CompletedNot Applicable

VLU Dressing Study

United States31 participantsStarted 2018-08-22

Plain-language summary

The goal of the study is to investigate the effectiveness of Cutimed Sorbact (Study Device) in modifying bacterial load in venous leg ulcers (VLU).

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adults, 18 years old and older (i.e. age ≥ 18 years).
✓. Venous leg ulcer (VLU) is present on the leg. VLU shall be full thickness but without exposure of deeper tissues (muscle bone or tendon).
✓. If more than one ulcer is present, the largest ulcer meeting criteria shall be designated the study ulcer.
✓. If more than one ulcer on the study ulcer limb, study ulcer shall be at least one centimeter from other ulcers.
✓. Venous Doppler ultrasound exam, within one year from randomization, shall demonstrate reflux of over 0.5 seconds in the affected limb.
✓. Ankle-Brachial Pressure Index (ABI) exam with value of ≥0.80 in the affected limb
✓. VLU has been treated with silver based therapy for at least 2 weeks within the previous 6 months.
✓. VLU present for at least one month prior to screening visit 1.

✕. Based on investigator medical judgment, ulcer is caused by any etiology exclusive of venous insufficiency.
✕. Study Ulcer surface area (post-debridement) has increased or decreased by more than 30% in the period between screening visit 1 and treatment visit 1.
✕. Study Ulcer exhibits clinical signs and symptoms of infection in the period between screening visit 1 and treatment visit 1 requiring oral antibacterial therapy.
✕. Subject has known allergy to any of the materials used in the study.
✕. Subject is unable to tolerate multi-layer compression therapy.
✕. Based on investigator medical judgment, the Study Ulcer is suspicious for cancer (e.g. basal cell carcinoma or squamous cell carcinoma).
✕. In the month prior to screening visit 1 subject was treated with systemic immunosuppressive medications for more than 2 weeks (e.g. chemotherapy, corticosteroids), and/or it is anticipated subject will require such medications during study period.
✕. In the month prior to screening visit 1 subject was enrolled in any other research protocol for treatment of Study Ulcer.

Change in Bacterial Load

Timeframe: Baseline, Up to 8 weeks

NCT IDNCT03621592

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-01

Results submitted2025-06-04

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adults, 18 years old and older (i.e. age ≥ 18 years).
✓. Venous leg ulcer (VLU) is present on the leg. VLU shall be full thickness but without exposure of deeper tissues (muscle bone or tendon).
✓. If more than one ulcer is present, the largest ulcer meeting criteria shall be designated the study ulcer.
✓. If more than one ulcer on the study ulcer limb, study ulcer shall be at least one centimeter from other ulcers.
✓. Venous Doppler ultrasound exam, within one year from randomization, shall demonstrate reflux of over 0.5 seconds in the affected limb.
✓. Ankle-Brachial Pressure Index (ABI) exam with value of ≥0.80 in the affected limb
✓. VLU has been treated with silver based therapy for at least 2 weeks within the previous 6 months.
✓. VLU present for at least one month prior to screening visit 1.

✕. Based on investigator medical judgment, ulcer is caused by any etiology exclusive of venous insufficiency.
✕. Study Ulcer surface area (post-debridement) has increased or decreased by more than 30% in the period between screening visit 1 and treatment visit 1.
✕. Study Ulcer exhibits clinical signs and symptoms of infection in the period between screening visit 1 and treatment visit 1 requiring oral antibacterial therapy.
✕. Subject has known allergy to any of the materials used in the study.
✕. Subject is unable to tolerate multi-layer compression therapy.
✕. Based on investigator medical judgment, the Study Ulcer is suspicious for cancer (e.g. basal cell carcinoma or squamous cell carcinoma).
✕. In the month prior to screening visit 1 subject was treated with systemic immunosuppressive medications for more than 2 weeks (e.g. chemotherapy, corticosteroids), and/or it is anticipated subject will require such medications during study period.
✕. In the month prior to screening visit 1 subject was enrolled in any other research protocol for treatment of Study Ulcer.