Community leg ulcer bandaging study: lessons learned in a pilot, randomized controlled trial 

Area of Science:

• Vascular Medicine
• Clinical Trial Methodology
• Wound Care Research

Background:

• Compression therapy is vital for venous leg ulcers (VLUs), but comparative effectiveness data, particularly in home care settings, is scarce.
• A pilot randomized controlled trial (RCT) was conducted to evaluate the feasibility of the Canadian Bandaging Trial (CBT) protocol.

Purpose of the Study:

• To assess the practicality of the CBT study protocol, including screening, recruitment, randomization, intervention integration, data collection, and database management.
• To identify areas for improvement in the larger RCT design and execution.

Main Methods:

• A 6-month pilot RCT involving 12 VLU patients, 40 nurses, and two investigators at two community sites in Ontario, Canada.
• Participants were randomized to either a four-layer or short-stretch compression bandage.
• The Pilot Research Process Framework (PReP) guided the evaluation of study procedures.

Main Results:

• Eligibility screening and randomization procedures were efficient.
• A low screened-to-enrolled patient ratio (49:12) indicated a need for expanded recruitment strategies, including more clinical sites and adjusted eligibility criteria.
• Issues with screening practices, data collection forms, and wound photography were identified and addressed.

Conclusions:

• The pilot study successfully refined and streamlined the quality and processes for the main CBT RCT, underscoring the value of pilot research.
• Recommendations include increasing the number of clinical sites, modifying ulcer size eligibility criteria, and investigating the inclusion of diabetic patients in future leg ulcer trials.
• Further research is needed to validate the Pilot Research Process Framework (PReP) in other pilot studies.