Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

The management of chronic wounds in the community is a pressing issue for home care authorities. The care of leg ulcers represents a considerable expense to the health care system. It has been estimated that the care of venous leg ulcers alone consumes 1% of the national health care budgets of the UK and France. A one-month prevalence study in the Ottawa Carleton region (pop. 750,000) revealed that 126 Community Care Access Centre Clients (CCAC - the regional health care authority) received over 1500 home nursing visits. During the course of a year this represents more than $600,000 in home nursing visits for this condition in just one Ontario region. There is evidence supporting effective wound management but this is not necessarily what patients receive. As well, appropriate evidence-based, efficient, community-based care must be supported by ready access to specialized facilities. Research from other countries suggest that reorganization of services which includes nurse-run clinic care near to home, evidence-based protocols, and enhanced linkages with secondary and tertiary services may result in improvements in healing rates and reductions in expenditures. These international studies provide optimism that with reorganization of care within the Canadian context we can deliver community services for improved outcomes. However, only with a rigorous evaluation of the effectiveness and efficiency can we understand if such changes in the Canadian context are beneficial.

Objective:

To evaluate the effectiveness and efficiency of two models of service delivery: traditional single service delivery model (home visiting) compared to nurse-led community clinics.

Research Questions:

1. What are the health outcomes (healing, function, plain and quality of life) for two models of care (nurse-run neighbourhood clinics vs. home care) for the population with leg ulcers?

2. What are health services utilization and expenditures associated with the two models of care?

3. What is client and provider satisfaction with the nurse-run neighbourhood clinics and home nursing care?

4. What are the barriers and supports to implementing neighbourhood leg ulcer clinics?

Study Design and Method:

A randomized health services controlled trial of nurse-run neighbourhood leg ulcer clinics (intervention) and home care (current practice) with a cost-effectiveness analysis. A repeated measures design will be used to assess healing and ulcer improvement, quality of life and patient satisfaction over time.

Outcome measures:

The primary outcome measure is the proportion of limbs healed by three months. Secondary outcome measures are: time to complete healing, ulcer size, ulcer recurrence, function, pain, quality of life, client and provider satisfaction. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00656383
Study type Interventional
Source Queen's University
Contact
Status Completed
Phase N/A
Start date October 2000
Completion date March 2005

See also
  Status Clinical Trial Phase
Withdrawn NCT02561013 - A Clinical Study to Assess a Compression Device in Patients With Venous Leg Ulcers N/A
Recruiting NCT05364112 - Utilization of Compreflex Wraps in Patients With Chronic Venous Insuffciency N/A
Active, not recruiting NCT02973893 - Study of VF001-DP in Patients With Chronic Venous Leg Ulcers Phase 2
Not yet recruiting NCT02873728 - Remote Ischemic Conditioning for Treatment of Chronic Wounds N/A
Completed NCT01998932 - Predictive of Biomarkers of Healing in Chronic Venous Ulceration of the Lower Limb N/A
Recruiting NCT06135246 - Laser Therapy for Venous Leg Ulcers N/A
Active, not recruiting NCT03744858 - The Role of Pyroptosis in Chronic Venous Disease
Completed NCT01449422 - Clinical Trial to Evaluate the Efficacy, Tolerance and Acceptability of URGO Dressing vs a Hydrofibre in the Local Management of Venous or Predominantly Venous Mixed Leg Ulcers. Phase 4
Completed NCT00838500 - THERMES ET VEINES: Spa for Prevention of Leg Ulcers Phase 3
Completed NCT04039789 - Impact of Physical Activity as a Coadjuvant Treatment in the Healing of Venous Ulcers in Primary Health Care. N/A
Completed NCT04280679 - Treatment of Insufficient Superficial and Perforatring Veins of the Lower Limb Using HIFU N/A
Completed NCT02512159 - Skin Ulcers Treatment With an Handicraft Topical Device Phase 4
Completed NCT02896725 - Wool-derived Keratin Dressings for Venous Leg Ulcers N/A
Completed NCT04310280 - Effects of Local Insulin on Varicose Ulcers for Wound Healing Phase 3
Completed NCT02626156 - Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence Phase 2
Recruiting NCT03127904 - Vein Fitness System vs Compressive Therapy for Venous Ulcers: a Bayesian Adaptive Trial N/A
Withdrawn NCT00648674 - A Post-Marketing Clinical Study of Apligraf for Venous Leg Ulcers Phase 4
Terminated NCT00727701 - Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development Phase 1
Completed NCT00399308 - Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers Phase 1/Phase 2
Completed NCT00426972 - Trial of Zesteem (Estradiol) in Healing of Split Thickness Skin Graft Donor Sites Phase 3