Suprasorb®X+PHMB Pro vs Suprasorb®X+PHMB in Treatment of Infected Venous Leg Ulcers

NCT07211243 | Recruiting

• 1 other identifier: 2024-07
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 9

Brief Summary

This clinical investigation will be conducted as a multicentre, open-label, randomised in parallel groups, controlled study on patients with infected venous leg ulcers.

Conditions

Venous Leg Ulcer

Keywords

maceration; bacterial cellulose dressing; PHMB; antimicrobial dressing

Outcome Measures

Primary Outcomes (1)

• Rate and severity of maceration after 3 weeks of treatment with Suprasorb®X+PHMB (Pro)

  on a 4-grade scale there 0 means no maceration and 4 means severe maceration

  3 weeks

Secondary Outcomes (10)

• Wound area change over time

  3 weeks

• Change of necrotic & fibrinous & granulation tissue rate in the wound bed

  3 weeks

• Change of wound infection status

  3 weeks

• Product safety (rate of product-related complications)

  3 weeks

• Change of wound exudation and presence of peri-wound oedema

  3 weeks

Study Arms (2)

Suprasorb®X+PHMB Pro

EXPERIMENTAL

Patients will receive the assigned wound dressing for 21 (±2) days, or till the complete epithelialization, if it occurs earlier. The patients should also receive adequate compression and, if necessary, systemic antimicrobial drug therapy.

Device: PHMB-impregnated biocellulose wound dressing with additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional)

Suprasorb®X+PHMB

ACTIVE COMPARATOR

Patients will receive the assigned wound dressing for 21 (±2) days, or till the complete epithelialization, if it occurs earlier. The patients should also receive adequate compression and, if necessary, systemic antimicrobial drug therapy.

Device: PHMB-impregnated biocellulose wound dressing without additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional)

Interventions

PHMB-impregnated biocellulose wound dressing with additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional) DEVICE

Application of a wound dressing with additional polyethylene film on top and compression therapy. Optional usage of the systemic antimicrobial therapy.

Suprasorb®X+PHMB Pro

PHMB-impregnated biocellulose wound dressing without additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional) DEVICE

Application of a wound dressing without additional polyethylene film on top and compression therapy. Optional usage of the systemic antimicrobial therapy.

Suprasorb®X+PHMB

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Infected\* venous\*\* leg ulcer
• Slightly to moderately exuding wound\*\*\*
• Patient has signed informed consent
• as per CDC definition, also TILI score ≥ 5 \*\* ABPI \> 0.8 and \< 1.2 \*\*\* patients with highly exuding wounds may be screened for a 7 days run-in period to receive superabsorbent dressing and monitored compression therapy and re-con-sidered for enrolment in case the exudation level decreases

You may not qualify if:

• Participation in other interventional clinical trial that could interfere with the present study within 4 weeks of the randomisation and during the whole duration of this study
• Wounds with exposed cartilage tissue (hyaline cartilage)
• Contraindications to compression therapy (e.g.: advanced peripheral ar-terial occlusive diseases, decompensated cardiac insufficiency, septic phlebitis, phlegmasia coerulea dolens, sensation disorders of the skin)
• Known allergy and/or hypersensitivity to any components of the study product or concomitant products (e.g. compression bandage)
• Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and / or interpreta-tion of the study results.

Sponsors & Collaborators

• Lohmann & Rauscher: lead
• Clean Data Labs: collaborator
• Sphera Clinical Research: collaborator

Study Sites (9)

ClinicMed Daniluk, Nowak Spółka Komandytowa OŚRODEK LECZENIA RAN i Owrzodzeń

Bialystok, 15-879, Poland

RECRUITING

Centrum Medyczne Ultramed

Krakow, Poland

WITHDRAWN

MelissaMed Poradnia Chirurgiczna

Lodz, Poland

WITHDRAWN

Mikomed Spółka Z Ograniczoną Odpowiedzialnością

Lodz, Poland

RECRUITING

Niepubliczny Zakład Opieki Zdrowotnej "Argo" Centrum Medyczne

Lodz, Poland

RECRUITING

PP CLINIC Pietrzyk spółka partnerska lekarzy

Lublin, Poland

RECRUITING

SPECJALISTYCZNY OSRODEK LECZNICZO BADAWCZY, Zbigniew Żęgota

Ostróda, Poland

RECRUITING

Lecran - Centrum Opieki Nad Ranami-Kunickiego

Wroclaw, Poland

RECRUITING

Specjalistyczna Pomoc Medyczna "Medservice"

Zabrze, Poland

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Konrad Pańczak, MD

  LECRAN - CENTRUM OPIEKI NAD RANAMI-KUNICKIEGO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daria Trofimenko, MD

CONTACT

02631996385; daria.trofimenko@de.lrmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Primary endpoint ans some secondary endpoints will be re-confirmed by a blinded assessment of the wound photographs
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be randomised to Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB in a 1:1 ratio.

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: October 7, 2025
• Study Start: September 23, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): June 15, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (9)