No registrations found.
ID
Source
Brief title
Health condition
Wound healing
Sponsors and support
Intervention
Outcome measures
Primary outcome
Efficacy endpoints
Characterization of the DFU / healthy control by:
- Clinical imaging: 2D and 3D photography, laser speckle contrast imaging (LSCI), trans epidermal water loss (TEWL),
thermography, optical coherence tomography (OCT), handheld duplex ultrasound and digital subtraction angiography (DSA) of
the arteries of the lower limb
- Clinical evaluation: Red-Yellow-Black (RYB) wound assessment scale, WIfI classification system, PEDIS score system, TIME
wound assessment and toe systolic pressure (TP) measurement
Tolerability / safety endpoints
- Adverse Events (AEs)
- Only for patients:
o Tolerance (Red-Yellow-Black (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 of this study is wound characterizat¡on, we foresee no adverse events related to the methodology assessments. However, at all times during the study, patients and subjects will be monitored forthe presence of any adverse events. Any relevant conditions or diseases that arise during the study period will be documented.
Secundary study parameters/outcome of the study (if applicable)
Secondary outcome
N.A.
Background summary
Endovascular revascularization plays an important role in the wound healing process, but its appropriate first-line strategy for employment is not yet established. Moreover, it is unclear which patients benefit from angioplasty. It is suspected that a revascularized lower leg artery generally
remains patent for at least 6 weeks and that this provides a sufficient boost to realize wound healing. However, the knowledge of the exact effects of angioplasty and the actual redeemed perfusion of the local vascular territory of the ischemic DFU is very limited. 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
An innovative wound assessment model provides a solid fundament to be able to improve interventions in DFUs. Thus, the aim of this study is to optimize, but also to assess the repeatability of a series of imaging methodologies in DFU treatment.
Study design
Day 0 - EOS
Intervention
N.A.
Inclusion criteria
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
Eligible patients must meet none of the following exclusion criteria 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 must meet none of the following exclusion criteria 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
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8169 |
| CCMO | NL69946.098.19 |
| OMON | NL-OMON52900 |