UnknownNot Applicable

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

Taiwan210 participantsStarted 2022-02-01

Plain-language 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.

Who can participate

Age range

20 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 20 ≤ age \< 80
. Body mass index (BMI) \< 35 kg/m2
. Glycated hemoglobin (HbA1c) \< 10%
. Target ulcer: (1) 10 ≤ size \< 100 cm2 (2)Located on or below malleolus (3)Wagner's grade 2 or 3 initially (4)Margin \> 3 cm between target ulcer and other ulcers
. Transcutaneous oxygen pressure (TcPO2) ≥ 30 mmHg and 0.8 ≤ ankle-brachial index (ABI) ≤ 1.2
. Patient willingness and signed informed consent

Exclusion criteria

. Pregnancy
. Type I diabetes mellitus (Type I DM)
. Active malignancy
. Taking glucocorticoids, immunosuppressants, or in an immunocompromised status
. Lab test upon admission for reconstruction surgery: (1) hemoglobin (Hb) \< 8.0 g/dL, or white blood cell (WBC) \< 3000 cell/μg (2) aspartate aminotransferase (AST) / alanine aminotransferase (ALT) / total bilirubin \> 3x upper normal limits (3) albumin \< 2.5 g/dL

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Complete healing time

Timeframe: 180 days after reconstruction surgery

Wound healing rate on 30, 60, 90 and 180 days

Timeframe: 180 days after reconstruction surgery

Artificial dermis (AD) or split-thickness skin graft (STSG) take rate

Timeframe: 21 days after reconstruction surgery

Trial details

NCT IDNCT05873049

SponsorTaipei Medical University Shuang Ho Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-31

View on ClinicalTrials.gov More Infection, Surgical Site trials