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HM242-Solution vs Comparator

NCT04902612 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2021-11-22

No results posted yet for this study

Summary

The objectives of this study include investigating the performance of HM242-Solution compared to normal Saline with respect to venous leg ulcer healing. Saline is widely used for venous leg ulcer cleansing and has served as comparator or standard treatment in clinical trials evaluating new cleansing products to prove that it is as good as the standard treatment. Data will also be collected on the patients' quality of life and any adverse events that may arise during the study.

Conditions

  • Venous Leg Ulcer

Interventions

DEVICE

HM242-Solution

HM242-Solution compared to Saline compared in patients with a venous leg ulcer

DEVICE

Saline

HM242-Solution compared to Saline compared in patients with a venous leg ulcer

Sponsors & Collaborators

  • B. Braun Ltd. Centre of Excellence Infection Control

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-25
Primary Completion
2022-10-31
Completion
2022-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04902612 on ClinicalTrials.gov