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Study protocol: A pilot clinical trial of topical glyceryl trinitrate for chronic venous leg ulcer healing
Miles, Sandra Lord, Roger Williams, D. Fulbrook, Paul
Miles, Sandra
Lord, Roger
Williams, D.
Fulbrook, Paul
Abstract
Background Chronic venous leg ulcers (VLUs) are costly to the healthcare system and a burden to patients, significantly reducing quality of life. Nitric oxide (NO) is important to wound healing, with a small study demonstrating a NO donor, topical glyceryl trinitrate (GTN), was effective for VLU healing. The aim of this study is to examine the application of topical GTN in relation to VLU healing.
Methods A pilot double-blinded randomised controlled clinical trial will be undertaken. Participants in the control group (n=20) will receive a placebo ointment (ointment base) and participants in the treatment group (n=20) will receive a NO donor (base ointment with 2% GTN) weekly for 4 weeks. The inclusion criteria will be adults >18 years of age with a chronic VLU. Rate of healing will be determined by planimetry (ulcer tracing) using the Gillman equation.
Significance This clinical trial aims to provide proof of concept of a novel treatment, topical GTN, which may accelerate wound healing through improvements to vasodilation and antimicrobial properties at the wound bed.
What is already known - Chronic VLUs are a burden to patients and the healthcare system.
- NO is important to wound healing.
- GTN is a NO donor.
What this study aims to contribute - Pilot a double-blind clinical trial of topical GTN.
- Examine the effect of 2% topical GTN on wound healing in VLUs.
Keywords
Glyceryl trinitrate, nitric oxide, venous leg ulcer, wound healing
Date
2019
Type
Journal article
Journal
Wound Practice & Research
Book
Volume
27
Issue
3
Page Range
131-134
Article Number
ACU Department
School of Nursing, Midwifery and Paramedicine
Faculty of Health Sciences
School of Behavioural and Health Sciences
Faculty of Health Sciences
School of Behavioural and Health Sciences
Relation URI
Event URL
Open Access Status
Published as ‘gold’ (paid) open access
License
File Access
Open
Open
Open