Infection, Surgical SiteNCT05873049
Use of Real-time Fluorescence Imaging in Diabetic Foot Ulcers: the Impact of Colonization
A study testing MolecuLight in people with Infection, Surgical Site, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Infection, Surgical Site
- What is being tested?
- MolecuLight
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2022to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 ≤ 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- MolecuLight
- Keywords
- diabetic foot ulcer, non-infected, autofluorescence, fluorescence imaging, MolecuLight, artificial dermis, split thickness skin graft
- Medical subject headings
- Surgical Wound Infection, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MolecuLightDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Fluorescence-guided | Experimental | Patients who used MolecuLight to achieve "high-quality de-colonization" during reconstruction surgery with artificial dermis or split-thickness skin graft Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete healing time
The time for complete wound epithelialization or closure without drainage after reconstruction surgery.
Measured: 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.
Measured: 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.
Measured: 21 days after reconstruction surgery
Secondary outcomes (6)
Percentage of bacteria before MolecuLight de-colonization
The percentage of bacteria after the last debridement without using MolecuLight to do de-colonization.
Measured: Immediately after last debridement
Percentage of bacteria after MolecuLight de-colonization
The percentage of bacteria after using MolecuLight to do de-colonization.
Measured: 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.
Measured: 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
Measured: 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
Measured: 180 days after reconstruction surgery
Vancouver scar score on 180 days
The vancouver scar score of wound evaluated 180 days after reconstruction surgery.
Measured: 180 days after reconstruction surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Feb 2022
- Primary completion31 Mar 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Surgical SiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang shun cheng, Taipei Medical University Shuang Ho Hospital
- Investigators
- Shun-Cheng Chang, Director, Principal investigator, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873049
- Sponsor's protocol ID
- N
- Status last verified
- May 2023
- First submitted
- 14 Jun 2022
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05873049
- Acronym / sponsor ID
- N
- Conditions
- Infection, Surgical Site
- Keywords
- diabetic foot ulcer, non-infected, autofluorescence, fluorescence imaging, MolecuLight, artificial dermis, split thickness skin graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluorescence-guided | Experimental | Device: MolecuLightPatients who used MolecuLight to achieve "high-quality de-colonization" during reconstruction surgery with artificial dermis or split-thickness skin graft |
| 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 |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 20 ≤ 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MolecuLightMolecuLight 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. | Device | Fluorescence-guided |
Primary outcome
Complete healing time
Time frame: 180 days after reconstruction surgery
The time for complete wound epithelialization or closure without drainage after reconstruction surgery.
Wound healing rate on 30, 60, 90 and 180 days
Time frame: 180 days after reconstruction surgery
The healing percentage of wound 30, 60, 90 and 180 days after reconstruction surgery.
Artificial dermis (AD) or split-thickness skin graft (STSG) take rate
Time frame: 21 days after reconstruction surgery
The take percentage of artificial dermis or split-thickness skin graft 21 days after reconstruction surgery.
6 secondary outcomes
Percentage of bacteria before MolecuLight de-colonization
Time frame: Immediately after last debridement
Percentage of bacteria after MolecuLight de-colonization
Time frame: Immediately after de-colonization with MolecuLight
Wound surface area on 30, 60, 90 and 180 days
Time frame: 30, 60, 90 and 180 days after reconstruction surgery
Reasons for poor AD or STSG take rate
Time frame: 21 days after reconstruction surgery
Complications on 180 days
Time frame: 180 days after reconstruction surgery
Vancouver scar score on 180 days
Time frame: 180 days after reconstruction surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shun-Cheng Chang, Director principal investigator
Taipei Medical University Shuang Ho Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MolecuLight in people with Infection, Surgical Site, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete healing time (time frame: 180 days after reconstruction surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.