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

2026年5月4日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

60

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • スイス
    • Canton of Geneva
      • Geneva、Canton of Geneva、スイス、1205
        • Geneva University Hospitals
        • コンタクト：
    • Canton of Vaud
      • Lausanne、Canton of Vaud、スイス、1002
        • Lausanne University Hospital
        • コンタクト：
      • Yverdon-les-Bains、Canton of Vaud、スイス、1400
        • Instituions Hospital Du Nord Vaudois
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：非ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：POLTX_Fiber arm
POLTX_Fiber, an absorbent gelling fiber dressing for moderate-high exudate chronic wounds
組み合わせ製品：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).
介入なし：Suprasorb® Liquacel Pro, CE-marked gelling fiber dressing
Suprasorb® Liquacel Pro arm

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Photographic evaluation
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Wound healing progression
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：12 weeks
Patients will independently assess tolerability on a 3-point scale (Chandanwale 2014): 0 = No issues, 1 = Moderate, 2 = Poor.
12 weeks

その他の成果指標

結果測定
メジャーの説明
時間枠
Sociodemographic and diagnostic data
時間枠：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
時間枠：Baseline
At Baseline, wound etiology (e.g., venous leg ulcer, diabetic foot ulcer, pressure ulcer) will be documented
Baseline
Wound anatonical location
時間枠：Baseline
Wound anatomical location will be documented at baseline
Baseline
Wound diagnostic classification
時間枠：Baseline
Wound diagnostic classification (if applicable, e.g., Wagner grade for diabetic ulcers or EPUAP stage for pressure ulcers).
Baseline

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Sebastian Probst

協力者

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

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月15日

一次修了 (推定)

2027年6月14日

研究の完了 (推定)

2027年9月30日

試験登録日

最初に提出

2026年4月23日

QC基準を満たした最初の提出物

2026年5月4日

最初の投稿 (実際)

2026年5月8日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月8日

QC基準を満たした最後の更新が送信されました

2026年5月4日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • POLTX_Fiber
  • Polaroid Therapeutics (その他の識別子：Polaroid Therapeutics)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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

IPD 共有時間枠

from 2028 until 2029

IPD 共有アクセス基準

all researchers

IPD 共有サポート情報タイプ

  • ANALYTIC_CODE

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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