NCT01396304

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

1.3 years

First QC Date

July 14, 2011

Last Update Submit

February 12, 2013

Conditions

Venous UlcerInfection

Keywords

leg ulcerinfectionclosurewound dressings

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Study Arms (2)

Restore Calcium Alginate Dressing Silver

EXPERIMENTAL

Restore Calcium Alginate Dressing Silver under compression wrap

Device: Restore Calcium Alginate Dressing

Aquacel Ag Wound Dressing

ACTIVE COMPARATOR

Aquacel Ag Wound Dressing under compression wrap

Device: AquaCel Ag Wound Dressing

Interventions

Restore Calcium Alginate DressingDEVICE

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

Restore Calcium Alginate Dressing Silver
AquaCel Ag Wound DressingDEVICE

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

Aquacel Ag Wound Dressing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Palms of Pasadena Hospital

St. Petersburg, Florida, 33707, United States

Location

LSU Health Sciences Center

Shreveport, Louisiana, 71103, United States

Location

Bayshore Community Hospital

Holmdel, New Jersey, 07733, United States

Location

Wound Institute & Research Center

Dunmore, Pennsylvania, 18512, United States

Location

Lake Washington Vascular Surgeons

Bellevue, Washington, 98004, United States

Location

MeSH Terms

Conditions

Varicose UlcerInfectionsLeg Ulcer

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Rita Kaurs, MSHSA MT NMT

    Hollister Incorporated

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2011

First Posted

July 18, 2011

Study Start

October 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

US(5)