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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01396304

Enrollment

Registered

2011-07-18

Start date

2011-10-31

Completion date

2013-02-28

Last updated

2013-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Venous Ulcer

Keywords

leg ulcer, infection, closure, wound dressings

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.

Interventions

DEVICERestore Calcium Alginate Dressing

Wound dressing appropriate for venous leg ulcers. Dressing to be changed minimally once per week.

DEVICEAquaCel Ag Wound Dressing

Wound dressing appropriate for venous leg ulcers. Dressing to be changed minimally once per week.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026