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

NCT ID: NCT05873049

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2024-10-01

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.

Conditions

Infection, Surgical Site

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fluorescence-guided

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

Group Type: EXPERIMENTAL

MolecuLight

Intervention Type: DEVICE

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.

Control

Patients who did not use MolecuLight to achieve "high-quality de-colonization" during reconstruction surgery with artificial dermis or split-thickness skin graft

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chang shun cheng

Director of Wound Care Center and Department of Plastic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shun-Cheng Chang, Director

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Shuang Ho Hospital

Locations

Shuang Ho Hospital First Medical Building

New Taipei City, , Taiwan

Countries

Taiwan

Other Identifiers

N

Identifier Type: -

Identifier Source: org_study_id