Leg Ulcer Arterial, Leg Ulcer Mixed, Leg Ulcers Venous
Conditions
Brief summary
The demographic shift and the increasing prevalence of chronic wounds represent major challenges for modern health care systems. Classic chronic wounds (venous ulcer, arterial ulcer, mixed ulcer) persist for months or years with a very slow or even no healing progress. Patients suffer from pain and immobility, which dramatically reduces their quality of life. Complications such as infections or tissue necrosis can lead to a bad outcome and amputation of extremities. The Pio device offers a non-invasive and non-toxic therapeutic approach. The system combines the technologies of pulse modulated magnetic fields and light emission locally applied to the wound area. The investigational medical device represents a promising combinational therapeutic approach to synergistically increase the tissues regenerative potential. By stimulating electrophysiological processes at the site of injury, the cells regain its capacity to efficiently regenerate the injured or diseased tissue. It is expected that the patient benefits from a faster healing process, reduced inflammation as well as an improved overall treatment outcome.
Interventions
DEVICEPio Medical Device
The Pio device combines the technologies of pulse modulated magnetic fields and light emission locally applied to the wound area.
Sponsors
Venenklinik Bellevue
Kantonsspital Nidwalden
Spital Männedorf
Piomic Medical AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Informed Consent as documented by signature (Appendix Informed Consent Form) * Male and female patients * Age: 18 - 90 * Chronic wound (venous ulcer, arterial ulcer, mixed ulcer) since at least 4 weeks * Wound area minimal 1 cm2, maximal 50 cm2 * No adaptions for treatment of causal therapy of disease
Exclusion criteria
* Women who are pregnant * Known or suspected non-compliance, drug or alcohol abuse, * Participation in another study with investigational drug within the 30 days preceding and during the present study, * Enrolment of the investigator, his/her family members, employees and other dependent persons, * Patients with active devices (e.g. Pacemakers and defibrillators, infusion devices, insulin pumps) * Metallic implants and endoprosthesis at extremities lower than hip * Life threatening condition * Immunosuppressive after foreign organ transplant or chemotherapeutic treatment within 30 days before study begin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse event | At each visit, up to 16 weeks | The incidence of adverse events will be assessed at each visit, prior to the Pio treatment and directly after the Pio treatment. The incidence of treatment-emergent adverse events will be compared to the incidence of standard of care emergent adverse events. |
| Severity of adverse event | At each visit, up to 16 weeks | The severity of adverse events will be assessed at each visit, prior to the Pio treatment and directly after the Pio treatment. The severity of treatment-emergent adverse events will be compared to the severity of standard of care emergent adverse events. |
| Time of occurrence of adverse event | At each visit, up to 16 weeks | The time of occurrence of adverse events will be assessed at each visit, prior to the Pio treatment and directly after the Pio treatment. The time of occurrence of treatment-emergent adverse events will be compared to the time of occurrence of standard of care emergent adverse events. |
| Type of adverse event | At each visit, up to 16 weeks | The type of adverse events will be assessed at each visit, prior to the Pio treatment and directly after the Pio treatment. The type of treatment-emergent adverse events will be compared to the type of standard of care emergent adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound area | At first visit of the week, before Pio treatment, up to 16 weeks | The wound area will be measured weekly right before the Pio treatment. |
| Wound volume | At first visit of the week, before Pio treatment, up to 16 weeks | The wound volume will be measured weekly right before the Pio treatment. |
Countries
Switzerland
Outcome results
None listed