Community RCT of the Effectiveness of Two Compression Bandaging Technologies

Venous Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00202267
• Other study ID #: MCT 63175
• Secondary ID: 394622
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2005
• Last updated: November 18, 2015
• Start date: January 2004
• Est. completion date: December 2008

Study information

• Verified date: November 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: December 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Varicose Ulcer
• Venous Ulcer

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Nursing Practice Solutions	Fort Erie	Ontario
Canada	VON Hamilton Branch	Hamilton	Ontario
Canada	Kingston Chronic Wound Clinic	Kingston	Ontario
Canada	ParaMed Health Services	Kingston	Ontario
Canada	Saint Elizabeth Health Care	Kingston	Ontario
Canada	ET Now	Kitchener	Ontario
Canada	Carefor	Ottawa	Ontario
Canada	ParaMed Health Services	Ottawa	Ontario
Canada	Ostomy and Wound Care Centre	Regina	Saskatchewan
Canada	Saskatoon Health Region Home Care	Saskatoon	Saskatchewan
Canada	St. Joseph's Care Group	Thunder Bay	Ontario
Canada	Comcare Health	Toronto	Ontario
Canada	ParaMed Home Health Care	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Winnipeg Regional Health Authority	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	4 weeks or greater improvement in time-to-healing with short-stretch bandages compared to the four-layer bandaging system		Time to healing or up to 12 months; post-healing follow-up	No
Secondary	rate of reduction in ulcer area		Baseline and time of healing	No
Secondary	quality of life		Baseline and every 3 months	No
Secondary	expenditures over a one-year follow-up		From baseline to time of healing	No
Secondary	Recurrence		Status recorded at last visit of each month; one year post-healing follow-up	No

External Links

•   Canadian Institutes of Health Research
•   Cochrane Library systematic review: Compression for preventing recurrence of venous leg ulcers
•   Practice and Research in Nursing Group, Queen's University