Diabetic foot Ulcer, Venous leg ulcer Wound on the lower leg in diabetes patients or from venous insufficiency
Conditions
Interventions
The product under investigation is a CE-marked Cold Atmospheric Plasma (CAP) device intended for wound treatment in a hospital setting. In this study, the device will be used outside of its intended p
Sponsors
St. Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria: has a minimum age of 18 years old. is referred to one of the participating hospitals for treatment of a diabetic foot ulcer (DFU) or venous leg ulcer (VLU) with healing stagnation and For VLU: An ulcer on the lower leg resulting from malfunctioning venous valves in the leg veins.For DFU: An ulcer on the foot or lower leg in person with currently or previously diagnosed diabetes mellitus and usually accompanied by neuropathy and/or peripheral artery disease (PAD) in the lower extremity.Note: In patients with both diabetes and chronic venous insufficiency, ulcers will be categorized as DFU in case of symptoms of diabetic neuropathy or loss of protective sensation, and otherwise categorized as VLU. has a wound with a minimum wound surface area of 0.5 cm2 and a maximum diameter of 6 cm (~28 cm2 wound surface area for circular wounds; measured after debridement), Re-staging: Patients who have undergone a vascular intervention may be re-evaluated (re-staged) for eligibility 14 days after the procedure, during an outpatient visit (at the hospital), provided that perfusion has been adequately restored and all other inclusion and exclusion criteria are met. This applies to patients with Peripheral Artery Disease (PAD) who have undergone revascularization, as well as patients with Chronic Venous Disease (CVD) who have undergone venous interventions. The type and date of the procedure must be documented in the eCRF (Case Report Form).
Exclusion criteria
Exclusion criteria: Exclusion criteria A potential participant who meets any of the following criteria will be excluded from participation in this study if: the participant has one or more of the following contraindications for PLASOMA: extreme exudative wounds, i.e. wounds in which moisture is visible within seconds after patting dry; any implanted active electronic device, such as a pacemaker, is present; an electronic medical device attached to the body, for example electronic life support equipment, a hearing aid, insulin pump or dialysis machine. If this medical device can be disconnected, PLASOMA treatment may be performed. If the sole purpose of this medical device is monitoring, such as a glucose sensor, PLASOMA treatment is not contra-indicated but note that use of PLASOMA together with such devices has not been tested and may lead to erroneous operation of the attached device during PLASOMA treatment;metal in the area 10 cm around pad-electrode area, e.g. metal sutures and implants;connection from outside the body to (near) the heart is present, e.g. a central venous catheter;the participant has epilepsy; the participant is pregnant. the participant has more than one wound that requires professional wound care. for DFU the WIfI-classification is wound grade 3, defined as an extensive, deep ulcer involving forefoot and/or midfoot; deep, full thickness heel ulcer + calcaneal involvement.presence of ischemia grade 2 or 3, according to the WIfI classification (= the ankle-brachial pressure index (ABI) is =0.59 OR the ankle systolic pressure is =69 mmHg OR the toe pressure is =39 mmHg; there should be at least one of these three measurements available). a deep infection defined as an infection of the wound involving structures deeper than skin and subcutaneous tissues (e.g., abscess, osteomyelitis, septic arthritis, fasciitis). the wound is located on a toe. the participant receives treatment with immunosuppressive agents or oral corticosteroids; no exclusion if participant has received a stable dose for at least 2 months and the oral corticosteroid dose does not exceed 7.5 mg/day prednisone or equivalent. the participant is receiving or likely to receive offloading with a total contact cast or advanced wound therapies – such as negative pressure therapy, hyperbaric oxygen therapy, biologicals (e.g. skin substitutes, growth factors), electrophysical therapy – for the to be-treated wound. Advanced wound dressings (including but not limited to hydrocolloid, hydrogel, alginate, collagen and antimicrobial dressings) are not excluded. presence of a chronic or active skin disorder that may negatively influence wound healing (such as Marfan or Ehlers-Danlos syndrome). the participant takes part in another study that is likely to compromise the outcome of this study or the feasibility of the participant fulfilling this study. the participant is lactating. the participant is unable to provide consent. Justification: There is no specific inclusion criterion regarding insufficient healing with SWC, since patients will only be referred to the hospitals if their wound has healed ins
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point is ‘ulcer-free survival days’ defined as the number of days within the follow-up period where the participant is alive and has no ulcer on the same foot or limb. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end points include the wound healing rate, time to wound healing, surface area reduction, recurrences, pain, new ulcer formation, infection, occurrence of adverse events, presence of amputations, quality of life and to evaluate the cost-effectiveness of CAP in comparison to SWC. | — |
Countries
Netherlands
Contacts
Public ContactM Loizou
St. Antonius Ziekenhuis
Outcome results
None listed