A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers

Study Overview
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Brief Summary
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This study is for subjects with a venous leg ulcer. The study is being done to determine if NEXAGON plus compression bandaging is more effective that placebo plus compression bandaging.

Official Title
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A Randomized, Parallel Group, Dose-Ranging, Controlled, Multi-Center Study to Assess the Efficacy and Safety of Nexagon® in the Treatment of Subjects With a Venous Leg Ulcer

Conditions
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Venous Leg Ulcers

Intervention / Treatment
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* Drug: Nexagon® Low Dose
* Drug: Nexagon® High Dose
* Drug: Nexagon® Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of venous leg ulceration supported by venous duplex ultrasonography demonstrating venous reflux > 0.5 seconds Ankle brachial index of > 0.80 Venous Leg Ulcer (VLU) area greater than 2 cm2 and less than 20 cm2 Compliant with and able to tolerate high compression bandaging VLU present for > 30 days prior to study entry VLU is full thickness The subject is willing and able to give informed consent Exclusion Criteria: Decrease or increase in the ulcer surface area by more than 40% during the 14 day run-in period More than 75% of the VLU is on or below the malleolus Presence of a non-study ulcer within 1.5 cm of the VLU A VLU which shows signs of clinical infection or has cellulitis The VLU wound bed has exposed bone, tendon or fascia BMI > 45.0 kg/m2 Subject is not ambulatory Subjects who have a past or present disease that, which as judged by the Investigator, may affect the safety of the subject or the outcome of the study Cancerous cells in the VLU HbA1c >10% Blood biochemistry >3x upper limit of normal Heart failure NYHA class III or IV Subjects on renal replacement therapy Immunocompromized subjects

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nexagon® High Dose<br>Weekly applications of Nexagon® high dose in addition to compression dressings. | Drug: Nexagon® High Dose<br>* Weekly, topical application of Nexagon® high dose used with compression dressings.<br>|
| Placebo Comparator: Nexagon® Vehicle<br>Weekly applications of Nexagon® Vehicle in addition to compression dressings. | Drug: Nexagon® Vehicle<br>* Weekly, topical application of Nexagon® Vehicle used with compression dressings.<br>|
| No Intervention: No Investigational Product<br>Weekly application of compression dressings. | |
| Experimental: Nexagon® Low Dose<br>Weekly applications of Nexagon® low dose in addition to compression dressings. | Drug: Nexagon® Low Dose<br>* Weekly, topical application of Nexagon® low dose used with compression dressings.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surface area reduction |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complete closure |  | 10 weeks | 
| Time to complete closure |  | 10 weeks | 
| Incidence of ulcer recurrence |  | 12 weeks post closure | 
| Pain |  | 10 weeks | 
| Incidence of adverse events |  | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VLU, Venous Leg Ulcers, Ulcers, chronic wounds, wounds, Nexagon, CoDa