NCT00656383

Brief Summary

Individuals referred to home care for leg ulcer management were randomized to nurse home visits (usual care) or nurse-run community clinics (intervention). The primary outcome will be the time to healing rates at three months. Secondary outcomes are: time to healing of all ulcers within the 12 month follow-up period, time to first recurrence of a healed ulcer, the number of weeks patients were free from ulcers, function, pain, and health related quality of life, client and provider satisfaction. We hypothesize that nurse-run neighborhood clinics result in better healing rates, more cost-effective care, and improved client and provider satisfaction than the home visiting model.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
401

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2008

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

3.4 years

First QC Date

April 7, 2008

Last Update Submit

November 18, 2015

Conditions

Varicose Ulcer

Keywords

venous ulcer, leg ulcer, stasis ulcer

Outcome Measures

Primary Outcomes (1)

  • Proportion in each study arm of ulcerated limbs completely healed at 3 months

    3 months

Secondary Outcomes (4)

  • Time to complete healing, ulcer size, and ulcer recurrence over 12 months

    12 months

  • Client function, pain and health-related quality of life

    12 months

  • Client and provider satisfaction

    12 months

  • Health services expenditure and utilization

    12 months

Study Arms (2)

1

ACTIVE COMPARATOR

Client is randomized to receive leg ulcer treatment in the home

Other: Clients receive leg ulcer care in their homes

2

ACTIVE COMPARATOR

Client randomized to receive leg ulcer care in the clinic

Other: Clients randomized to nurse-led clinic

Interventions

Clients randomized to nurse-led clinicOTHER

Clients receive leg ulcer care in a nurse-led clinic; both groups are treated by the same health care providers using the same protocol

Also known as: Usual Care, Best Practice, Venous Leg Ulcer treatment
2
Clients receive leg ulcer care in their homesOTHER

Clients receive leg ulcer care in at home; both groups are treated by the same health care providers using the same protocol

Also known as: Leg Ulcer Care, Usual Care, Best Practice
1

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The client:
  • Admission to home care for care of a venous leg ulcer (below the knee to the foot)
  • Ability to travel to clinic
  • No major contraindication for clinic care (eg not being able to leave an ill spouse, refusal, etc.)

You may not qualify if:

  • Treatment is contraindicated
  • The ulcer in question is not venous
  • The client cannot travel outside the home or travel is impeded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ottawa Carleton Community Care Access Centre

Ottawa, Ontario, K1J 7T2, Canada

Location

Victorian Order of Nurses, Ottawa-Carleton

Ottawa, Ontario, K1K 3B8, Canada

Location

Related Publications (1)

  • Harrison MB, Graham ID, Lorimer K, Vandenkerkhof E, Buchanan M, Wells PS, Brandys T, Pierscianowski T. Nurse clinic versus home delivery of evidence-based community leg ulcer care: a randomized health services trial. BMC Health Serv Res. 2008 Nov 26;8:243. doi: 10.1186/1472-6963-8-243.

    PMID: 19036149DERIVED

MeSH Terms

Conditions

Varicose UlcerLeg Ulcer

Interventions

Practice Guidelines as Topic

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Guidelines as TopicQuality Assurance, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Margaret B Harrison, RN, PhD

    The Ottawa Hospital

    PRINCIPAL INVESTIGATOR

  • Ian D Graham, PhD

    Clinical Epidemiology Unit, Ottawa Hospital-Civic Campus

    STUDY DIRECTOR

  • Philip S Wells, PhD

    The Ottawa Hospital

    STUDY DIRECTOR

  • Susan VanDeVelde, PhD

    Victorian Order of Nurses, Ottawa-Carleton Branch

    STUDY DIRECTOR

  • Judith L Threinen, BSR, MHA

    Ottawa-Carleton Community Care Access Centre

    STUDY DIRECTOR

  • Donna I Nicholson, Dip O&A

    Ottawa Carleton Community Care Access Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 7, 2008

First Posted

April 11, 2008

Study Start

October 1, 2000

Primary Completion

March 1, 2004

Study Completion

March 1, 2005

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

CA(2)