We hypothesise that CAP is a safe treatment that reduces bacterial load on the wound surface and promotes wound healing.
Bron
Verkorte titel
Aandoening
Plasma Gases
Adult
Diabetic foot
Ulcer
Diabetische voet
Ulcus
Plasma pleister
Volwassenen
Ondersteuning
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
Plasma medicine is an innovative field of research with a high potential but with little clinical evidence to its support. Cold atmospheric plasma (CAP) devices generate an ionized gas with a cocktail of highly reactive species and UV light. They can be used for application on living tissue because these operate at normal ambient air pressure and temperature¹²³. CAP treatment has advantages over antiseptic or antimicrobial infection prevention and control, e.g. efficient, painless, instant disinfection without chance of developing antimicrobial resistance, but with stimulation of fibroblast proliferation and migration contributing to wound healing. Current evidence for CAP consists of in-vitro studies, animal studies, and studies in patient groups such as those with burn wounds. Our novel type of CAP device⁴ is simple to use and can be applied by a podiatrist and even at a patient’s home. This is a pilot study to safety and efficacy of the technology.
Doel van het onderzoek
We hypothesise that CAP is a safe treatment that reduces bacterial load on the wound surface and promotes wound healing.
Onderzoeksopzet
1-7-2015 inclusion patients 1-10.
1-11-2015 intermediate evaluation.
1-12-2015 inclusion patients 11-20.
1-4-2016 evaluation.
Onderzoeksproduct en/of interventie
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 days 1, 7 and 14, and directly before and after CAP application. Standard protocols for wound treatment will be deployed, including proper offloading.
Publiek
R.S. Lagrand
Room PK-1Y066, De Boelelaan 1117
Nijmegen 1081HV
The Netherlands
+31 20 444 1180
r.lagrand@vumc.nl
Wetenschappelijk
R.S. Lagrand
Room PK-1Y066, De Boelelaan 1117
Nijmegen 1081HV
The Netherlands
+31 20 444 1180
r.lagrand@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL4968 |
NTR-old | NTR5090 |
Ander register | 2001440 : VU University Medical Center |