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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Infection, Surgical Site
• Intervention / Treatment: Device: MolecuLight

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 Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 235
    • Shuang Ho Hospital First Medical Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluorescence-guided; Patients who used MolecuLight to achieve "high-quality de-colonization" during reconstruction surgery with artificial dermis or split-thickness skin graft	Device: 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.
No Intervention: Control; Patients who did not use MolecuLight to achieve "high-quality de-colonization" during reconstruction surgery with artificial dermis or split-thickness skin graft

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of bacteria before MolecuLight de-colonization	The percentage of bacteria after the last debridement without using MolecuLight to do de-colonization.	Immediately after last debridement
Percentage of bacteria after MolecuLight de-colonization	The percentage of bacteria after using MolecuLight to do de-colonization.	Immediately after de-colonization with MolecuLight
Wound surface area on 30, 60, 90 and 180 days	The surface area of wound 30, 60, 90 and 180 days after reconstruction surgery.	30, 60, 90 and 180 days after reconstruction surgery
Reasons for poor AD or STSG take rate	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	21 days after reconstruction surgery
Complications on 180 days	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	180 days after reconstruction surgery
Vancouver scar score on 180 days	The vancouver scar score of wound evaluated 180 days after reconstruction surgery.	180 days after reconstruction surgery.

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital
• Investigators: Principal Investigator: Shun-Cheng Chang, Director, Taipei Medical University Shuang Ho Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Anticipated): March 31, 2024
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: diabetic foot ulcer; autofluorescence; fluorescence imaging; split thickness skin graft; non-infected; MolecuLight; artificial dermis
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Infections; Postoperative Complications; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Wound Infection; Diabetic Foot; Foot Ulcer; Surgical Wound Infection
• Other Study ID Numbers: N

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes