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Device

CGM for Diabetic Foot Ulcers

N/A

Recruiting

Led By Maya Fayfman, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults aged 18 and over with type 2 diabetes admitted to general medical and surgical services with diabetic foot ulceration with or without infection (cellulitis or osteomyelitis)

Treatment of diabetic foot ulcer with medical management and/or debridement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 16 weeks post-discharge

Awards & highlights

Study Summary

This trial will study the effects of CGM on healing diabetic foot ulcers in patients with diabetes type 2.

Who is the study for?

This trial is for adults over 18 with type 2 diabetes and diabetic foot ulcers (DFUs) that are not at very high risk of amputation. Participants should have a HbA1c level of at least 8.5% and be able to use CGM technology either by themselves or with help. Pregnant or breastfeeding women, those who've used CGM before, or have severe arterial disease aren't eligible.Check my eligibility

What is being tested?

The study compares the effectiveness of Continuous Glucose Monitoring (CGM) systems against standard fingerstick blood glucose monitoring in improving wound healing for diabetic foot ulcers post-discharge from medical services.See study design

What are the potential side effects?

While specific side effects are not listed, using a CGM device may include skin irritation where the sensor is placed, potential allergic reactions to adhesive, and possible inaccuracies leading to mismanagement of glucose levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 with type 2 diabetes and have a diabetic foot ulcer.

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I am receiving treatment for a diabetic foot ulcer.

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My foot ulcer has been present for less than a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 16 weeks post-discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 16 weeks post-discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 weeks post-discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

DFU wound healing rates

Time to DFU healing

Secondary outcome measures

Change in patient reported CGM satisfaction (CGM-SAT)

Change in patient reported Glucose Monitoring Survey (GMS)

Change in patient reported World Health Organization Well-Being Index

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Real time - Continuous glucose monitoringExperimental Treatment3 Interventions

Participants will wear a CGM sensor in the abdomen or arm placed by a study team prior to hospital discharge. Participants will have instructions on how to monitor BG with the CGM device and will use their own glucometer and do fingersticks as needed including for CGM calibration.

Group II: Fingerstick blood glucose (FBG) monitoringActive Control2 Interventions

Participants randomized to this group will monitor blood glucose by performing fingersticks, they will also have the application of CGM but will not be given the receiver to allow for self-monitoring. CGM will only be applied by the research team for monitoring over a 14-day interval at baseline, week 4, week 8, and week 12. Blinding will continue throughout the study. This group will receive training only in home BG monitoring with FBG.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Diabetes Education

2019

Completed Phase 3

~2550

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,640 Previous Clinical Trials

2,560,594 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,490 Total Patients Enrolled

14 Trials studying Diabetic Foot

7,663 Patients Enrolled for Diabetic Foot

Maya Fayfman, MDPrincipal InvestigatorEmory University

2 Previous Clinical Trials

340 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are additional study participants being accepted in this trial?

"Based on clinicaltrials.gov, this study is not presently recruiting participants as of September 19th 2023. It had first been posted to the website October 1st 2023 and has since not updated its status; however, there are 936 alternative medical trials that require subject enrolment at this moment in time."

Answered by AI

What goals are scientists hoping to accomplish through the results of this experiment?

"The objective of this trial, to be monitored for a total period up to 12 weeks following discharge, is the rapidity in DFU healing. Other key outcomes that will be assessed include shifts in patient-reported diabetes distress scores (DDS), CGM satisfaction (CGM-SAT) and Glucose Monitoring Survey (GMS). To measure DDS, mean item scores between 2.0 - 2.9 should signify 'moderate distress' whereas anything above 3.0 would denote as 'high distress'. For GMS ratings it ranges from 1 = "a lot" to 4 = "not at all". Meanwhile changes exceeding"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CGM and DFU Healing Post-discharge

Maya Fayfman 2024. "CGM and DFU Healing Post-discharge". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06054659.