{ "data": { "asOf": "2026-10-30T22:26:48.254Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07312513", "title": "Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds", "scientificTitle": "Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds", "status": "completed", "studyType": "interventional", "phase": [], "conditions": [ "Diabetic Ulcers", "Arterial Ulcers", "Venous Ulcers", "Pressure Ulcers", "Postoperative Wounds Healing by Secondary Intention", "Burns and Scalds", "Epidermolysis Bullosa (EB)", "Traumatic Wounds", "Surgical Wounds" ], "interventions": [ { "name": "two sided debridement pad", "type": "DEVICE", "description": "two sided debridement pad" }, { "name": "one sided debridment pad", "type": "DEVICE", "description": "one sided debridment pad" } ], "sponsor": { "name": "Lohmann & Rauscher", "type": "INDUSTRY" }, "locations": [ { "city": "Lodz", "country": "Poland", "facility": "MelissaMed Poradnia" }, { "city": "Lodz", "country": "Poland", "facility": "MIKOMED Sp. z.o.o." }, { "city": "Lublin", "country": "Poland", "facility": "NZOZ Neuromed M. i M. Nastaj" }, { "city": "Ostróda", "country": "Poland", "facility": "Specjalistyczny Osrodek Leczniczo Badawczy" }, { "city": "Wroclaw", "country": "Poland", "facility": "Lecran - Centrum Opieki Nad Ranami-Kunickiego" } ], "outcomes": { "other": [ "Change in wound size", "Results of biopsy or smear", "Removal of biofilm" ], "primary": [ "Relative reduction of fibrinous and necrotic tissue/slough/debris measured by W.H.A.T." ], "secondary": [ "Relative reduction of fibrinous and necrotic tissue/slough/debris measured by he investigator", "Rate of device-related adverse events (device safety)", "Change of wound bed condition, defined by the combination of the following parameters:", "Wound related pain", "Time needed for debridement", "Amount of products", "Patient satisfaction", "User satisfaction" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patient is legally capable\n* Patient has signed written informed consent\n* Presence of one of the following wounds\n\n * Venous lower leg ulcer\n * Arterial ulcer\n * Diabetic ulcer\n * Pressure ulcer\n * Post-operative wound healing by secondary intention\n * Traumatic wound\n * Surgical wound\n * Burn or scald (grade III: after surgical debridement)\n * Epidermolysis Bullosa\n* Wound area \\>4cm2\n* The entire wound area can be displayed on one photo from a distance of 25-30 cm\n* Covered with at least 30% debris, necrosis, slough, fibrotic tissue\n\nExclusion Criteria:\n\n* Known allergy and/or hypersensitivity to Debrisoft® Duo or any of the product components\n* Pregnancy or breast feeding\n* Patient is illiterate\n* Participation in a interventional clinical trial within the last 14 days and during participation in this study\n* Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and/ or interpretation of the study results\n* severe pain or hyperesthesia in the wound area\n* history of drug or alcohol abuse\n* chronic analgesic use (especially opioids) that could influence baseline pain perception\n* cognitive impairment, which may affect the ability to accurately self-report pain\n* Use of anaesthesia before the debridment procedure\n* presence of hard necrotic tissue or other tissue which should not be debrided in general. Other types of hard necrotic tissue requiring debridement, as determined by the investigator, are permitted and may be also pre-moistened before the procedure if deemed necessary", "minimumAge": "18 Years", "healthyVolunteers": false }, "enrollment": { "type": "ACTUAL", "count": 100 }, "startDate": "2025-05-09", "completionDate": "2026-04-02", "lastUpdated": "2026-09-03T00:00:00.000Z", "firstPosted": "2025-12-31T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT07312513" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT07312513", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07312513", "sourceUrl": "https://clinicaltrials.gov/study/NCT07312513", "sourceStatus": "COMPLETED", "retrievedAt": "2026-10-07T04:31:50.892Z", "payloadSha256": "d73284772767cc139a11821e825c3b4b09d8a1a35182b6bc35672b68869b1005", "piiRedacted": true } ], "citation": { "canonicalId": "NCT07312513", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07312513", "verifyAt": "https://clinicaltrials.gov/study/NCT07312513", "retrievedAt": "2026-10-07T04:31:50.892Z", "payloadSha256": "d73284772767cc139a11821e825c3b4b09d8a1a35182b6bc35672b68869b1005", "text": "ClinicalTrials.gov, record NCT07312513 (https://clinicaltrials.gov/study/NCT07312513), retrieved 2026-10-07, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT07312513, registered in ClinicalTrials.gov, retrieved 2026-10-07. Verify at the source URLs listed; each retrieval is checksummed.", "note": "Only one registry is known to hold this trial. Absence from the others is not evidence it was not registered there." }, "provenanceNote": "Personal contact fields (names, emails, phone numbers, addresses) are stripped from every stored payload. No participant-level data is collected or served." }, "_meta": { "api": "The Last Economy Wire: World Trials API", "version": "1.0", "schemaVersion": "1", "correlationId": "req_p4VtDDeTZnbS", "generatedAt": "2026-10-30T22:26:48.254Z", "documentation": "https://negativeresistance.com/embed", "license": "Free for any use. Attribution appreciated.", "degraded": false, "provenance": { "sources": [ "clinicaltrials_gov" ], "attribution": { "clinicaltrials_gov": "ClinicalTrials.gov: licence: public-domain, https://clinicaltrials.gov/data-api/api-docs" }, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "limitations": [], "provenanceEndpoint": "/api/v1/sources" }, "freshness": { "newestEvidenceAt": null, "lastSyncedAt": { "clinicaltrials_gov": "2026-10-28T04:33:30.663Z" }, "degradedSources": [], "worldwide": false, "maxAgeHours": 65.9, "fromCache": false }, "links": { "discovery": "https://negativeresistance.com/api/v1", "openapi": "https://negativeresistance.com/api/v1/openapi.json", "mcp": "https://negativeresistance.com/api/v1/mcp", "agentCard": "https://negativeresistance.com/.well-known/agent.json", "aiPlugin": "https://negativeresistance.com/.well-known/ai-plugin.json", "sdk": "https://negativeresistance.com/api/v1/sdk", "status": "https://negativeresistance.com/api/v1/status", "provenance": "https://negativeresistance.com/api/v1/sources", "contract": "https://negativeresistance.com/api/v1/contract", "curriculum": "https://negativeresistance.com/api/v1/curriculum", "graph": "https://negativeresistance.com/api/v1/graph", "openQuestions": "https://negativeresistance.com/api/v1/open-questions", "scoreboard": "https://negativeresistance.com/api/v1/scoreboard", "findings": "https://negativeresistance.com/api/v1/findings", "claims": "https://negativeresistance.com/api/v1/claims", "threads": "https://negativeresistance.com/api/v1/threads", "assignment": "https://negativeresistance.com/api/v1/assignment", "changes": "https://negativeresistance.com/api/v1/changes", "hello": "https://negativeresistance.com/api/v1/hello", "errors": "https://negativeresistance.com/api/v1/errors", "webhooks": "https://negativeresistance.com/api/v1/webhooks", "a2a": "https://negativeresistance.com/api/v1/a2a", "deadEnds": "https://negativeresistance.com/api/v1/dead-ends", "decompositions": "https://negativeresistance.com/api/v1/decompositions", "rungs": "https://negativeresistance.com/api/v1/rungs", "methods": "https://negativeresistance.com/api/v1/methods", "reality": "https://negativeresistance.com/api/v1/reality", "council": "https://negativeresistance.com/api/v1/council", "calibration": "https://negativeresistance.com/api/v1/calibration", "freshness": "https://negativeresistance.com/api/v1/freshness", "mission": "https://negativeresistance.com/api/v1/mission", "twin": "https://negativeresistance.com/api/v1/twin", "twinExperiment": "https://negativeresistance.com/api/v1/twin/experiment", "betaCell": "https://negativeresistance.com/api/v1/twin/beta-cell", "patientModel": "https://negativeresistance.com/api/v1/twin/patient-model", "agentCardCanonical": "https://negativeresistance.com/.well-known/agent-card.json", "collaborate": "https://negativeresistance.com/collaborate", "manifesto": "https://negativeresistance.com/about", "documentation": "https://negativeresistance.com/embed", "connect": "https://negativeresistance.com/connect", "llmsTxt": "https://negativeresistance.com/llms.txt", "llmsFullTxt": "https://negativeresistance.com/llms-full.txt" }, "disclaimer": "Research data from public registries and literature; not medical advice." } }