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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03112395 |
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Date of registration:
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03/04/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Local Application of Combined Optical and Magnetic Stimulation (COMS) for Treatment of Chronic Wounds: Safety Evaluation
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Scientific title:
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Local Application of Combined Optical and Magnetic Stimulation (COMS) in Patients Suffering From Chronic Wounds at Lower Extremities: Safety Evaluation |
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Date of first enrolment:
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April 25, 2017 |
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Target sample size:
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36 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03112395 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Christiane Bittner, Dr. med. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kantonsspital Nidwalden |
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Name:
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Jürg Traber, Dr. med |
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Address:
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Telephone:
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Email:
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Affiliation:
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Venenklinik Bellevue |
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Name:
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Georg Liesch, Dr. med |
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Address:
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Telephone:
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Email:
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Affiliation:
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Spital Männedorf |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Leg Ulcer Mixed
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Leg Ulcers Venous
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Leg Ulcer Arterial
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Intervention(s)
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Device: Pio Medical Device
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Primary Outcome(s)
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Type of adverse event
[Time Frame: At each visit, up to 16 weeks]
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Incidence of adverse event
[Time Frame: At each visit, up to 16 weeks]
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Time of occurrence of adverse event
[Time Frame: At each visit, up to 16 weeks]
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Severity of adverse event
[Time Frame: At each visit, up to 16 weeks]
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Secondary Outcome(s)
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Wound area
[Time Frame: At first visit of the week, before Pio treatment, up to 16 weeks]
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Wound volume
[Time Frame: At first visit of the week, before Pio treatment, up to 16 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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