Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05579743

Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers

Led by Johns Hopkins University · Updated on 2025-01-24

120

Participants Needed

1

Research Sites

168 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

N

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research is being done to compare two different methods of wound monitoring for chronic wounds: remote wound monitoring using a smartphone app and in-person wound monitoring in a clinic setting. This will be a pilot non-blinded randomized controlled feasibility trial. The investigators will enroll 120 patients with an active diabetic foot ulcer (DFU) who present to the multidisciplinary diabetic foot clinic in Baltimore, Maryland. Patients will be computer randomized 1:1 to receive wound care monitoring using remote DFU monitoring technology or standard in-person monitoring for 12 weeks.

CONDITIONS

Official Title

Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, aged 6 18 years old
  • Currently receiving treatment for a lower extremity wound related to diabetic foot ulcer
  • Able and willing to use a smartphone to assess the wound for the study duration
  • Proficient in English language
Not Eligible

You will not qualify if you...

  • Patients with fewer than 1 dressing change per week
  • Patients with wound size too large to be covered with a single app scan (such as wounds wrapping around the entire leg)
  • Patients with wounds in locations that are difficult to access who do not have a caregiver to assist with wound scans

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States, 21287

Actively Recruiting

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Research Team

C

Caitlin Hicks, MD

CONTACT

S

Sherry Leung

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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