Diabetes ComplicationsNCT03827902
Diabetic Foot Ulcer and Wound Infection
An observational study of Diabetes Complications and Diabetes, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Complications, Diabetes, Diabetic Foot Ulcer
- What is being tested?
- Telcare 2.0 BGM
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2019to 2 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Parkland Health and Hospital System
Dallas, Texas, 75235
About this study
Official title: Remote Glycemic Management for Patients With Diabetic Foot Ulcer and Wound Infection
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.
Read the 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.
- Conditions
- Diabetes Complications, Diabetes, Diabetic Foot Ulcer, Wound Infection
- Being tested
- Telcare 2.0 BGM
- Medical subject headings
- Diabetes Complications, Diabetes Mellitus, Diabetic Foot, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telcare 2.0 BGMDevice
Blood glucose meter that uploads blood glucose measurements to a cloud server that providers can access and use to monitor patients' glycemic trends.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Mean change in HbA1c from baseline to end of treatment
Measured: 6 months
Secondary outcomes (12)
Glycemic control
Proportion of patients with lower A1C and insulin use
Measured: 6 months
Foot ulcer and/or wound healing
Complete wound healing as defined by University of Texas Health System
Measured: 6 months
Patient reported satisfaction with diabetes treatment
Self-reported outcome assessment questionnaire using the Diabetes Treatment Satisfcation Questionnaire (DTSQ) [Scale range 0-48]; lower scores represent worse outcomes
Measured: 6 months
Patient reported health status
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
Measured: 6 months
Proportion of patients with emergency department visits
Proportion of patients with emergency department visits following enrollment
Measured: 6 months
Proportion of days covered score
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)
Measured: 6 months
Proportion of patients with hospitalization
Proportion of patients with hospitalization following enrollment
Measured: 6 months
Frequency of invasive procedures
Total number and type of invasive procedures related to diabetic foot ulcer and or wound infection
Measured: 6 months
Number of outpatient visits
Total number of outpatient visits for general or specialized care (including virtual visits) during trial
Measured: 6 months
Number of casts and boots used for treatment
Total number of casts and boots used for treatment related to diabetic foot ulcer and or wound infection
Measured: 6 months
Overall hospital incurred patient-specific cost
Cost (in US $) of overall patient care for Parkland during study enrollment
Measured: 6 months
Cost of glycemic management during study
- 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start9 Jul 2019
- Primary completion1 Apr 2020
- Study completion2 Apr 2020
Why it stopped: Unable to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes ComplicationsStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Parkland Health and Hospital System
- Responsible party
- Principal investigator, Uma Gunasekaran, University of Texas Southwestern Medical Center
- Investigators
- Uma Gunasekaran, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827902
- Sponsor's protocol ID
- STU 042018-008
- Status last verified
- Nov 2020
- First submitted
- 17 Jan 2019
- Last updated
- 6 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Glycemic Management for Patients With Diabetic Foot Ulcer and Wound Infection
- ClinicalTrials.gov ID
- NCT03827902
- Acronym / sponsor ID
- STU 042018-008
- Conditions
- Diabetes Complications, Diabetes, Diabetic Foot Ulcer, Wound Infection
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to recruit participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Parkland Health and Hospital System
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 2 Apr 2020 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | – | Device: Telcare 2.0 BGMA 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telcare 2.0 BGMBlood glucose meter that uploads blood glucose measurements to a cloud server that providers can access and use to monitor patients' glycemic trends. | Device | Intervention Group |
Primary outcome
Change in HbA1c
Time frame: 6 months
Mean change in HbA1c from baseline to end of treatment
12 secondary outcomes
Glycemic control
Time frame: 6 months
Foot ulcer and/or wound healing
Time frame: 6 months
Patient reported satisfaction with diabetes treatment
Time frame: 6 months
Patient reported health status
Time frame: 6 months
Proportion of patients with emergency department visits
Time frame: 6 months
Proportion of days covered score
Time frame: 6 months
Proportion of patients with hospitalization
Time frame: 6 months
Frequency of invasive procedures
Time frame: 6 months
Number of outpatient visits
Time frame: 6 months
Number of casts and boots used for treatment
Time frame: 6 months
Overall hospital incurred patient-specific cost
Time frame: 6 months
Cost of glycemic management during study
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uma Gunasekaran, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Complications and Diabetes, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.