Effectiveness of Silicone Superabsorbent Polymer Dressings for Chronic Wound Management

NCT07549737 | Completed

• 1 other identifier: PHAG-EVO-CH
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this single arm clinical study is to find out how well two Silicone superabsorbent polymer dressings, RespoSorb Silicone (also known as Zetuvit Plus Silicone) and RespoSorb Silicone Border (also known as Zetuvit Plus Silicone Border), work in treating long lasting wounds on the lower legs or feet. The main goal of the study is to see whether these dressings help reduce wound size over time. The study also looks at whether the dressings improve the condition of the wound and the surrounding skin. In addition, patients are asked about their experience with the dressings, including whether they help reduce pain and how satisfied patients are with the treatment.

Conditions

Diabetic Foot Ulcer (DFU); Venous Leg Ulcer (VLU)

Keywords

Venous leg ulcer; Diabetic Foot Ulcer; Silicone superabsorbent dressings

Outcome Measures

Primary Outcomes (1)

• Wound area reduction

  Clinical effectiveness will be assessed by the change in wound area of the target ulcer over time. Wound area will be calculated in square centimeters (cm²) using planimetric analysis based on standardized digital photographs taken at each study visit. The study has established a threshold for clinical significance, defining a minimum reduction in the wound area of 20%.

  Up to 6 weeks (maximum total treatment period), or until wound healing, withdrawal, or discontinuation, whichever occurs first

Secondary Outcomes (18)

• Change in granulation tissue over time

  Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first

• Change in Slough Tissue Over Time

  Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first

• Change in Exudate Amount Over Time

  Weekly assessments during the treatment period, up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first.

• Change in Exudate Type Over Time

  Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first

• Improvement of Peri-Wound Skin Condition Over Time

  Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first.

Other Outcomes (3)

• Frequency of Dressing Changes

  Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first

• Device-Related Adverse Events and Device Deficiencies

  Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first

• Healthcare professional assessment of ease of use, comfort of use and practical experience with the dressings

  After the end of treatment for the patient at 6 weeks or or until wound healing, withdrawal, or discontinuation, whichever occurs first

Study Arms (1)

Silicone SAP Dressings (RespoSorb Silicone / RespoSorb Silicone Border)

EXPERIMENTAL

Single-arm cohort of adult patients with chronic, exuding lower extremity wounds treated with Silicone SAP dressings. Participants receive either RespoSorb Silicone or RespoSorb Silicone Border, selected based on wound characteristics and clinical judgement, and are followed prospectively to assess wound area reduction, wound-bed condition, patient-reported outcomes, and safety.

Device: RespoSorb Silicone (RSSil); Device: RespoSorb Silicone Border (RSSB)

Interventions

RespoSorb Silicone (RSSil) DEVICE

RespoSorb Silicone is a Silicone Superabsorbent Polymer (SAP) dressing intended for the management of chronic, exuding lower extremity wounds. The dressing consists of a superabsorbent core designed to absorb and retain wound exudate and a soft silicone contact layer that allows gentle adhesion to the peri-wound skin while minimizing trauma and pain during dressing changes. RespoSorb Silicone is applied directly to the wound bed and secured with an appropriate secondary fixation according to standard clinical practice and the manufacturer's Instructions for Use. Dressing changes are performed as clinically indicated. Treatment is continued for up to 6 weeks or until wound healing, discontinuation, or withdrawal.

Also known as: Zetuvit Plus Silicone

Silicone SAP Dressings (RespoSorb Silicone / RespoSorb Silicone Border)

RespoSorb Silicone Border (RSSB) DEVICE

RespoSorb Silicone Border is a Silicone Superabsorbent Polymer (SAP) dressing intended for the management of chronic, exuding lower extremity wounds. The dressing combines a superabsorbent core for effective exudate absorption and retention with a soft silicone contact layer to minimize disruption of the wound and peri-wound skin. The dressing includes an integrated adhesive silicone border that provides secure fixation without the need for additional secondary dressings. RespoSorb Silicone Border is applied according to standard clinical practice and the manufacturer's Instructions for Use. Dressing changes are performed as clinically indicated. Treatment is continued for up to 6 weeks or until wound healing, discontinuation, or withdrawal.

Also known as: Zetuvit Plus Silicone Border

Silicone SAP Dressings (RespoSorb Silicone / RespoSorb Silicone Border)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is 18 years of age or older and has given formal written consent.
• Diagnosed with a chronic, exuding lower extremity wound of a single limb:
• Venous leg ulcer (VLU) or
• Diabetic Foot Ulcer (DFU).
• Target ulcer persists since min. 1 and max. 12 months prior to screening.
• An appropriate dressing size is available to be used according to the size of the target ulcer, the ulcer size shall be no longer than 10 cm in one dimension.
• Target ulcer is not clinically infected ( Clinically infected wound is defined as a wound that required the use of systemic antibiotics or topical antimicrobials ).
• Ankle-brachial pressure index (ABPI) is between 0.8 and 1.2 measured during the Screening or within 30 days prior to the Screening Visit. If ABPI is \>1.2 the Toe-Brachial Index (TBI) should be \>0.6.
• Presence of an ulcer extending through the full thickness of the skin but not down to muscle, tendon or bone.
• For VLU: Patient is able to walk in conjunction to compression therapy. Ankle mobility is fully mobile to limited mobile.
• For DFU: Patient is suitable and agrees to use offloading devises for the study duration.
• For DFU: Patient is able to walk in conjunction to offloading devices. Ankle mobility is fully mobile to limited mobile.

You may not qualify if:

• Known allergies/hypersensitivity or intolerance to any of the study product ingredients.
• Patients with ischemic diabetic foot ulcers.
• Patients with more than two full-thickness lower extremity ulcers on the same limb or greater than a total of three full-thickness lower-extremity ulcers.
• Target ulcer is clinically infected according to the judgement of HCP or suspected to be clinically infected that could require systemic antibiotics at the time of screening or during the study.
• Treatment with local or systemic antimicrobial therapy within 7 days prior to Screening visit or during the study duration.
• According to physician's assessment, the patient is not able to follow the study protocol (e.g. due to cognitive disease) or is not able to understand state, nature, meaning and consequences of the study.
• Patient suffers from active autoimmune disease requiring corticosteroid treatment (\> 10 mg prednisolone equivalent/day) and/or other immunosuppressive (e.g. cyclosporine (\>10mg/kg), methotrexate (\>10mg/week), TNF inhibitors (e.g. infliximab) and/ or chemotherapy within 7 days prior to Screening visit or during the study duration.
• Application of topical steroids to the ulcer surface 7 days prior to treatment or during the course of the study.
• Hyperbaric treatment 7 days prior to treatment or during the course of the study.
• Bioengineered tissue product usage on the target ulcer four weeks prior to treatment or during the course of the study.
• Patients with clinically significant intermittent claudication (the symptoms significantly impact a person's ability to walk and perform daily activities).
• Patients where the full dimensions of their leg ulcer could not be measured (it must be possible to display the entire wound area on one photo from a distance of 25-30 cm).
• Wound is caused by malign tumor (primary or metastasis). Any malignancy within the past three years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases.
• History of radiation to the target ulcer site within 12 months prior to screening.
• Patients with known history of having Acquired Immunodeficiency Syndrome (AIDS) or with a history known to be infected with Human Immunodeficiency Virus (HIV).

Sponsors & Collaborators

• HARTMANN GROUP: lead

Study Sites (8)

JBS Klinika Spółka Z Ograniczoną Odpowiedzialnością

Gdansk, Poland

Location

MelissaMed Poradnia Chirurgiczna

Lodz, Poland

Location

MIKOMED Spółka Z Ograniczoną Odpowiedzialnością

Lodz, Poland

Location

Niepubliczny Zakład Opieki Zdrowotnej "Argo" Centrum Medyczne

Lodz, Poland

Location

Specjalistyczny Osrodek Leczniczo Badawczy, Zbigniew Żęgota

Ostróda, Poland

Location

PODOVIA Sp. z o.o.

Poznan, Poland

Location

Niepubliczny Specjalistyczny Zakład Opieki Zdrowotnej "Medicus", Poradnia Chirurgiczna

Środa Wielkopolska, Poland

Location

Lecran - Centrum Opieki Nad Ranami-Kunickiego

Wroclaw, Poland

Location

MeSH Terms

Conditions

Varicose Ulcer; Diabetic Foot

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Foot Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 24, 2026
• Study Start: July 17, 2024
• Primary Completion: August 21, 2025
• Study Completion: August 23, 2025
• Last Updated: April 24, 2026

Record last verified: 2026-03

Locations

PL (8)