Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT07050667
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2025-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Chronic Wounds With Cold Plasma -Plasma Care® vs. Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-08-28', 'releaseDate': '2025-08-07'}, {'resetDate': '2025-09-18', 'releaseDate': '2025-08-29'}, {'resetDate': '2025-10-10', 'releaseDate': '2025-09-23'}], 'estimatedResultsFirstSubmitDate': '2025-08-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014946', 'term': 'Wound Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, multicenter, two-arm, randomized, single-blind, clinical study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2025-06-17', 'studyFirstSubmitQcDate': '2025-06-30', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound area at the end of the study', 'timeFrame': '42 days', 'description': 'Size of the wound area (absolute) in cm2'}, {'measure': 'Size and time course of the wound area at the end of the study', 'timeFrame': '42 days', 'description': 'Average time course in size (absolute) of the wound area in cm2 per visit'}, {'measure': 'Percentage change in wound area at the end of the study', 'timeFrame': '42 days', 'description': 'Wound area as a percentage (from baseline)'}, {'measure': 'Dynamics of the percentage change in wound area from baseline', 'timeFrame': '42 days', 'description': 'Average time course of the percentage in wound area (compared to the initial value)'}], 'secondaryOutcomes': [{'measure': 'pH value', 'timeFrame': '42 days', 'description': 'pH measurement by pH meter'}, {'measure': 'Pain Score', 'timeFrame': '42 days', 'description': 'Pain as measured by the VAS Score (1 - 10)'}, {'measure': 'Infection Score', 'timeFrame': '42 days', 'description': 'Infection, measured by the PGA - Physician Global Assessment Score ranging from 0 (no signs of infection) to 4 (maximal signs of infection); 1-4 is considered infected'}, {'measure': 'Tolerability of treatment', 'timeFrame': '42 days', 'description': 'no problem (e.g. no maceration, deterioration of the wound, blisters) new development/intensification of erythema (maceration, blisters, exudate congestion)'}, {'measure': 'Subjective sensation', 'timeFrame': '42 days', 'description': 'Subjective sensation as given by the patient: 1 (pleasant feeling), 2 (no specific sensation), 3 (unpleasant), 4 (very unpleasant)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['placebo controlled', 'plasma care', 'non thermal plasma', 'cold atmospheric plasma', 'wound healing', 'chronic wounds'], 'conditions': ['Hard to Heal Wounds', 'Infected Wound']}, 'descriptionModule': {'briefSummary': 'Objective: The study aimed to evaluate the wound healing effects of plasma care®, a cold atmospheric plasma device, in patients with chronic wounds.\n\nMethod: A prospective, multicenter, two-arm, randomized, single-blind clinical trial was conducted to compare the effectiveness of plasma care® versus placebo, both combined with best practice wound care.', 'detailedDescription': "Chronic wounds present a growing global health challenge, significantly affecting patients' quality of life and imposing high treatment costs. Despite advances in wound care, such as bioactive dressings and specialized medical personnel, effective treatment remains difficult due to the complexity of the wounds and underlying conditions.\n\nCold atmospheric plasma (CAP) has recently emerged as a promising treatment. CAP is created by ionizing gas with strong electric fields, producing reactive species that stimulate human cell regeneration while also exhibiting strong antibacterial and antifungal effects-even against antibiotic-resistant strains. This dual action makes CAP especially useful for chronic wounds, which are prone to infections.\n\nCAP also benefits wound healing by lowering wound pH. Chronic wounds often have an alkaline environment conducive to bacterial growth, but CAP shifts the pH toward more acidic levels, supporting cell function and antibacterial activity.\n\nClinical studies have shown CAP significantly improves wound healing by promoting granulation tissue formation, reducing wound size and infection, and alleviating symptoms like redness and itching. CAP has also proven safe, with no mutagenic effects on healthy cells.\n\nDifferent technologies exist to generate CAP, including Dielectric Barrier Discharge (DBD), Plasma Jet, and Surface Micro Discharge (SMD). The plasma care® device used in this study is based on SMD technology, allowing mobile, gas-free use to treat areas up to 13 cm², with treatment dose determined by application duration.\n\nThis study aims to evaluate whether plasma care® provides significantly better healing outcomes in chronic wounds of various types compared to placebo treatment. It also seeks to understand the impact of CAP on wound healing factors such as infection control, pH reduction, and exudate management, alongside patient experiences like pain and tolerability. If successful, this study could establish plasma care® as a valuable new option in chronic wound therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 95 years at the time of consent\n* Presence of chronic wounds of any origin and wound phase (Includes locally infected wounds)\n* Wound size up to 20 x 10 cm (If multiple wounds are present, one wound is designated as the study wound)\n\nExclusion Criteria:\n\n* Pregnant and breastfeeding women\n* Patients on ongoing systemic antibiotic therapy or who received antibiotics within 1 week prior to study start\n* Patients who participated in another study within one month prior to this study\n* Patients with acute wounds\n* Wounds with visible tendons and bones\n* Wounds with more than 30% dry necrosis\n* Allergy or intolerance to cold plasma\n* Patients with wounds covered by primary or secondary dressings'}, 'identificationModule': {'nctId': 'NCT07050667', 'acronym': 'SUPCAP', 'briefTitle': 'Treatment of Chronic Wounds With Cold Plasma -Plasma Care® vs. Placebo', 'organization': {'class': 'INDUSTRY', 'fullName': 'Terraplasma Medical GmbH'}, 'officialTitle': 'Treatment of Chronic Wounds With Cold Plasma -Plasma Care® vs. Placebo: a Multicenter, Two-arm, Randomized, Single-blind, Prospective, Clinical Study', 'orgStudyIdInfo': {'id': 'EK-2-3/2023'}, 'secondaryIdInfos': [{'id': 'PLASMACARE/70/Q1-23', 'type': 'OTHER', 'domain': 'LKH Feldkirch'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Plasma arm', 'description': 'Treatment of patients with cold atmospheric plasma', 'interventionNames': ['Device: Cold atmospheric plasma']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo arm', 'description': 'Placebo control', 'interventionNames': ['Device: Placebo treatment']}], 'interventions': [{'name': 'Cold atmospheric plasma', 'type': 'DEVICE', 'description': 'Treatment of chronic wounds with cold plasma', 'armGroupLabels': ['Plasma arm']}, {'name': 'Placebo treatment', 'type': 'DEVICE', 'description': 'Treatment of chronic wounds with the placebo device', 'armGroupLabels': ['Placebo arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bregenz', 'country': 'Austria', 'facility': 'LKH Bregenz', 'geoPoint': {'lat': 47.50311, 'lon': 9.7471}}, {'city': 'Feldkirch', 'country': 'Austria', 'facility': 'LKH Feldkirch', 'geoPoint': {'lat': 47.23306, 'lon': 9.6}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to austrian legal privacy laws'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Terraplasma Medical GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-08-07', 'type': 'RELEASE'}, {'date': '2025-08-28', 'type': 'RESET'}, {'date': '2025-08-29', 'type': 'RELEASE'}, {'date': '2025-09-18', 'type': 'RESET'}, {'date': '2025-09-23', 'type': 'RELEASE'}, {'date': '2025-10-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Terraplasma Medical GmbH'}}}}