Plasma On chronic Wounds for Epidermal Regeneration - Randomized, controlled clinical trial to investigate the efficacy of plasma therapy for the treatment of chronic, non-healing wounds in comparison to standard wound therapy
- Conditions
- I83.0I70.24L97L98.4Varicose veins of lower extremities with ulcerUlcer of lower limb, not elsewhere classifiedChronic ulcer of skin, not elsewhere classified
- Registration Number
- DRKS00019943
- Lead Sponsor
- Coldplasmatech GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 167
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
The exclusion criteria are divided into patient-specific and wound-specific criteria.
Patient Criteria:
- The patient is younger than 18 years and/or lacks legal capacity
- The patient has already participated in this study
- The patient is already participating in another interventional study
- Pregnant or breastfeeding patients
- The patient has an implanted pacemaker, defibrillator or other active implants
- The patient has a light/sun allergy
- The patient has a silicone allergy
- The patient has had a thrombosis within the last 3 months
- The patient has a systemic and/or chronic infectious disease (e.g., HIV, tuberculosis, hepatitis)
- The patient has a tumour disease
- An ongoing or recently completed chemotherapy or radiotherapy
- The patient is undergoing severe endogenous or drug immunosuppression
- The patient is receiving systemic antibiotic treatment or is receiving/needing antiseptic/antibiotic wound therapy in/near the wound
- The patient does not have the necessary revascularization (paVK)
- The patient requires vital instrumental monitoring in the sense of basic monitoring: near-patient respiratory gas measurement (oxygen, carbon dioxide and inhalation anaesthetic), pulse oximeter, ECG monitoring, blood pressure measurement (non-invasive), an oscillometric blood pressure measurement with automatic mode
- Existing alcohol or drug abuse
- The patient requires dialysis
Wound Criteria:
- The wound is not a chronic wound as defined by study protocol
- The wound is difficult to access or close to exposed vessels
- The wound is critically colonized or infected
- Acute infections in the wound area (radius 5 cm)
- The wound is bleeding profusely. This does not include bleeding immediately after debridement
- The wound is undermined
- The wound is located at the knee or above
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The clinical trial is based on the following primary null hypothesis (H0):<br>There is no significant difference in terms of reduction in area of chronic wounds between standard guideline-based wound therapy with and without initial 4-week plasma treatment. <br><br>The associated alternative hypothesis (HA) is:<br>There is a significant difference in terms of reduction in area of chronic wounds between standard guideline-based wound therapy with and without initial 4 weeks of plasma treatment <br>
- Secondary Outcome Measures
Name Time Method In addition to the reduction in wound area as the primary endpoint, wound-related and patient-related secondary endpoints will be collected to assess changes in wound condition (esp. wound bed) and safety aspects.