Wound healing
Conditions
Interventions
None listed
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| N.A. | — |
Countries
Netherlands
Outcome results
None listed