Community RCT of the Effectiveness of Two Compression Bandaging Technologies

November 18, 2015 updated by: Dr. Margaret Harrison, Queen's University

Community Randomised Control Trial of the Effectiveness of Two Compression Bandaging Technologies

Leg ulcers are emotionally distressing and painful, and often require months or years to heal. Although rarely acknowledged as a pressing health care issue, leg ulcers comprise a common, complex, and costly condition, managed primarily through community home care services. Indeed, leg ulcers are the most frequently seen and treated chronic wound. There is consensus in recent international, evidence-based practice guidelines that graduated, multi-layer compression is the most effective treatment, and greatly reduces healing time. High compression is more effective than low compression. However, there is no clear evidence as to which high compression technology is the most effective in promoting healing, the most acceptable to patients, or the most cost-effective to the health care system. This study is designed to answer these questions through a randomized trial conducted in the community, where most leg ulcer care currently takes place. Issues such as effectiveness in healing, quality of life, physical discomfort, personal preference, cost to the system and to the individual will be taken into consideration in evaluating two most commonly used types of compression bandaging.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:

Although rarely recognized as a pressing health care problem, leg ulcers comprise a common, complex, and costly condition. Over 80% of ongoing management of chronic wounds occurs in the community, and leg ulcers are one of the most frequently seen chronic wounds. The cost of leg ulcer care is considerable, being reported in both the UK and France to account for 2% of their total national health budgets. In Canada, the impact is only now being recognized due to the pressure on home care caseloads resulting from hospital downsizing, nursing shortages, and growing numbers of complex health populations. In one Ontario study, the care for fewer than 200 community leg ulcer cases cost in excess of $1.5 million for supplies and nursing visits, which translates to $100s of millions yearly Canada-wide. The impact on the individual is significant--chronic, painful, and often takes years to heal. Two-thirds of individuals with leg ulcers have at least one recurrence, and 45% have a history with the condition dating back 10 years.

State of Knowledge & Clinical Practice Guidelines:

Over the past decade, evidence from RCT studies and a recent Cochrane systematic review in BMJ demonstrated that venous leg ulcers treated with compression therapy are more likely to heal. Multi-layer high compression systems are more effective than low compression. However, the small number of people in trials comparing different high compression systems meant the review was unable to draw conclusions about their relative merit. Four of these trials have compared 4-layer bandage with short stretch technologies--the most commonly used technologies in Canada. In total, these trials involved only 220 patients, and were thus underpowered. Furthermore, they did not consider factors such as client preference and ease of use, or incorporate an economic evaluation.

Plan of Investigation:

The study will be a multi-centre, pragmatic, randomised trial of two types of compression bandaging technologies, incorporating an economic evaluation.

Research objective: To compare the effectiveness of 2 high compression technologies delivered in the community on ulcer healing, recurrence rates, quality of life, and cost-effectiveness.

Interventions: Four-layer bandage vs. Short-stretch bandage. Sample size: 414 total, 207 in each arm (80% power, " 0.05 to detect 4 week difference in time to heal).

Inclusion Criteria: leg ulcer>1 cm in any one dimension, minimum duration of 1 week, ABPI>0.7.

Randomization: will be carried out and stratified by: Clinical Centre (3 Health Regions in Ontario); Margolis' Prognostic Model (ulcer area and duration), Ulcer episode (1st or recurrent ulcer).

Analysis: Primary outcome: time-to-healing of the reference ulcer.

Secondary outcomes: quality of life & expenditures for treatment. Durability of healing will be assessed-follow-up for up to 52 weeks post-healing to determine recurrence rates associated with both technologies.

Summary:

There is consensus internationally in recommending the application of graduated multi-layer compression. High compression is more effective than low compression; however, there is no clear evidence as to which high compression technology is more effective.

Study Type

Interventional

Enrollment (Actual)

426

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3G 0N6
        • Winnipeg Regional Health Authority
    • Ontario
      • Fort Erie, Ontario, Canada, L2A 2G4
        • Nursing Practice Solutions
      • Hamilton, Ontario, Canada, L8L 5G8
        • VON Hamilton Branch
      • Kingston, Ontario, Canada, K7L 1G8
        • Saint Elizabeth Health Care
      • Kingston, Ontario, Canada, K7L 5E4
        • Kingston Chronic Wound Clinic
      • Kingston, Ontario, Canada, K7M 8R1
        • ParaMed Health Services
      • Kitchener, Ontario, Canada, N2H 3K5
        • ET Now
      • Ottawa, Ontario, Canada, K1K 3B8
        • Carefor
      • Ottawa, Ontario, Canada, K1Z 6X3
        • ParaMed Health Services
      • Thunder Bay, Ontario, Canada, P7B 5G7
        • St. Joseph's Care Group
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M5G 1V2
        • ParaMed Home Health Care
      • Toronto, Ontario, Canada, M5S 2T9
        • Comcare Health
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4S 0S4
        • Ostomy and Wound Care Centre
      • Saskatoon, Saskatchewan, Canada, S7H 4W3
        • Saskatoon Health Region Home Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinical presentation of venous insufficiency
  • leg ulcer equal to or larger than 0.7 cm in any one dimension
  • ulcer a minimum duration of 1 week
  • ankle brachial pressure index equal to or greater than 0.80
  • participant can provide written consent
  • participant can communicate in English, or translation available
  • participant 18 years or over

Exclusion Criteria:

  • diagnosed with Diabetes Mellitus - insulin dependent or participant on oral hypoglycemics
  • participants who failed to improve over a 3-month period after being treated with either the SS or 4-layer compression bandaging system prior to the trial
  • previous trial patients (ie individuals previously enrolled in the study but now have recurrence or a new ulcer)
  • symptoms of cognitive impairment noted

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Clients randomized to short-stretch bandaging application
Device: Short-stretch Bandage (Non-elastomeric)
These bandages are applied in a figure-eight technique; two bandages are applied at full extension in opposite directions up the leg (i.e., clockwise and counter clockwise). The participant will wash the short-stretch wherever possible and reused. The number of bandages supplied to each patient will be recorded on the visit record.
Other Names:
  • Comprilan (Beiersdorf-Jobst, Inc.)
ACTIVE_COMPARATOR: 2
Clients randomized to four-layer bandaging application
Device: Four-layer Bandage (Elastomeric)
Precise components of the four-layer system depend on the circumference of the ankle. All the bandages are discarded after a single use, usually one week.
Other Names:
  • Profore bandaging system (Smith & Nephew Medical Ltd.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
4 weeks or greater improvement in time-to-healing with short-stretch bandages compared to the four-layer bandaging system
Time Frame: Time to healing or up to 12 months; post-healing follow-up
Time to healing or up to 12 months; post-healing follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
rate of reduction in ulcer area
Time Frame: Baseline and time of healing
Baseline and time of healing
quality of life
Time Frame: Baseline and every 3 months
Baseline and every 3 months
expenditures over a one-year follow-up
Time Frame: From baseline to time of healing
From baseline to time of healing
Recurrence
Time Frame: Status recorded at last visit of each month; one year post-healing follow-up
Status recorded at last visit of each month; one year post-healing follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Margaret B Harrison, PhD, Queen's University
  • Principal Investigator: Ian D Graham, PhD, University of Ottawa (co-investigator)
  • Study Director: Elizabeth A Nelson, PhD, University of Leeds, UK (co-investigator)
  • Study Director: Karen Lorimer, MNSc, Victorian Order of Nurses (co-investigator)
  • Study Director: Connie Harris, MNSc, ET NOW (co-investigator)
  • Study Director: Elizabeth VanDenKerkhof, PhD, School of Nursing, Queen's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (ACTUAL)

March 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (ESTIMATE)

September 20, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

November 20, 2015

Last Update Submitted That Met QC Criteria

November 18, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCT 63175
  • 394622

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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