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

Infection, Surgical Site Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Infection, Surgical Site
• Surgical Wound Infection

• NCT number: NCT05873049
• Study type: Interventional
• Source: Taipei Medical University Shuang Ho Hospital
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2022
• Completion date: October 1, 2024