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| Name | Class |
|---|---|
| Venenklinik Bellevue | OTHER |
| Kantonsspital Nidwalden | UNKNOWN |
| Spital Männedorf | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined SOC/Pio treatment | Experimental | Prospective trial (1 month SOC, 2 month SOC + Pio Medical Device, 1 month SOC follow-up) month, with collection of endpoints every second week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pio Medical Device | Device | The Pio device combines the technologies of pulse modulated magnetic fields and light emission locally applied to the wound area. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse event | 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. | At each visit, up to 16 weeks |
| Severity of adverse event | 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. | At each visit, up to 16 weeks |
| Time of occurrence of adverse event | 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. | At each visit, up to 16 weeks |
| Type of adverse event | 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. | At each visit, up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wound area | The wound area will be measured weekly right before the Pio treatment. | At first visit of the week, before Pio treatment, up to 16 weeks |
| Wound volume | The wound volume will be measured weekly right before the Pio treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jürg Traber, Dr. med | Venenklinik Bellevue | Principal Investigator |
| Christiane Bittner, Dr. med. | Kantonsspital Nidwalden | Principal Investigator |
| Georg Liesch, Dr. med | Spital Männedorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Nidwalden | Stans | Ennetmooserstrasse 19 | 6370 | Switzerland | ||
| Venenklinik Bellevue |
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| At first visit of the week, before Pio treatment, up to 16 weeks |
| Kreuzlingen |
| 8280 |
| Switzerland |
| Spital Männedorf | Zurich | 8708 | Switzerland |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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