What is this study trying to find out about venous leg ulcers?

This study is evaluating how well two different superabsorbent dressings manage wound fluid in venous leg ulcers. Researchers want to see which dressing better absorbs exudate and prevents skin damage, helping to improve wound care. The study is sponsored by BSN Medical GmbH and aims to provide useful information for routine treatment.

Who may be eligible for this venous leg ulcer clinical trial?

Adults aged 18 or older with a venous leg ulcer on the lower leg or ankle, lasting between 4 weeks and 1 year, may be eligible. Participants must be able to follow the study visits and agree to standard therapies like compression. Both men and women can join. Please review eligibility criteria for more details.

Is there any cost to participate in this venous leg ulcer clinical trial?

Study-related care, including the study dressings and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06300762

Comparing Exudate Absorption of Cutimed Sorbion and Zetuvit Superabsorbent Dressings for Venous Leg Ulcers

Led by BSN Medical GmbH · Updated on 2025-01-31

152

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to compare the fluid absorption performance of two commonly used CE-marked superabsorbent dressings in people with venous leg ulcers VLUs. The study focuses on how well each dressing manages wound exudate, prevents skin maceration, and avoids leakage, which are important factors for promoting wound healing during routine care. Participants will be randomly assigned to use either the Cutimed Sorbion product range or the Zetuvit RespoSorb product range for managing exudate from their VLUs. Both product groups include various dressing types designed to absorb wound fluid. The study will last up to 30 days, during which participants will receive regular dressing changes and wound care. Throughout the study, participants will attend scheduled visits for assessments including the frequency of dressing changes, skin condition around the wound, wound tissue changes, pain levels, and patient and healthcare provider satisfaction. Quality of life will be measured using a specific questionnaire at the start and end of the study. Safety and wound healing progress will be closely monitored over the 30-day period.

CONDITIONS

Brief Title

RCT Exudate Management Cutimed Sorbion Product Range

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Participant is informed about the trial, understands the study, and provides written consent before enrollment
Participant is mentally and physically able to participate
Men, women, and diverse individuals aged 18 years or older
Participant agrees to comply with study visits and standard therapies like compression
Participant has a lower leg ulcer (including ankle but not feet) needing treatment with the study device
Ulcer duration is between 4 weeks and 1 year
Ulcer size ranges from 2 cm² to 800 cm²
One side of the ulcer does not extend beyond 40 cm
Ulcer depth is less than 2 cm
Ankle-brachial pressure index (ABPI) is between 0.8 and 1.3, measured within the past 12 months
Only one ulcer per participant will be included

You will not qualify if you...

Participant already enrolled in this study with one ulcer
Participant unlikely or unwilling to follow study requirements
Presence of systemic infectious diseases affecting healing, such as AIDS
Undergoing immuno-compromising therapy like systemic antineoplastic drugs or corticosteroids
Using medication that may delay wound healing
Employed by the hospital or sponsor or in a dependent relationship with staff
Pregnant or breastfeeding
Alcohol or drug addiction or substitution therapy (e.g., Methadone)
Enrolled in another clinical trial with medical devices or drugs within past 30 days
History of sensitivity to any study product components
Ulcer is clinically infected or malignant
Ulcer requires negative pressure wound therapy or hyperbaric oxygen during the trial
Ulcer exposes bone, tendon, ligaments, or joint
History of radiation at ulcer site
Lesion is primary skin cancer or metastasis manifestation

Research Team

Hardy Schweigel, PhD

Sandra Tobisch

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