Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds

Completed · Not applicable

Conditions studied: Chronic Wound, Venous Leg Ulcer, Diabetic Foot Ulcer

In brief

A prospective, randomized, controlled clinical trial (RCT) using a cross-over (repeated measures) design to evaluate safety and efficacy of three foam wound dressings in the local management of chronic wounds.

Key facts

Study ID

NCT03662997

Run by

Molnlycke Health Care AB

People needed

40

Starts

2019-03-19

Expected to finish

2019-11-15

Last updated by the study team

2021-04-01

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects 18-85 years of age with leg and foot ulcers (i.e. VLU, DFU).
• Signed informed consent.
• Subject and/or caregiver must be willing and able to tolerate multi-layered compression bandages when applicable and offloading footwear.
• Study subject must be available and able to visit the clinic weekly for the full 4-week period.

You may not qualify if…

• Pressure ulcers should not be included. Pressure injury as defined by the National Pressure Ulcer Advisory Panel (NPUAP).
• Presence of local wound infection as determined by study doctor based on clinical signs and symptoms.
• Subject has any evidence of peripheral arterial disease (PAD).
• Subject diagnosed with malignancy other than cutaneous basal cell carcinoma.
• Subject has received growth factor therapy (e.g. autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix e.g. amnion, amniotic tissue) within 2 weeks of screening date.
• Pregnancy or lactation at time of study participation.
• Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
• Subject is currently enrolled or participated in another investigational device, drug or biological trial within 30 days of baseline of this study.
• Present history of alcohol or drug abuse.
• Known allergy/hypersensitivity to any of the components of the dressing.
• Subject not suitable for the investigation according to the investigator's judgment.

Where it is running

• Center for Clinical Research, Inc. — Castro Valley, California, United States
• Center for Clinical Trials, Inc. — San Francisco, California, United States
• Vascular and Wound Care Center — Newark, New Jersey, United States
• SerenaGroup Research Foundation — Pittsburgh, Pennsylvania, United States
• SerenaGroup — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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