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

Phase 4

Terminated

• Conditions: Venous Ulcer; Infection
• Interventions: Device: Restore Calcium Alginate Dressing; Device: AquaCel Ag Wound Dressing

• Registration Number: NCT01396304
• Lead Sponsor: Hollister Wound Care LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-14
• Study First Submitted QC: 2011-07-15
• Study First Posted: 2011-07-18
• Study Start: 2011-10
• Status Verified: 2013-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Last Update Submitted: 2013-02-12
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

1. Is 18 years or older; male or female.

2. Previous diagnosis of venous insufficiency proven by a positive venous duplex with reflux.

3. Has a venous ulcer with a wound area between 5 cm2 - 40 cm2.

4. Has an ankle brachial index (ABI) >0.8.

5. Has a venous ulcer with duration less than 24 months.

6. 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

7. Is currently using Profore as their standard of care.

8. Has not received antibiotics for 6 weeks prior to enrollment.

Exclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restore Calcium Alginate Dressing Silver	Restore Calcium Alginate Dressing	Restore Calcium Alginate Dressing Silver under compression wrap
Aquacel Ag Wound Dressing	AquaCel Ag Wound Dressing	Aquacel Ag Wound Dressing under compression wrap

Primary Outcome Measures

Name	Time	Method
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.	Observations will be collected over 6 weeks for a total of 7 visits

Secondary Outcome Measures

Name	Time	Method
The secondary objective is to obtain photographic documentation of the venous leg ulcers during the course of the study.	Observations will be collected over 6 weeks in a total of 7 visits.

Trial Locations

Locations (5)

Lake Washington Vascular Surgeons; 🇺🇸 Bellevue, Washington, United States

Wound Institute & Research Center; 🇺🇸 Dunmore, Pennsylvania, United States

Bayshore Community Hospital; 🇺🇸 Holmdel, New Jersey, United States

Palms of Pasadena Hospital; 🇺🇸 St. Petersburg, Florida, United States

LSU Health Sciences Center; 🇺🇸 Shreveport, Louisiana, United States