Randomiseret dobbeltblindet forsøg på sikkerhed og effektivitet af Nanordica Advanced antibakteriel sårforbinding til diabetisk fodsår (NM2023)
Et randomiseret, dobbeltblindt, aktivt kontrolleret, parallel gruppe klinisk forsøg for at vurdere sikkerheden og effektiviteten af Nanordica antibakteriel sårforbinding hos patienter med DFU'er
This clinical trial evaluates the safety and efficacy of the Nanordica Advanced Antibacterial Wound Dressing (AAWD) in patients suffering from diabetic foot ulcers. At least 136 participants will be randomly allocated to be treated either with AAWD or Aquacel Ag+ Extra wound dressing for a 4-week active phase (intervention) followed by an 8-week standard of care period.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Harju
-
Tallinn, Harju, Estland
- East Tallinn Central Hospital
-
Tallinn, Harju, Estland
- North Estonia Medical Centre Foundation
-
-
Tartu
-
Tartu, Tartu, Estland
- Tartu University Hospital
-
-
-
-
-
Madrid, Spanien
- Hospital Ramón y Cajal
-
Madrid, Spanien
- Hospital Universitario Fundación Alcorcón
-
San Sebastián, Spanien
- Hospital Universitario de Donostia
-
-
Cádiz
-
Arcos de la Frontera, Cádiz, Spanien
- Centro de Salud de Arcos de la Frontera
-
Cadiz, Cádiz, Spanien
- Hospital Puerta del Mar
-
Jerez de la Frontera, Cádiz, Spanien
- Centro de Salud San Benito
-
-
León
-
León, León, Spanien
- Hospital de León
-
-
Madrid
-
Madrid, Madrid, Spanien
- Clínica Universitaria de Podología de la Universidad Complutense de Madrid
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Voluntary, written informed consent obtained prior to any study related activities.
- Males and females aged ≥18 years.
- DFU(s) present for more than 4 weeks with a maximum diameter of 4 cm.
- IWGDF/IDSA Wound infection grades 1 (absent) or 2.
- Patients willing and able to comply with scheduled visits, laboratory sampling and study procedures.
- Ankle-brachial index (ABI) 0.9-1.4 or ABI between 0.6-0.9 with ankle pressure ≥ 70 mmHg.
Exclusion Criteria:
- Ssystemic or topical antibiotic therapy within 7 days before the enrolment.
- Any wound with known associated osteomyelitis or positive probe-to-bone test.
- Previous randomization in this clinical trial.
- Surgical procedures in the same leg as the index ulcer(s) (e.g., radical debridement, ulcerectomy, skin grafting, exostectomy, amputation) within the past four weeks, or planned to during the study.
- Use of other advanced therapies directly involving the index ulcer(s) (e.g. skin substitutes, matrices, cellbased therapies or products) within the past four weeks.
- Patients suffering cardiac disorders grade NYHA IV.
- Patients suffering hepatic disorders grade Child-Pugh C.
- Stage 4 cancer.
- Women of childbearing potential who are pregnant, breast-feeding or not using adequate contraceptive methods.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Avanceret antibakteriel sårforbinding
|
For the first 4 weeks, wound dressing will be changed twice weekly. Subsequently, dressing selection and change frequency will be managed by the investigator as part of the standard of care for another 8 weeks. |
|
Aktiv komparator: Aquacel Ag+ Extra
|
For the first 4 weeks, wound dressing will be changed twice weekly. Subsequently, dressing selection and change frequency will be managed by the investigator as part of the standard of care for another 8 weeks. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Composite Wound Healing Response at 12 weeks
Tidsramme: 12 weeks
|
Composite Wound Healing Response (CWHR) defined as either a wound area reduction (WAR) of more than 50% at 4 weeks relative to baseline (WAR50/4) and/or complete wound closure (CWC) at 12 weeks (CWC/12) |
12 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Wound area reduction at 4 weeks
Tidsramme: 4 weeks
|
Wound area reduction at 4 weeks expressed as percent change from baseline measured using the transparent film method |
4 weeks
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Adverse events
Tidsramme: 12 weeks
|
Number and severity of adverse events |
12 weeks
|
|
CWC at 12 weeks
Tidsramme: 12 weeks
|
Complete wound closure at 12 weeks |
12 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NM2023
- CIV-ES-24-10-049337 (Anden identifikator: EUDAMED)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .