Restore Calcium Alginate Dressing, Silver vs Aquacel Ag in the Treatment of Critically Colonized Venous Leg Ulcers

Stopped early · Phase 4

Conditions studied: Venous Ulcer, Infection

In brief

Calcium alginate dressings with silver have been found to be safe and effective for use for leg ulcers. The primary objective is to compare Restore Calcium Alginate Dressing, Silver to AqualCel Ag Dressing on the following parameters: No further progression toward infection (bioburden), ease of application and removal, and percent progression to closure. The secondary objective is to obtain photographic documentation of the leg ulcers during the course of the study.

Key facts

Study ID

NCT01396304

Run by

Hollister Wound Care LLC

People needed

19

Starts

2011-10-01

Expected to finish

2013-02-01

Last updated by the study team

2013-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is 18 years or older; male or female.
• Previous diagnosis of venous insufficiency proven by a positive venous duplex with reflux.
• Has a venous ulcer with a wound area between 5 cm2 - 40 cm2.
• Has an ankle brachial index (ABI) >0.8.
• Has a venous ulcer with duration less than 24 months.
• Has a venous ulcer which is critically colonized (not infected) based on the Lazareth Study Model. Ulcers are considered to be critically colonized if at least three of the five following signs are present:
• Severe spontaneous pain between two dressing changes,Perilesional erythema,Local edema,Malodour,Heavy Exudation
• Is currently using Profore as their standard of care.
• Has not received antibiotics for 6 weeks prior to enrollment.

You may not qualify if…

• Has an allergy to one of the components of the dressings (calcium alginate, hydrocolloid [carboxymethylceullose], silver).
• Is currently on antibiotics.
• Has a negative venous duplex.
• Is unable to tolerate 4 layer compression.
• Is unable to continue contact with the investigator for a period of at least two weeks.
• Is unwilling or unable to comply with the study protocol.

Where it is running

• Palms of Pasadena Hospital — St. Petersburg, Florida, United States
• LSU Health Sciences Center — Shreveport, Louisiana, United States
• Bayshore Community Hospital — Holmdel, New Jersey, United States
• Wound Institute & Research Center — Dunmore, Pennsylvania, United States
• Lake Washington Vascular Surgeons — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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