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Remote Monitoring for Diabetic Foot Ulcers

N/A
Recruiting
Led By Caitlin Hicks, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
In treatment for lower extremity wound related to diabetic foot ulcer
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial compares two methods to monitor chronic wounds: remote monitoring with a smartphone and in-person clinic visits. 120 patients with diabetic foot ulcers will be enrolled in a 12-week study.

Who is the study for?
This trial is for adults over 18 with diabetic foot ulcers who are receiving treatment, can use a smartphone, and speak English. It's not suitable for those without help to scan wounds in hard-to-reach areas, have infrequent dressing changes, or have wounds too large for a single app scan.Check my eligibility
What is being tested?
The study compares remote monitoring of diabetic foot ulcers using a smartphone app versus traditional in-person clinic visits. Participants will be randomly assigned to one of the two methods and monitored over 12 weeks to assess feasibility and effectiveness.See study design
What are the potential side effects?
Since this trial involves monitoring technology rather than medication, typical drug side effects aren't expected. However, there may be privacy concerns or technical issues with the app that could affect patient experience.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am receiving treatment for a wound from a diabetic foot ulcer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants who successfully complete a weekly wound scan

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Remote wound monitoring technologyExperimental Treatment1 Intervention
Enrolled patients (and their caregivers, if applicable) are given an in-person training on how to use the smartphone app to self-assess their wound during regular dressing changes. Wound assessments are electronically transmitted to a secure, dedicated portal up to once a week for remote review by the study doctors. In-person follow-up is monthly (at the time of enrollment, week 4, week 8, and week 12).
Group II: Standard careActive Control1 Intervention
Patients randomized to receive standard of care will be provided with a wound care plan at the time of enrollment, and then follow-up in clinic on a biweekly basis (week 2, 4, 6, 8, 10, 12) for a wound check and care plan update as needed.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,260 Previous Clinical Trials
14,820,660 Total Patients Enrolled
3 Trials studying Foot Ulcer
241 Patients Enrolled for Foot Ulcer
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,314,954 Total Patients Enrolled
14 Trials studying Foot Ulcer
7,634 Patients Enrolled for Foot Ulcer
Caitlin Hicks, MDPrincipal InvestigatorJohns Hopkins School of Medicine
1 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

Remote wound monitoring technology Clinical Trial Eligibility Overview. Trial Name: NCT05579743 — N/A
Foot Ulcer Research Study Groups: Standard care, Remote wound monitoring technology
Foot Ulcer Clinical Trial 2023: Remote wound monitoring technology Highlights & Side Effects. Trial Name: NCT05579743 — N/A
Remote wound monitoring technology 2023 Treatment Timeline for Medical Study. Trial Name: NCT05579743 — N/A
Foot Ulcer Patient Testimony for trial: Trial Name: NCT05579743 — N/A

Frequently Asked Questions

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

Is this medical investigation still taking in participants?

"Based on the current information available from clinicaltrials.gov, this trial is seeking participants. The research was initially posted on December 8th 2022 and has since been updated at least once."

Answered by AI

What is the participant size of this clinical research endeavor?

"Yes, the data hosted on clinicaltrials.gov confirms that this research effort is currently enrolling subjects. The study was posted for the first time on December 8th 2022 and has been revised since then with a goal of recruiting 120 patients from one location."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What site did they apply to?
Johns Hopkins University School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I've been hospitalized more then 3 times in past 3 years. With no help . Finally. In Feb of 2023. I spent most of month n upmc. They burnt a vein .the main ulcer is kinda healed but now skin is falling off leg. My heal past calf all the way around. Please let me know. I have photos of ankle pre procedure.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers
2023. "Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05579743.
~0 spots leftby May 2024
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