ Time Frame: 6 months ]
    Cost (in US $) of overall patient care for Parkland during study enrollment

  12. Cost of glycemic management during study [ Time Frame: 6 months ]
    • Cost of glycemic management during trial, including cost of encounters (including telephone and virtual visits), testing supplies, drug costs, technology costs specifically related to glycemic management


Other Outcome Measures:
  1. Frequency of hypoglycemic events [ Time Frame: 6 months ]
    Comparison of frequency of severe hypoglycemic symptoms for usual care versus intervention arm



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827902


Contacts
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Contact: Jessica L Phillips, MPH 214-648-1344 jessical.phillips@utsouthwestern.edu
Contact: Uma Gunasekaran, MD 214-648-8476 uma.gunasekaran@utsouthwestern.edu

Locations
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United States, Texas
Parkland Health and Hospital System Recruiting
Dallas, Texas, United States, 75235
Contact: Uma Gunasekaran, MD    214-590-2726    uma.gunasekaran@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Parkland Health & Hospital System
Investigators
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Principal Investigator: Uma Gunasekaran, MD University of Texas Southwestern Medical Center
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Responsible Party: Uma Gunasekaran, Assistant Professor, Internal Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03827902    
Other Study ID Numbers: STU 042018-008
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Wound Infection
Diabetic Foot
Foot Ulcer
Diabetes Mellitus
Diabetes Complications
Ulcer
Wounds and Injuries
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetic Neuropathies
Foot Diseases