Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04163055 |
| Other study ID # |
18-6034 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2021 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
November 2020 |
| Source |
University Health Network, Toronto |
| Contact |
Vasanth Subramanian, MS |
| Phone |
4166348754 |
| Email |
vasanth.subramanian[@]uhnresearch.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Wound care is a major clinical challenge and presents an enormous burden to health care
worldwide. Wounds Canada describes chronic wounds as "a Canadian healthcare crisis."
According to Wounds Canada and Diabetes Canada, approximately 15% of the 2.3 million diabetic
Canadians will develop a diabetic foot ulcer (DFU) and every 30 seconds someone in the world
loses a toe or limb to diabetes. Diabetics are about 23x more likely to be hospitalized for
amputations, approximately 85% of which are due to a previous DFU. Delayed wound healing has
been linked to a variety of factors including infection, which disrupts key biological
changes at the tissue and cellular level that are associated with the wound healing process.
Standard of care (SoC) of DFU infections involves visual inspection of the wound under white
light (WL) and identification of common signs of infection using the Clinical Signs and
Symptoms Checklist. However, SoC is limited by inconsistent guidelines and subjective
assessment. In addition, visual inspection and WL-guided sampling are inaccurate and
currently, no point-of-care technologies exist to assist the unaided eye. In response to this
gap, Dr. DaCosta (PI) and colleagues at University Health Network developed a handheld
fluorescence imaging platform (MolecuLight i:X) that detects bacterial autofluorescence in
wounds in real-time, at the point-of-care, and without the use of exogenous contrast agents.
The investigators propose a 3-year randomized control trial to test the therapeutic benefit
of AF-image guided intervention on DFU management using the i:X. The research questions are
Q1). Does AF-guided diagnosis and wound bed preparation improve wound healing in DFUs
relative to SoC alone? Q2). Does AF-guided intervention decrease the bioburden in DFUs
relative to SoC alone? Q3). Does AF-guided intervention improve patient quality of life
relative to SoC alone? Q4). Is AF-guided intervention associated with reduced treatment cost?
Primary objective: is to determine if AF-guided diagnosis and wound bed preparation improve
wound healing in DFUs compared to SoC alone. To measure this, the investigators will compare
between study arms i) the frequency of complete wound healing (CWH) at 12 weeks; ii) the
frequency of partial wound healing (PWH) at 6 and 12 weeks, CWH at 6 weeks, and mean
time-to-CWH (days); iii) the reduction in wound size at 12 weeks; and iv) the rate of wound
healing over 12 weeks. Secondary objective: is to determine if AF-guided intervention
decreases the bioburden in DFUs compared to SoC alone by evaluating bacterial diversity and
measuring bacteria load at specified regular intervals over 12 weeks. Tertiary objective: is
to determine if AF-guided intervention is associated with improved quality of life (QoL) and
with reduced treatment costs, which will be measured by using patient questionnaires and the
Canadian Institute for Health Information database.
If successful, this Randomized Control Trial (RCT) will demonstrate that AF image-guided
wound care improves time to CWH or PWH among Ontarians with DFUs by increasing wound healing
rates and reducing bioburden. If our technology can improve CWH by our target of >= 16%
(absolute), an additional 55,000 Canadians could reach CWH by 12 weeks, resulting in reduced
wound care costs and improved QoL. The average cost of treating a DFU is $5000-8000/patient.
Improving the number of patients that achieve CWH by >= 16% will substantially reduce costs
associated with treating DFUs in Canada. The results of this study may inform health policy
decisions and recommendations for changes to current SoC DFU practice guidelines. Health
economic and QoL comparison of AF-guided wound care vs SoC in the proposed RCT will help
define the overall value proposition of the new approach. If the investigators fail to
demonstrate improved wound healing rates, this will also be of value to physicians, patients
and the Canadian health care system. Knowing not to further pursue this line of research is
important in an era of limited funding.
