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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05873049
• Other study ID #: N
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: May 2023
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 210
• Est. completion date: October 1, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Shuang Ho Hospital First Medical Building	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete healing time	The time for complete wound epithelialization or closure without drainage after reconstruction surgery.	180 days after reconstruction surgery
Primary	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
Primary	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	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
Secondary	Percentage of bacteria after MolecuLight de-colonization	The percentage of bacteria after using MolecuLight to do de-colonization.	Immediately after de-colonization with MolecuLight
Secondary	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
Secondary	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
Secondary	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
Secondary	Vancouver scar score on 180 days	The vancouver scar score of wound evaluated 180 days after reconstruction surgery.	180 days after reconstruction surgery.