Chronic Ulcer of Lower Extremity
Conditions
Brief summary
Every year, 5 million people throughout Germany suffer from extensive, often chronic wounds. Cold plasma is an innovative therapeutic approach in the treatment of these persistent tissue defects. However, previous therapy options with cold plasma are very time-consuming, especially with increasing wound area, and are also strongly dependent on the skill of the practitioner. This study investigates the effectiveness of a system for reproducible application of cold plasma on larger areas and observes the effect of a 4-week additional plasma treatment on wound healing of large chronic wounds. The patient-related benefit of such an additional treatment will also be evaluated. Both study arms will receive guideline-based wound therapy, which is the current gold standard.
Detailed description
The clinical trial investigates the efficacy of an additional 4-week initial plasma therapy (CAPT) in direct comparison to standard guideline-based wound therapy (SWT) alone. The reactivation of healing of chronic, non-healing wounds will be assessed. This reactivation is primarily measured by the reduction of wound area, a valid and clinically accepted parameter for wound healing. A large number of RCTs and cohort studies demonstrate a strong correlation between the reduction in wound area at 4 weeks and the therapy outcome at 12 and 20 weeks. In addition to wound area reduction, other clinical parameters such as wound volume, wound closure, percentage of necrotic and fibrotic tissue, percentage of granulation tissue, wound exudate, and microflora are recorded. By recording these secondary endpoints, it is possible to closely track and analyse changes in wound condition induced by cold plasma. Another focus of the clinical trial is the evaluation of patient-related outcomes such as frequency of occurrence of infections, perception of pain, occurrence of adverse events, frequency of hospitalization, and change in quality of life. These events are fully documented to evaluate the safety of the treatment and to rule out potential risks.
Interventions
DEVICECPtcube, CPTpatch
This study investigates the effectiveness of a system for reproducible application of cold plasma on larger areas and observes the effect of a 4-week additional plasma treatment on wound healing of large chronic wounds.
Sponsors
Coldplasmatech
German Federal Ministry of Education and Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria are divided into patient-specific and wound-specific criteria. Patient Criteria: * Patient must be at least 18 years old (legal age) and legally competent * The patient has at least one diagnosed chronic (existing for at least 8 weeks), non-healing wound due to a UCA or UCV on the lower leg, below the knee * There is a signed consent form dated by the patient's own hand Wound Criteria: * In case of multiple wounds, the largest wound by area will be included in the study if it meets all inclusion criteria and no
Exclusion criteria
and is suitable for use of the investigational product. The target wound is at least 2 cm away from the other wound(s) * The wound was diagnosed - at the time of planned inclusion - more than 8 weeks ago and classified as a chronic wound * The initial wound area is 5 cm²-100 cm2 * The wound can be enclosed completely by the plasma applicator (10 cm x 10 cm) * The wound is not undermined * The wound is located on the lower leg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in area of chronic wounds | 3 visits weekly for 4 weeks | Chronic wound area is measured in square centimeters (cm²) using the SilhouetteStar® computer-assisted image-based wound measurement system. The outcome is the absolute change in wound area from baseline to Day 25, calculated as wound area at Day 25 minus wound area at baseline. |
| Change from baseline in SF-12 Mental Component Summary score at Day 25 | 3 visits weekly for 4 weeks | Mental health-related quality of life is measured using the Mental Component Summary score of the 12-Item Short Form Health Survey (SF-12). The outcome is the change in the SF-12 Mental Component Summary score from baseline to Day 25, expressed in points. The SF-12 scale ranges from 0 to 100, where 50 represents the population average and higher scores indicate a better health status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound closures | during the 4-week active treatment phase, after 3 and after 6 months | Number of participants with wound closure during the 4-week active treatment phase and at the 3-month and 6-month follow-up assessments. |
| Change in wound pain | during the 6-month observation period | Change in wound pain during activity or at rest during the 6-month observation period. Pain was assessed using an NRS with values ranging from 0 to 10. Higher scores indicate worse pain. |
| Change in the amount of germs/bacteria in the wound bed | during the 4-week active treatment phase | For this purpose, swabs are taken before and after treatment. The swabs are then examined in the laboratory with regard to the microflora (germ type and resistance). The bacterial load is measured on a logarithmic scale. Lower values indicate a lower bacterial load and therefore a better outcome. |
Countries
Germany
Contacts
STUDY_DIRECTORRobert Banaschik, Dr.
Coldplasmatech
PRINCIPAL_INVESTIGATORIsabel Zänker, Dr.
Thüringen-Kliniken
Outcome results
None listed