MedTrace Logo

Use of Real-time Fluorescence Imaging in Diabetic Foot Ulcers: the Impact of Colonization

NCT05873049 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2023-05-24

No results posted yet for this study

Summary

The study evaluates the efficacy of fluorescence-guided de-colonization in patients with non-infected diabetic foot ulcers. The efficacy will also be compared between those who used artificial dermis and split-thickness skin graft for reconstruction surgery.

Conditions

  • Infection, Surgical Site

Interventions

DEVICE

MolecuLight

MolecuLight is a handheld fluorescence imaging device that is utilized to help real-time visualize clinically undetectable fluorescent bacteria in wounds. It emits a 405 nm wavelength of safe violet light, which interacts with the wound tissue and bacteria causing certain bacteria to emit red or cyan fluorescence. The fluorescence signals were then captured by MolecuLight and those with bacteria at levels of ≥ 10\^4 colony forming units per gram (CFU/g) will be detected and displayed on the screen.

Sponsors & Collaborators

  • Taipei Medical University Shuang Ho Hospital

    lead OTHER

Principal Investigators

  • Shun-Cheng Chang, Director · Taipei Medical University Shuang Ho Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2024-03-31
Completion
2024-10-01
FDA Device
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05873049 on ClinicalTrials.gov