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NCT Number: NCT07576322

Short-Term Safety and Performance of Two Wound Dressings Evaluation

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.

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Key information

Conditions

Chronic Wound Care Local Infection Safety

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geneva University Hospitals, Geneva, Canton of Geneva, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Politix Fiber arm

Combination Product

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).

Primary outcomes

  1. Photographic evaluation

    Time frame: 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 >

  2. Change in wound area

    Time frame: 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.

Secondary outcomes

  1. Wound healing progression

    Time frame: 12 weeks

    Wound healing progression over 12 weeks will be measured from pictures of the wound taken with ImitoWound

  2. Change in wound tissue composition

    Time frame: 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.

  3. Local Infection Assessment

    Time frame: 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.

  4. Global Tolerability Assessment

    Time frame: 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).

  5. Pain (Visual Analogue Scale (VAS)

    Time frame: 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.

  6. Exudate management

    Time frame: 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.

  7. Frequency of dressing changes

    Time frame: 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.

  8. Global Tolerability Assessment by participants

    Time frame: 12 weeks

    Patients will independently assess tolerability on a 3-point scale (Chandanwale 2014): 0 = No issues, 1 = Moderate, 2 = Poor.

Other outcomes

  1. Sociodemographic and diagnostic data

    Time frame: 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).

  2. Wound etiology

    Time frame: Baseline

    At Baseline, wound etiology (e.g., venous leg ulcer, diabetic foot ulcer, pressure ulcer) will be documented

  3. Wound anatonical location

    Time frame: Baseline

    Wound anatomical location will be documented at baseline

  4. Wound diagnostic classification

    Time frame: Baseline

    Wound diagnostic classification (if applicable, e.g., Wagner grade for diabetic ulcers or EPUAP stage for pressure ulcers).

Study contacts

Contact information is provided by the study sponsor or research team.

André Frei, MSc

CONTACT

[email protected]

41 22-558-6050

Sebastian Probst, Prof. Dr.

CONTACT

[email protected]

41 22-558-6563

Sponsors and collaborators

Lead sponsor

Sebastian Probst

Other

Collaborators

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

Registry information

Official study title

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

Acronym: POLTX_Fiber

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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