Status:
WITHDRAWN
Diabetic Foot Ulcer and Wound Infection
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Parkland Health and Hospital System
Conditions:
Diabetes Complications
Diabetes
Eligibility:
All Genders
18+ years
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 usu...
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 glycem...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 9 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 2 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03827902
Start Date
July 9 2019
End Date
April 2 2020
Last Update
November 6 2020
Active Locations (1)
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1
Parkland Health and Hospital System
Dallas, Texas, United States, 75235