Diabetic foot ulcer diabetic foot wound.
Conditions
Interventions
Patients will be treated on an outpatient basis with daily cold plasma
treatment for 10 days in 2 weeks. Other than cold plasma, standard protocols
for wound treatment will be deployed, including wo
Adult
Diabetic foot
Plasma Gases
Ulcer
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Type 1 or 2 diabetes mellitus - Foot ulcer with a maximum depth of 5 millimeters, without evidence of bone or joint tissue in the wound base, without overt clinical infection (University of Texas Wound Classification A1, A2, C1 or C2) - Able and willing to comply with the research protocol.
Exclusion criteria
Exclusion criteria: - Implanted electrical medical devices such as cardiac pacemakers - Life-threatening cardiac conductivity abnormality - Active malignancy - Pregnant or lactating women - Women of childbearing age not using contraceptive measures - A foot infection needing antibiotic treatment - Patients with deep wounds (> 5 millimeters) or with bone or joint tissue in the wound base.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of cold plasma plaster treatment in diabetic foot ulcers. Cold plasma plaster treatment is considered safe when in * 10% serious adverse advents grade other than infection occur due to treatment within 30 days after the last application of cold plasma, and if * 60% of patients need treatment for infection with surgery or systemic antibiotics within 30 days after the last treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| * The effect of cold plasma plaster treatment on bacterial load is considered clinically significant if bacterial load is reduced with 50% at day 10 compared to day 1 as measured by deep tissue swab, and 50% reduction in bacterial load before and directly after cold plasma plaster treatment on day 1, 5 and 10. * Healing of the wound, defined as full epithelialization, at 2 and 12 weeks after start of treatment. * Occurrence of clinically defined infection according to the International Working Group on the Diabetic Foot/Infectious Diseases Society of America*s classification [15,16] during treatment and after treatment. * Clinical outcome (amputation, death, treatment with antibiotics) 3 months after enrolment. * Quality of life 3 months after enrolment measured with questionnaires (PAID-NL, SF-36, USER-P). | — |
Countries
The Netherlands
Outcome results
None listed