Evaluation of glyceryl trinitrate ointment as treatment for leg ulcers

Phase 1

Recruiting

• Conditions: Chronic venous leg ulcers; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Skin - Other skin conditions; Inflammatory and Immune System - Connective tissue diseases

• Registration Number: ACTRN12616000520437
• Lead Sponsor: The Prince Charles Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-21
• Last Update Posted: 16 March 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

transdermal oxygen sensors will not be used. Clinical judgement will be used.
This investigation seeks to recruit consenting patients with venous leg ulceration from the internal medicine wards of the Prince Charles Hospital (TPCH). Venous ulceration will be confirmed by clinical judgement and patient notes and/or confirmation by medical and/or podiatry team. This is to rule out ulceration by other aetiologies (i.e. arterial, pressure, diabetic) which have been shown in earlier studies to not benefit from GTN application (data not published).

Patients recruited into this study will be informed that their participation in this trial is entirely voluntary and no financial payment will be given. If patients decide to not take part in this study, there will be no prejudice against their future care and are free to withdraw at any time. Consenting patients will then be randomly allocated to one of two groups (placebo versus GTN treatment).

Exclusion Criteria

Patients must have venous ulceration. Additionally, patients with malignant ulcers or have other forms of malignancy will be excluded from the study together with any patient who has active autoimmune disease or have had organ transplantation. Patients with acute exacerbation of cardiac disease may be excluded from treatment with GTN as the product may lower blood pressure. Those with ongoing / active cardiac disease will be included.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The trial will run only for 4 weeks so rates of healing will be determined by planimetry (ulcer tracing) using computer software for this purpose (PicZar).Complete healing of the ulcer will most likely not be achieved in the time frame being examined. If a statistically significant difference exists between the two groups the treatment will deemed successful. It is hoped that a subsequent larger trial will be planned based on the findings from this pilot clinical trial. The trial is therefore a proof of concept trial before larger Phase 2 trials begin.[Four weeks after treatment (i.e. Each participant will be treated weekly for 4 weeks).]

Secondary Outcome Measures

Name	Time	Method
il[Nil]