Cold Atmospheric Pressure Plasma as a Novel Treatment Modality in Diabetic Foot Ulcers: a Pilot Study

Completed

Conditions: Diabetic foot ulcer
diabetic foot wound.
10012653

Registration Number: NL-OMON45010

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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

- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety of cold plasma plaster treatment in diabetic foot ulcers. Cold plasma<br /><br>plaster treatment is considered safe when in * 10% serious adverse advents<br /><br>grade other than infection occur due to treatment within 30 days after the last<br /><br>application of cold plasma, and if * 60% of patients need treatment for<br /><br>infection with surgery or systemic antibiotics within 30 days after the last<br /><br>treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* The effect of cold plasma plaster treatment on bacterial load is considered<br /><br>clinically significant if bacterial load is reduced with 50% at day 10 compared<br /><br>to day 1 as measured by deep tissue swab, and 50% reduction in bacterial load<br /><br>before and directly after cold plasma plaster treatment on day 1, 5 and 10.<br /><br>* Healing of the wound, defined as full epithelialization, at 2 and 12 weeks<br /><br>after start of treatment.<br /><br>* Occurrence of clinically defined infection according to the International<br /><br>Working Group on the Diabetic Foot/Infectious Diseases Society of Americas<br /><br>classification [15,16] during treatment and after treatment.<br /><br> Clinical outcome (amputation, death, treatment with antibiotics) 3 months<br /><br>after enrolment.<br /><br>* Quality of life 3 months after enrolment measured with questionnaires<br /><br>(PAID-NL, SF-36, USER-P).</p><br>