Fluorescence Image-Guided Healing Trial

NCT04163055 | Unknown Phase 4 DMC FDA Device

• 1 other identifier: 18-6034
• Study Type: interventional
• Target: 294
• Locations: 0 countries
• Sites: N/A

Brief Summary

Lower extremity complications such as chronic diabetic foot ulcers (DFUs) are a major risk for Type I/II diabetes patients. Minor injuries that would normally heal without consequence in non-diabetic individuals are at greater risk of bacterial infection and progression to non healing (chronic) wound status in diabetics, largely due to a loss of sensation in limbs (neuropathy) and decreased blood flow (vascular disease). If not treated efficiently and effectively, DFUs can have serious complications e.g. amputation, sepsis and death. The investigators propose to address this significant unmet clinical need using a novel commercial handheld fluorescence imaging product called the MolecuLight i:X (MolecuLight Inc.) which images clinically-significant wound bacteria without contrast agents or patient contact. Evidence in animal models of chronic wounds and multiple published clinical trials (mainly DFUs) have shown significant clinical potential for fluorescence imaging to detect potentially harmful bacteria in wounds otherwise invisible to doctors. The investigators have shown that clinicians can easily, objectively and more accurately determine the likelihood of bacterial infection than the standard of care. Moreover, published clinical evidence has shown fluorescence imaging enables more accurate microbial wound sampling and guides more targeted debridement of wounds to reduce bacteria levels. Our pilot data also show that when used like this, the i:X device accelerates DFU wound healing, compared with current methods. Thus, the investigators propose to expand the current pilot studies through a statistically-powered 3 y randomized controlled trial to test the therapeutic benefit of fluorescence-guided treatment for DFUs in a larger group of patients. A successful trial could help reduce DFU healing times compared with standard practice (using a new Canadian product) and improve patient quality of life, reduce amputation risk and alleviate health care costs for diabetes complications in Canada and beyond.

Conditions

Diabetic Foot Ulcer

Keywords

Diabetes; Foot Ulcer; Non-healing wound; Targeted debridement

Outcome Measures

Primary Outcomes (1)

• The rate of CWH of DFUs will be estimated as a proportion and compared between the two groups using a chi square test. The superiority of AF-guided intervention (Arm 2) will be established if the null hypothesis is rejected.

  CWH is defined as 100% re-epithelialization, and will be recorded and validated by independent review. The % of patients achieving CWH will be evaluated at 6- and 12-wk and compared between study arms (time point based on previously published data regarding wound healing in DFUs). Time to CWH will also be recorded and compared between study arms. PWH is defined as a reduction in wound area (WA) of ≥50% relative to baseline, but not meeting criteria of CWH. The % of patients achieving PWH will be evaluated at 6 and 12-wk and compared between study arms. To validate CWH, images of wounds identified as having reached 100% re-epithelialization by the wound care clinician will be photographed under WL and sent for review by at least 2 independent blinded researchers.

  12 weeks

Secondary Outcomes (7)

• Rate of Wound Healing

  12 weeks

• The percent reduction in wound area

  12 weeks

• The bioburden of the wound identified and quantified

  12 weeks

• To evaluate cost effectiveness and cost utility of the device on treatment

  12 weeks

• Quality of Life improvement due to the device as assessed by EuroQol-5D-5L

  12 weeks

Study Arms (2)

Standard of Care

NO INTERVENTION

Wounds will be assessed using the Clinical Signs and Symptoms Checklist (CSSC). After initial assessment, a white-light (WL) photo will be taken of the wound. The wound bed will be prepared as indicated by clinical staff based on standard of care (SoC), including irrigation and debridement. A second WL image will be taken and a swab/biopsy will be obtained from the wound. Wounds will be dressed based on SoC.

Autofluorescence guided Standard of Care

EXPERIMENTAL

Wounds will be assessed by autofluorescence (AF)-guided SoC. A baseline WL and AF photo will be taken of the wound. AF images will guide SoC including targeted debridement of areas of bacterial growth (AF+) and targeted sampling in areas of residual bacterial growth post-debridement. If no bacterial AF is detected, sample will be obtained from the wound center by curettage technique. If AF is detected, AF-guided debridement will be repeated and additional images will be obtained until 1) no AF is detected or 2) further debridement is not medically advised. After wound bed preparation, a second set of WL and AF images will be taken. Wounds will be dressed as per SoC. At all visits, samples will be sent for microbiology analysis. At 6- and 12-week visits (or any other scheduled visits in between), microbiology reports will be shared with clinicians if they were not collected outside of SoC.

Device: Moleculight i:X

Interventions

Moleculight i:X DEVICE

This device is used to visualize the bacteria in the wound. Patients do not need consume any contrast agent prior to imaging. The device does not come in contact with the wound.

Autofluorescence guided Standard of Care

Eligibility Criteria

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

You may qualify if:

• Diagnosed with type I or II diabetes
• Presents with one or more chronic or acute DFUs of known or unknown infection status
• Presents with a DFU with surface area that has reduced \<25% in the last 4 weeks
• Braden Score ≥13-14 (Moderate Risk)
• Toe-Brachial Index \> 0.5 (Mild-Normal)

You may not qualify if:

• Wounds \< 1 cm in diameter
• Current or past (within 1 month) treatment of DFU with antibiotics
• Treatment with an investigational drug within 1 month of enrolment
• Presents with chronic (\>10mg/kg for \>30 days) systemic corticoids before enrolment
• Undergoing chemotherapy or is immunocompromised
• Diagnosed with Charcot disease or ulcers from electrical, chemical or radiation burns
• Presents with collagen vascular disease, ulcer malignancy, cellulitis, or chronic osteomyelitis (defined as a severe, persistent and sometimes incapacitating infection of bone and bone marrow).
• Recombinant or autologous growth factors or skin/dermal substitutes within 30 days of enrollment
• Enzymatic debridement
• Acquired a limb-threatening infection which necessitates an amputation
• InfectionHas a terminal illness
• Inability to consent

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Foot Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Foot Diseases

Central Study Contacts

Vasanth Subramanian, MS

CONTACT

4166348754; vasanth.subramanian@uhnresearch.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 14, 2019
• Study Start: January 1, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 31, 2022
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share