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

NCT05873049 | Unknown FDA Device

• 1 other identifier: N
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection, Surgical Site

Keywords

diabetic foot ulcer; non-infected; autofluorescence; fluorescence imaging; MolecuLight; artificial dermis; split thickness skin graft

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Percentage of bacteria before MolecuLight de-colonization

  Immediately after last debridement

• Percentage of bacteria after MolecuLight de-colonization

  Immediately after de-colonization with MolecuLight

• Wound surface area on 30, 60, 90 and 180 days

  30, 60, 90 and 180 days after reconstruction surgery

• Reasons for poor AD or STSG take rate

  21 days after reconstruction surgery

• Complications on 180 days

  180 days after reconstruction surgery

Study Arms (2)

Fluorescence-guided

EXPERIMENTAL

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

Device: MolecuLight

Control

NO INTERVENTION

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

Interventions

MolecuLight 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.

Fluorescence-guided

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ age \< 80
• Body mass index (BMI) \< 35 kg/m2
• Glycated hemoglobin (HbA1c) \< 10%
• 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
• Transcutaneous oxygen pressure (TcPO2) ≥ 30 mmHg and 0.8 ≤ ankle-brachial index (ABI) ≤ 1.2
• Patient willingness and signed informed consent

You may not qualify if:

• Pregnancy
• Type I diabetes mellitus (Type I DM)
• Active malignancy
• Taking glucocorticoids, immunosuppressants, or in an immunocompromised status
• 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

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Shuang Ho Hospital First Medical Building

New Taipei City, 235, Taiwan

Location

MeSH Terms

Conditions

Surgical Wound Infection; Diabetic Foot

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Shun-Cheng Chang, Director

  Taipei Medical University Shuang Ho Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Wound Care Center and Department of Plastic Surgery

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: May 24, 2023
• Study Start: February 1, 2022
• Primary Completion: March 31, 2024
• Study Completion: October 1, 2024
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

TW (1)