An observational study to characterize chronic wounds in patients with diabetic foot ulcers (DFUs)
- Conditions
- Wound healing10014982
- Registration Number
- NL-OMON52900
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
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.
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Efficacy endpoints<br /><br>Characterization of the DFU / healthy control by:<br /><br>- Clinical imaging: 2D and 3D photography, LSCI, TEWL, thermography, OCT,<br /><br>duplex ultrasound and DSA of the arteries of the lower limb<br /><br>- Clinical evaluation: RYB wound assessment scale, WIfI classification system,<br /><br>PEDIS score system, TIME wound assessment and TP measurement<br /><br><br /><br>Tolerability / safety endpoints<br /><br>- AEs<br /><br>- Only for patients:<br /><br>o Tolerance (RYB wound assessment scale, WIfI classification system, PEDIS<br /><br>score system, TIME wound assessment)<br /><br><br /><br>This is a study using non-invasive assessment methods without the need for<br /><br>contrast imaging. Since the primary aim is the wound characterization the<br /><br>treatment is not considered to be investigational in the strict sense of the<br /><br>protocol. Therefore, we foresee no AEs related to the protocol-related<br /><br>methodology assessments.</p><br>
- Secondary Outcome Measures
Name Time Method <p>N.A.</p><br>