Primary Objectives- To objectively quantify the spatial and temporal kinetics of perfusion and wound healing using clinical imaging and evaluations between diabetic wounds before and after endovascular revascularization and between diabetic patients…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Efficacy endpoints
Characterization of the DFU / healthy control by:
- Clinical imaging: 2D and 3D photography, LSCI, TEWL, thermography, OCT,
duplex ultrasound and DSA of the arteries of the lower limb
- Clinical evaluation: RYB wound assessment scale, WIfI classification system,
PEDIS score system, TIME wound assessment and TP measurement
Tolerability / safety endpoints
- AEs
- Only for patients:
o Tolerance (RYB wound assessment scale, WIfI classification system, PEDIS
score system, TIME wound assessment)
This is a study using non-invasive assessment methods without the need for
contrast imaging. Since the primary aim is the wound characterization the
treatment is not considered to be investigational in the strict sense of the
protocol. Therefore, we foresee no AEs related to the protocol-related
methodology assessments.
Secondary outcome
N.A.
Background summary
The worldwide population of diabetic patients and associated consequences,
including a diabetic foot ulcer (DFU), is rapidly increasing.
Endovascular revascularization plays an important role in the wound healing
process, but its appropriate first-line strategy for employment is not yet
established. In order to gain more insight into the long-term effects of
revascularization of DFUs, a complete wound assessment can provide more
information and new perspectives in the treatment of such wounds. Combining
multiple interdisciplinary tools provides the opportunity for such assessments.
This combined set of imaging and assessment methodologies can, in a later
stage, be used to research novel wound treatment opportunities.
Study objective
Primary Objectives
- To objectively quantify the spatial and temporal kinetics of perfusion and
wound healing using clinical imaging and evaluations between diabetic wounds
before and after endovascular revascularization and between diabetic patients
and healthy volunteers.
Secondary Objectives
- To characterize and monitor wound healing in DFUs after endovascular
revascularization.
- To assess by multiple non-invasive modalities the local perfusion of feet,
legs, and (non-healing amputation) wounds expressed in pixel density and its
correlation with toe systolic pressure, duplex ultrasound and digital
subtraction angiography.
- To explore the correlation between revascularization and the change in pixel
density measured over time.
- To assess the reliability and repeatability of measurements in healthy
volunteers.
- To monitor for the presence of any tolerability or safety signals.
Study design
This is a multicenter observational cohort study.
Study burden and risks
There is insufficient knowledge on the effects of revascularization to
determine if this procedure will induce (complete) wound healing in individual
patients. This study provides an opportunity to investigate and quantify the
effects of revascularization on the recovery of DFUs over 90 days. In wound
healing, 90 days can be considered long term since normal wounds generally
enter the remodelling phase after 21 days. Therefore, following the process of
wound healing after PTA will yield valuable information for the improvement of
standard care. Participating in this study has no specific direct benefits for
the individual subject. Due to the non-invasive character of this study, risks
are considered to be very minimal. An allergic reaction to ultrasound gel could
be a potential but extremely rarely happening risk.
Zernikedreef 8
Leiden 2333CL
NL
Zernikedreef 8
Leiden 2333CL
NL
Listed location countries
Age
Inclusion criteria
Patients
Eligible patients must meet all of the following inclusion criteria at
screening:
1. Male and female patients with ischemic or neuro-ischemic DFUs, >=18 years of
age.
2. Type 1 or type 2 diabetes mellitus with either oral hypoglycaemic medication
and/or insulin treatment. Any other clinical significant active or uncontrolled
chronic disease than diabetes mellitus will be recorded.
3. Suitable DFU(s) for performing assessments as judged by the investigator or
medically qualified designee.
4. Planned to receive PTA by standard care practice protocol.
5. Willing to give written informed consent and willing and able to comply with
the study protocol.
Healthy volunteers
Eligible gender, age, BMI, and ethnicity-matched healthy subjects must meet all
of the following inclusion criteria at screening:
1. Healthy subjects, male or female, >=18 years of age. The health status is
verified by absence of evidence of any clinical significant active or
uncontrolled chronic disease following a detailed medical history and a
complete physical examination including vital signs. In the case of uncertain
or questionable results, tests performed during screening may be repeated
before randomization to confirm eligibility or judged to be clinically
irrelevant for healthy subjects.
2. Willing to give written informed consent and willing and able to comply with
the study protocol.
Exclusion criteria
Patients
Eligible patients will be excluded if any of the following exclusion criteria
apply at screening:
1. Presence of wounds other than non-healing amputation wounds or DFUs (e.g.
due to trauma, ingrown toenails, or tophaceous gout).
2. Have any current and/or recurrent pathologically relevant skin or vascular
condition other than chronic vascular insufficiency.
3. Any (medical) condition that would, in the opinion of the investigator,
potentially compromise the safety or compliance of the subject or may preclude
the subject*s successful completion of the clinical trial.
Healthy volunteers
Eligible gender, age, BMI, and ethnicity-matched healthy subjects will be
excluded if any of the following exclusion criteria apply at screening:
1. Presence of wounds on legs or feet.
2. Have any current and/or recurrent pathologically relevant skin or vascular
condition.
3. Participation in an investigational drug or device study within 3 months
prior to screening or more than 4 times a year.
4. Use of topical medication (prescription or over-the-counter (OTC)) within 30
days of the start of the study in local treatment area (legs and feet).
5. Any (medical) condition that would, in the opinion of the investigator,
potentially compromise the safety or compliance of the subject or may preclude
the subject*s successful completion of the clinical trial.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL69946.098.19 |
| OMON | NL-OMON29273 |