Chronic Wound CarePOLTX_FiberNCT07576322
Short-Term Safety and Performance of Two Wound Dressings Evaluation
A study testing Politix Fiber arm in people with Chronic Wound Care and Local Infection, run by Sebastian Probst at 3 sites in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Wound Care, Local Infection, Safety
- What is being tested?
- Politix Fiber arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 15 Jun 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland3 sites
Geneva University Hospitals
Geneva, Canton of Geneva, 1205
Damien Pastor, MD, 41223723311, damien.pastor@hug.ch
Lausanne University Hospital
Lausanne, Canton of Vaud, 1002
Lucie charbonneau, MSc, RN, 41213141111, lucie.charbonneau@chuv.ch
Instituions Hospital Du Nord Vaudois
Yverdon-les-Bains, Canton of Vaud, 1400
Carole Guex, RN, DAS in Wound Care, 412442424444, carole.guex@hesge.ch
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Chronic Wound Care, Local Infection, Safety
- Being tested
- Politix Fiber arm
- Keywords
- chronic wound, local infection prevention, wound exudate, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Politix Fiber armCombination 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).
| Study group | Role | What they receive |
|---|---|---|
| POLTX_Fiber arm | Experimental | POLTX_Fiber, an absorbent gelling fiber dressing for moderate-high exudate chronic wounds Receives: Combination Product: Politix Fiber arm |
| Suprasorb® Liquacel Pro, CE-marked gelling fiber dressing | No intervention | Suprasorb® Liquacel Pro arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photographic evaluation
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 >
Measured: 12 Weeks
Change in wound area
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.
Measured: 12 weeks
Secondary outcomes (8)
Wound healing progression
Wound healing progression over 12 weeks will be measured from pictures of the wound taken with ImitoWound
Measured: 12 weeks
Change in wound tissue composition
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.
Measured: 12 weeks
Local Infection Assessment
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.
Measured: 12 weeks
Global Tolerability Assessment
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).
Measured: 12 weeks
Pain (Visual Analogue Scale (VAS)
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.
Measured: 12 weeks
Exudate management
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.
Measured: 12 weeks
Frequency of dressing changes
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.
Measured: 12 weeks
Global Tolerability Assessment by participants
Patients will independently assess tolerability on a 3-point scale (Chandanwale 2014): 0 = No issues, 1 = Moderate, 2 = Poor.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start15 Jun 2026 (estimated)
- Primary completion14 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Wound CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Evaluate the clinical performance and safety of POLTX\_Fiber compared to Suprasorb® Liquacel Pro in an outpatient clinical setting
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sebastian Probst
- Sponsor type
- University, hospital or other
- Collaborators
- eHnv Hospital, University Hospital, Geneva, CHUV, Lausanne University Hospitals, Switzerland
- Responsible party
- Sponsor-investigator, Sebastian Probst, School of Health Sciences Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576322
- Sponsor's protocol ID
- POLTX_Fiber
- Other IDs
- Polaroid Therapeutics
- Acronym
- POLTX_Fiber
- Status last verified
- May 2026
- First submitted
- 23 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data will be shared using Yareta (https://yareta.unige.ch/home) a Swiss research platform using the FAIR priniples
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07576322
- Acronym / sponsor ID
- POLTX_Fiber / POLTX_Fiber
- Conditions
- Chronic Wound Care, Local Infection, Safety
- Keywords
- chronic wound, local infection prevention, wound exudate, safety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sebastian ProbstUniversity, hospital or other
- Collaborators
- eHnv Hospital, University Hospital, Geneva, CHUV, Lausanne University Hospitals, Switzerland
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 14 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Evaluate the clinical performance and safety of POLTX_Fiber compared to Suprasorb® Liquacel Pro in an outpatient clinical setting
| Arm | Type | Receives |
|---|---|---|
| POLTX_Fiber arm | Experimental | Combination Product: Politix Fiber armPOLTX_Fiber, an absorbent gelling fiber dressing for moderate-high exudate chronic wounds |
| Suprasorb® Liquacel Pro, CE-marked gelling fiber dressing | No intervention | –Suprasorb® Liquacel Pro arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Politix Fiber armPOLTX_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). | Combination product | POLTX_Fiber arm |
Primary outcome
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 >
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.
8 secondary outcomes
Wound healing progression
Time frame: 12 weeks
Change in wound tissue composition
Time frame: 12 weeks
Local Infection Assessment
Time frame: 12 weeks
Global Tolerability Assessment
Time frame: 12 weeks
Pain (Visual Analogue Scale (VAS)
Time frame: 12 weeks
Exudate management
Time frame: 12 weeks
Frequency of dressing changes
Time frame: 12 weeks
Global Tolerability Assessment by participants
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Yes. Raw data will be shared using Yareta (https://yareta.unige.ch/home) a Swiss research platform using the FAIR priniples
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Politix Fiber arm in people with Chronic Wound Care and Local Infection, run by Sebastian Probst at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Probst, Prof. Dr. (41 22-558-6563, sebastian.probst@hesge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Photographic evaluation (time frame: 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.