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

Not Applicable

Active, not recruiting

• Conditions: Infection, Surgical Site
• Interventions: Device: MolecuLight

• Registration Number: NCT05873049
• Lead Sponsor: Taipei Medical University Shuang Ho Hospital

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.

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2022-06-14
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-15
• Last Update Submitted: 2023-05-15
• Study First Posted: 2023-05-24
• Last Update Posted: 2023-05-24
• Primary Completion: 2024-03-31
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluorescence-guided	MolecuLight	Patients who used MolecuLight to achieve "high-quality de-colonization" during reconstruction surgery with artificial dermis or split-thickness skin graft

Primary Outcome Measures

Name	Time	Method
Complete healing time	180 days after reconstruction surgery	The time for complete wound epithelialization or closure without drainage after reconstruction surgery.
Artificial dermis (AD) or split-thickness skin graft (STSG) take rate	21 days after reconstruction surgery	The take percentage of artificial dermis or split-thickness skin graft 21 days after reconstruction surgery.
Wound healing rate on 30, 60, 90 and 180 days	180 days after reconstruction surgery	The healing percentage of wound 30, 60, 90 and 180 days after reconstruction surgery.

Secondary Outcome Measures

Name	Time	Method
Reasons for poor AD or STSG take rate	21 days after reconstruction surgery	Reasons for poor take rate of artificial dermis or split-thickness skin graft 21 days after reconstruction surgery may include as follows: (1) weak graft fixation (2) seroma (3) hematoma (4) wound localized infection (5) osteomyelitis (6) irreversible ischemic ulcers (7) systemic cause
Percentage of bacteria before MolecuLight de-colonization	Immediately after last debridement	The percentage of bacteria after the last debridement without using MolecuLight to do de-colonization.
Percentage of bacteria after MolecuLight de-colonization	Immediately after de-colonization with MolecuLight	The percentage of bacteria after using MolecuLight to do de-colonization.
Wound surface area on 30, 60, 90 and 180 days	30, 60, 90 and 180 days after reconstruction surgery	The surface area of wound 30, 60, 90 and 180 days after reconstruction surgery.
Complications on 180 days	180 days after reconstruction surgery	Complications evaluated 180 days after reconstruction surgery may include as follows: (1) wound recurrence (2) higher-level amputation (3) above or below knee amputation (4) vascular restenosis (5) mortality
Vancouver scar score on 180 days	180 days after reconstruction surgery.	The vancouver scar score of wound evaluated 180 days after reconstruction surgery.

Trial Locations

Locations (1)

Shuang Ho Hospital First Medical Building; 🇨🇳 New Taipei City, Taiwan