Treatment of diabetic foot wounds with cold plasma plaster.

Completed

• Conditions: Plasma GasesAdultDiabetic footUlcerDiabetische voetUlcusPlasma pleisterVolwassenen

• Registration Number: NL-OMON22100
• Lead Sponsor: VU University Medical Center.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

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, with or without peripheral vascular disease, 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) [17]

Exclusion Criteria

-Implanted electrical medical devices such cardiac pacemakers

-Life-threatening cardiac conductivity abnormality

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of CAP treatment in diabetic foot ulcers. CAP treatment is considered safe when in ≤ 10% serious adverse advents other than infection occur, and if ≤ 60% of patients have infection.

Secondary Outcome Measures

Name	Time	Method
• The effect of CAP treatment on bacterial load is considered clinically significant if bacterial load is reduced with 50% at day 14 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, 7 and 14.<br /><br>• Healing of the wound, defined as full epithelialization, at 2 and 12 weeks after start of treatment.<br /><br>• 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.<br /><br>• Clinical outcome (amputation, death, wound healing, treatment with antibiotics) 3 months after enrolment. <br /> <br>• Quality of life 3 months after enrolment measured with questionnaires (PAID-NL, SF-36, USER-P).