Treatment of diabetic foot wounds with cold plasma plaster.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22100

Enrollment

Registered

2015-03-11

Start date

2016-04-18

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plasma Gases Adult Diabetic foot Ulcer Diabetische voet Ulcus Plasma pleister Volwassenen

Interventions

20 patients with foot ulcers will be treated on an outpatient basis with daily CAP for 10 days in 2 weeks. Bacterial load will be measured by culture and molecular technique of deep tissue swab at day

Eligibility

Inclusion criteria

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] - Able and willing to comply with the research protocol.

Exclusion criteria

Exclusion criteria: - Implanted electrical medical devices such 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 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

Measure	Time frame
• 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. • 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, wound healing, treatment with antibiotics) 3 months after enrolment. • Quality of life 3 months after enrolment measured with questionnaires (PAID-NL, SF-36, USER-P).	—

Measure

Time frame

• 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. • 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, wound healing, treatment with antibiotics) 3 months after enrolment. • Quality of life 3 months after enrolment measured with questionnaires (PAID-NL, SF-36, USER-P).

—

Contacts

Public ContactR.S. Lagrand

VU University Medical Center - Department: Rehabilitation Medicine

r.lagrand@vumc.nl+31 20 444 1180

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)