Evidence map›Paper›PMID 42847019›Full record

ArticlePatient related outcome measures2026

Patient-reported outcomes in venous leg ulcers: results from a prospective multicenter single-arm cohort study of silicone superabsorbent polymer dressings.

Sebastian Probst, Vladica Veličković, Jacek Mikosinski, Konrad Panczak, Adam Wegrzynowski, Dorota Piechota, Marek Kotala, Przemyslaw Lipinski, Katarzyna Rybolowicz, Agnieszka Lipinska and 6 more

Registry-linked trialAbstract read
In one paragraph

Article in Patient related outcome measures, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07549737 (A Prospective, Single-arm, Cohort Post Market Clinical Follow Up Investigation to Follow Evolution of the Healing of Exuding Chronic Leg Ulcers Treated With RespoSorb Silicone Border and RespoSorb Silicone Dressings.), which is not on this map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07549737 nacompletednot on this map

A Prospective, Single-arm, Cohort Post Market Clinical Follow Up Investigation to Follow Evolution of the Healing of Exuding Chronic Leg Ulcers Treated With RespoSorb Silicone Border and RespoSorb Silicone Dressings.

TypeinterventionalSponsorHARTMANN GROUPRan2024 to 2025Enrolled80ConditionsVenous Leg Ulcer (VLU), Diabetic Foot Ulcer (DFU)ArmsRespoSorb Silicone (RSSil), RespoSorb Silicone Border (RSSB)
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Sebastian ProbstGeneva School of Health Science, HES-SO, Switzerland.
Vladica VeličkovićEvidence Generation Department, HARTMANN GROUP, Germany.
Jacek MikosinskiGeneral and Vascular Surgery, Mikomed Sp. z o.o., Poland.
Konrad PanczakGeneral and Vascular Surgery, LECRAN-Centrum Opieki nad Ranami-Kunickiego, Poland.
Adam WegrzynowskiInternal Medicine, Podovia Sp. z o.o., Poland.
Dorota PiechotaInternal Medicine, JBS Klinika Sp. z o.o., Poland.
Marek KotalaVascular Surgery, MelissaMed Poradnia Chirurgiczna, Poland.
Przemyslaw LipinskiGeneral Surgery, NZOZ "ARGO" Centrum Medyczne, Poland.
Katarzyna RybolowiczGeneral Surgery, Specjalistyczny Ośrodek Leczniczo-Badawczy, Poland.
Agnieszka LipinskaGeneral Surgery, NZOZ "ARGO" Centrum Medyczne, Poland.
Jacek BilDepartment of Cardiology, National Medical Institute of the Ministry of Warsaw and Administration, Poland.
Teresa SzenkStatistics Department, Clean Data Labs, Poland.
Patrycja BuczakClinical Operations, Sphera Clinical Research, Poland.
Cornelia SantosoEvidence Generation Department, HARTMANN GROUP, Germany.
Anitha PitchikaEvidence Generation Department, HARTMANN GROUP, Germany.
David G ArmstrongKeck School of Medicine, University of Southern California, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Venous leg ulcers (VLUs) are chronic wounds associated with substantial symptom burden, impaired health-related quality of life, and high healthcare costs. Current guidance recommends assessing patient-centered outcomes alongside healing. This study reports the VLU subgroup of a prospective multicenter cohort, focusing on wound-related quality of life and patient-perceived treatment benefit. Methods: This prospective, single-arm cohort study was conducted in specialist wound centers in Poland. Adults with chronic, noninfected, exuding VLUs received RespoSorb Silicone Border or RespoSorb Silicone dressings together with standardized compression therapy for up to 6 weeks. Patient-reported outcomes (PRO) were the Wound Quality of Life questionnaire (Wound-QoL-17) and the Patient Benefit Index for wounds (PBI-W). Changes in Wound-QoL from baseline to final visit, responder analyses using the published 0.50-point minimal important difference and attained PBI-W scores at follow-up were analyzed. Results: Fifty-two patients with VLU were included (44.2% women; mean age 69.1 years). Final PRO data were available for 48 patients. Mean global Wound-QoL improved from 2.03 at baseline to 1.18 at final visit (mean change 0.81; 95% CI 0.49-1.12; Conclusions: Silicone superabsorbent polymer dressings used with compression were associated with improved quality of life and high patient-perceived benefit. Findings support incorporating validated patient-reported outcomes in VLU research and warrant larger comparative studies. Trial Registration: ClinicalTrials.gov Identifier NCT07549737 (Date of registration: 24.04.2026). Registration was completed retrospectively due to an administrative oversight during a transition in study leadership. The study protocol and prespecified study procedures were established before enrollment began, and the statistical analysis plan was finalized before database lock. No changes were made to the study objectives, endpoints, eligibility criteria, conduct, statistical analyses, or reporting as a result of the delayed registration.

Indexed as

outcomes researchpatient benefit indexpatient-reported outcomesquality of lifesilicone superabsorbent dressingVenous leg ulcerwound-QoL

Identifiers

PMID42847019
PMCPMC13644622

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