NCT03621592

VLU Dressing Study

Completed NA Results posted Last updated 26 August 2025

What this trial tests

NA trial testing Cutimed® Sorbact® in Venous Leg Ulcer in 31 participants. Completed in 1 November 2023.

Timeline

22 August 2018

Primary endpoint
1 November 2023

1 November 2023

Quick facts

Lead sponsor	University of Miami
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	31
Start date	22 August 2018
Primary completion	1 November 2023
Estimated completion	1 November 2023
Sites	1 location across United States

Drugs / interventions tested

• Cutimed® Sorbact®
• Acticoat®

Conditions studied

• Venous Leg Ulcer — all drugs for Venous Leg Ulcer →

Sponsor

University of Miami

Who can join

18 and older, any sex, with Venous Leg Ulcer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Bacterial Load Primary · Baseline, Up to 8 weeks

Mean change in bacterial load in Colony Forming Units (CFU)/grams will be assessed from tissue samples

Group	Value	95% CI
Cutimed® Sorbact®	12678.81	± 23698.6
Acticoat®	33190.8	± 57882.61

Wound Healing Rate Secondary · Up 6 weeks

Wound healing rate (in cm\^2/week) will be calculated by measuring the wound area

Group	Value	95% CI
Cutimed® Sorbact®	.179	± .272
Acticoat®	.122	± .258

Percentage of Subjects With Complete Healing Secondary · Up to 8 weeks

The percentage of subjects achieving complete healing of ulcer at the evaluation of treating physician will be reported

Group	Value	95% CI
Cutimed® Sorbact®	20
Acticoat®	0

Pain as Measured by VAS Scores Secondary · Up to 8 weeks

The Pain Visual Analog Scale (VAS) has range from 0 (no pain) to 100 (worst possible pain). Mean change in scores will be reported from last visit compared to baseline will be reported.

Group	Value	95% CI
Cutimed® Sorbact®	.43	± 34.9
Acticoat®	-16.9	± 18.9

Wound Quality of Life (WQoL) Scores Secondary · Up to 8 weeks

WQoL is a 17 item questionnaire with each question scored on a 5 point scale, where 0 is "not at all" and 5 is "very much". WQoL has a total score ranging from 0 to 85 with a lower score indicating better quality of life. Mean change in scores will be reported from last visit compared to baseline will be reported.

Group	Value	95% CI
Cutimed® Sorbact®	-9.1	± 14.5
Acticoat®	-4.1	± 11.1

EQ-5D-5L Quality of Life Scores Secondary · Up to 8 weeks

The Euro Quality of life-5-Dimension-5-Level (EQ-5D-5L) is averaged based off the 5 point scale, where 0 is "no problems" and 5 is "extreme problems". Difference in scores will be reported from last visit compared to baseline will be reported.

Group	Value	95% CI
Cutimed® Sorbact®	0.12	± 0.23
Acticoat®	0.08	± 0.13

Number of Adverse Events Secondary · Up to 8 weeks

As assessed by treating physician

Group	Value	95% CI
Cutimed® Sorbact®	3
Acticoat®	2

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 8 weeks from start date. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cutimed® Sorbact®

Serious: 0/15 (0%)

Deaths: 0/15

Acticoat®

Serious: 0/16 (0%)

Deaths: 0/16

Other adverse events (2 terms — click to expand)

Reaction	System	Cutimed® Sorbact®	Acticoat®
Cutaneous infection	Skin and subcutaneous tissue disorders	—	—
Malignancy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—

Data from ClinicalTrials.gov NCT03621592 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.