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Short-Term Safety and Performance of Two Wound Dressings Evaluation (POLTX_Fiber)

4. mai 2026 oppdatert av: Sebastian Probst

A Post-Market Clinical Follow-Up Study to Evaluate Short-Term Safety and Performance of POLTX_Fiber Compared With Suprasorb Liquacel Pro in Chronic Wounds

Chronic wounds, including venous leg ulcers, diabetic foot ulcers, and pressure ulcers, are defined as wounds that fail to heal within 4-8 weeks despite appropriate care. They represent a significant health burden due to prolonged healing, risk of infection, recurrence, and impact on quality of life and healthcare costs. Their development is multifactorial and often linked to vascular impairments, which reduce oxygen and nutrient supply. This leads to impaired tissue repair, persistent inflammation, and increased susceptibility to infection.

Standard treatment includes wound debridement, infection control, maintaining a moist environment, and managing pain and exudate. POLTX_Fiber is an absorbent gelling fiber dressing designed to improve moisture balance, manage exudate, and reduce bacterial load, with established safety and CE marking.

A post-market clinical follow-up study will compare POLTX_Fiber with Suprasorb® Liquacel Pro over a 30-day period in an outpatient setting. The study evaluates wound healing, infection status, usability, pain, and patient satisfaction. It is conducted in accordance with EU and Swiss regulations, ensures qualified investigators, and considers sex and gender differences in the analysis.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Chronic wounds, including venous leg ulcers, diabetic foot ulcers, and pressure ulcers, represent a growing healthcare burden, associated with delayed healing, high recurrence rates, and reduced quality of life. Their pathophysiology is multifactorial, involving impaired perfusion, dysregulated inflammation, and bacterial colonization, all of which contribute to prolonged healing.

Effective wound management requires control of exudate, maintenance of a moist wound environment, and management of microbial burden. Absorbent gelling fiber dressings are commonly used for this purpose; however, comparative clinical evidence between available products remains limited.

POLTX_Fiber is a CE-marked absorbent gelling fiber dressing intended to support exudate management and wound healing. Additional clinical data are needed to further evaluate its performance under routine clinical conditions, in line with post-market clinical follow-up (PMCF) requirements under Regulation (EU) 2017/745.

This study aims to evaluate the clinical performance and safety of POLTX_Fiber in patients with chronic wounds in an outpatient setting, compared with a standard gelling fiber dressing. The primary objective is to assess changes in wound surface area over a 30-day treatment period. Secondary objectives include evaluation of wound condition, patient outcomes, and device usability.

This is a multicenter, non-randomized, controlled, open-label PMCF study conducted in outpatient care. Eligible patients will receive either POLTX_Fiber or a comparator dressing as part of routine clinical practice.

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Sveits
    • Canton of Geneva
      • Geneva, Canton of Geneva, Sveits, 1205
        • Geneva University Hospitals
        • Ta kontakt med:
    • Canton of Vaud
      • Lausanne, Canton of Vaud, Sveits, 1002
        • Lausanne University Hospital
        • Ta kontakt med:
      • Yverdon-les-Bains, Canton of Vaud, Sveits, 1400
        • Instituions Hospital Du Nord Vaudois
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

Age ≥ 18 years Chronic wound of 4 weeks to 2 years in duration Moderate to highly exuding wound (clinician-assessed) Wound area 2-50 cm² after debridement Able and willing to provide informed consent and comply with study procedures

Exclusion Criteria:

Known hypersensitivity to study or comparator dressing components Clinically infected wound requiring systemic antibiotics at baseline Necrotic wound (>25% necrotic tissue) or malignant wound Severe arterial insufficiency (ABI < 0.5) Pregnant or breastfeeding Severe comorbid condition likely to interfere with wound healing or safety evaluation (e.g., end-stage renal disease, active cancer on chemotherapy, immunosuppression) Participation in another interventional study within 30 days Use of investigational wound products within 30 days Cognitive or psychiatric condition limiting consent or compliance Unable to attend follow-up visits or likely to relocate during the study period Any condition that, in the investigator's judgment, may compromise safety or study integrity

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: POLTX_Fiber arm
POLTX_Fiber, an absorbent gelling fiber dressing for moderate-high exudate chronic wounds
Kombinasjonsprodukt: Politix Fiber arm

POLTX_Fiber, an absorbent gelling fiber dressing for moderate-high exudate chronic wounds, applied strictly per IFU and local protocol.

Application workflow (per visit). It will proceed as follows:

  • Removal of old dressing.
  • Application of analgesic if necessary (timed to peak during debridement/dressing).
  • Debridement if necessary (sharp/hydrolytic per local practice; document method/date).
  • Wound cleansing (sterile 0.9% saline or Ringer's; no antiseptics) (IWII 2025).
  • Application of a suitable secondary dressing according to wound phase and medical prescription to secure the primary and maintain moisture balance.
  • Compression therapy for venous disease according to the standardized procedure described in Section 6.1; apply off-loading for DFU per local SOP where indicated.
  • Documentation in the eCRF (Imito Wound® digital photographs/planimetry, tissue composition, exudate character, TILI infection score, VAS pain, any device deficiencies).
Ingen inngripen: Suprasorb® Liquacel Pro, CE-marked gelling fiber dressing
Suprasorb® Liquacel Pro arm

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Photographic evaluation
Tidsramme: 12 Weeks

Standardized photographs will be obtained using ImitoWound® after dressing removal, wound debridement (if applicable) and wound cleansing at a frequency of no more than once per week, even if multiple dressing changes take place during the same week. ImitoWound® will be used in an iPad as instructed in supplier's wound imaging and measurement guidelines. The camera of the iPad will be maintained 20 to 30 cm away from and parallel to the wound. A calibration marker (quick response [QR] code) will be positioned next to and in the same plane of the wound, and a photograph will be taken after recognition of the QR code by ImitoWound®, providing automatic wound measurements. This marker will allow standardised image captures maintaining fixed distance, lighting, and calibration.

Study nurses will receive concise training and a working instruction with step-by-step procedure on how to use ImitoWound®. Images will be anonymized and centrally reviewed by two blinded assessors; discrepancies >
12 Weeks
Change in wound area
Tidsramme: 12 weeks

Wound area (length, width, depth, area) will be recorded using ImitoWound®. Percent wound area reduction (PWAR) from baseline to EoT (Day 30) or follow-up (Week 8 and Week 12) will be computed automatically using the following formula:

PWAR = [(Wound area at baseline - Wound area at follow-up) / Wound area at baseline] × 100.

Higher percentages indicate faster healing. Where digital imaging is unavailable, manual planimetry measurements may be used and documented.
12 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Wound healing progression
Tidsramme: 12 weeks
Wound healing progression over 12 weeks will be measured from pictures of the wound taken with ImitoWound
12 weeks
Change in wound tissue composition
Tidsramme: 12 weeks
Change from baseline in wound tissue composition, as assessed using digital wound assessment technology. Tissue composition (e.g. granulation, slough, necrosis) will be determined automatically through ImitoWound® image analysis at baseline and when wound images are captured during wound care. Results will be expressed as a percentage of total wound area (sum = 100%), enabling consistent quantification of healing dynamics over time.
12 weeks
Local Infection Assessment
Tidsramme: 12 weeks

Local infection will be evaluated at each visit using the Therapeutic Index for Local Infection (TILI), a validated clinical tool for early infection detection (erythema, peri-wound oedema, malodour, exudate change, pain).

A TILI score ≥ 5 indicates clinically relevant infection requiring medical evaluation or treatment adjustment.
12 weeks
Global Tolerability Assessment
Tidsramme: 12 weeks
Usability of POLTX_Fiber will be assessed using a short Investigator Usability and Handling Questionnaire based on ISO 14155:2020 and FDA Human Factors guidance (2016). Parameters include ease of application/removal, dressing integrity, handling characteristics, and overall satisfaction. Rated on a 5-point Likert scale (Total score ranges from 5 to 22).
12 weeks
Pain (Visual Analogue Scale (VAS)
Tidsramme: 12 weeks
Pain will be recorded at each dressing change using a 10-cm VAS (0 = no pain, 10 = worst pain imaginable). Pain on application, during wear, and on removal will be documented.
12 weeks
Exudate management
Tidsramme: 12 weeks

Assessment of characteristics of wound exudate In addition to color and odor of wound exudate will be recorded using simplified Keast (2022) descriptors:

  • Color: serous (clear/amber), serosanguinous (pink), purulent (opaque/yellow/green).
  • Odor: absent, faint, moderate, strong. Abrupt increases in volume or the emergence of purulent/strongly malodorous exudate will trigger reassessment of the TILI Score and clinical review to rule out infection.
12 weeks
Frequency of dressing changes
Tidsramme: 12 weeks

The total number of dressing changes (scheduled and unscheduled) during the thirty-day treatment will be recorded in the eCRF. Each entry will include:

  • Date and time of change
  • Reason (e.g., exudate saturation, leakage, odor, clinical judgement)
  • Dressing type (POLTX_Fiber vs SoC)
  • Cumulative dressing count Participants will be categorized as ≤2 changes/week, 3-4 changes/week, or ≥5 changes/week. Lower dressing-change frequency indicates better absorbency and longer wear time.
12 weeks
Global Tolerability Assessment by participants
Tidsramme: 12 weeks
Patients will independently assess tolerability on a 3-point scale (Chandanwale 2014): 0 = No issues, 1 = Moderate, 2 = Poor.
12 weeks

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sociodemographic and diagnostic data
Tidsramme: Baseline

At Screening, investigators will collect the following information and record it in the electronic Case Report Form (eCRF):

  • Sociodemographic data (age, sex, occupation, level of mobility, living situation).
  • Relevant comorbidities (e.g., diabetes, peripheral vascular disease, venous insufficiency).
  • Current medications or topical wound treatments.
  • Lifestyle factors (smoking and alcohol use).
Baseline
Wound etiology
Tidsramme: Baseline
At Baseline, wound etiology (e.g., venous leg ulcer, diabetic foot ulcer, pressure ulcer) will be documented
Baseline
Wound anatonical location
Tidsramme: Baseline
Wound anatomical location will be documented at baseline
Baseline
Wound diagnostic classification
Tidsramme: Baseline
Wound diagnostic classification (if applicable, e.g., Wagner grade for diabetic ulcers or EPUAP stage for pressure ulcers).
Baseline

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sebastian Probst

Samarbeidspartnere

University Hospital, Geneva
eHnv Hospital
CHUV, Lausanne University Hospitals, Switzerland

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. juni 2026

Primær fullføring (Antatt)

14. juni 2027

Studiet fullført (Antatt)

30. september 2027

Datoer for studieregistrering

Først innsendt

23. april 2026

Først innsendt som oppfylte QC-kriteriene

4. mai 2026

Først lagt ut (Faktiske)

8. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • POLTX_Fiber
  • Polaroid Therapeutics (Annen identifikator: Polaroid Therapeutics)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Raw data will be shared using Yareta (https://yareta.unige.ch/home) a Swiss research platform using the FAIR priniples

IPD-delingstidsramme

from 2028 until 2029

Tilgangskriterier for IPD-deling

all researchers

IPD-deling Støtteinformasjonstype

  • ANALYTIC_CODE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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