Clinical trial NCT05873049: Use of Real-time Fluorescence Imaging in Diabetic Foot Ulcers: the Impact of Colonization
Official title: Use of Real-time Fluorescence Imaging in Diabetic Foot Ulcers: A New Strategy to Assess Residual Bacterial Colonization Before Application of Artificial Dermis or Split-thickness Skin Graft
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infection, Surgical Site
Keywords: diabetic foot ulcer
non-infected
autofluorescence
fluorescence imaging
MolecuLight
artificial dermis
split thickness skin graft
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 210
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Diabetic foot ulcers (DFU) are the main cause of hospitalization in diabetic patients. These hard-to-heal ulcers have a high amputation rate, and a 5-year mortality rate of 50% once being amputated. Treatments for DFU include infection management, wound debridement, revascularization, pressure off-loading, etc. Recently, a novel imaging device called MolecuLight i:X was introduced to help visualize clinically undetectable fluorescent bacteria in wounds and has shown promising effects in the identification of infection. However, as microorganisms almost colonize all chronic wounds, the term "bacterial colonization" should be distinguished from clinical infection. While infection delays the healing process, the impact of colonization on wound reconstruction remains unclear; and the assessment is often more difficult on DFU patients with peripheral neuropathy and vascular diseases. In the present study, investigators will conduct a prospective randomized controlled trial to evaluate the clinical outcome of achieving "high-quality de-colonization" with the aid of MolecuLight i:X in the treatment of noninfected DFU patients, and to compare its efficacy between artificial dermis and split-thickness skin graft.

Eligibility criteria: Inclusion Criteria:

1. 20 ≤ age \< 80
2. Body mass index (BMI) \< 35 kg/m2
3. Glycated hemoglobin (HbA1c) \< 10%
4. 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
5. Transcutaneous oxygen pressure (TcPO2) ≥ 30 mmHg and 0.8 ≤ ankle-brachial index (ABI) ≤ 1.2
6. Patient willingness and signed informed consent

Exclusion Criteria:

1. Pregnancy
2. Type I diabetes mellitus (Type I DM)
3. Active malignancy
4. Taking glucocorticoids, immunosuppressants, or in an immunocompromised status
5. 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

Primary outcomes:
measure: Complete healing time
timeFrame: 180 days after reconstruction surgery
measure: Wound healing rate on 30, 60, 90 and 180 days
timeFrame: 180 days after reconstruction surgery
measure: Artificial dermis (AD) or split-thickness skin graft (STSG) take rate
timeFrame: 21 days after reconstruction surgery
Secondary outcomes:
measure: Percentage of bacteria before MolecuLight de-colonization
timeFrame: Immediately after last debridement
measure: Percentage of bacteria after MolecuLight de-colonization
timeFrame: Immediately after de-colonization with MolecuLight
measure: Wound surface area on 30, 60, 90 and 180 days
timeFrame: 30, 60, 90 and 180 days after reconstruction surgery
measure: Reasons for poor AD or STSG take rate
timeFrame: 21 days after reconstruction surgery
measure: Complications on 180 days
timeFrame: 180 days after reconstruction surgery
measure: Vancouver scar score on 180 days
timeFrame: 180 days after reconstruction surgery.
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Shuang Ho Hospital First Medical Building
Study officials:
affiliation: Taipei Medical University Shuang Ho Hospital
name: Shun-Cheng Chang, Director
role: PRINCIPAL_INVESTIGATOR
References: