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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01199588

Acronym

NOVEL2

Enrollment

300

Registered

2010-09-13

Start date

2011-05-31

Completion date

2013-03-31

Last updated

2014-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Leg Ulcers

Keywords

VLU, Venous Leg Ulcers, Ulcers, chronic wounds, wounds, Nexagon, CoDa

Brief summary

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.

Interventions

DRUGNexagon® Low Dose

Weekly, topical application of Nexagon® low dose used with compression dressings.

DRUGNexagon® High Dose

Weekly, topical application of Nexagon® high dose used with compression dressings.

DRUGNexagon® Vehicle

Weekly, topical application of Nexagon® Vehicle used with compression dressings.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Diagnosis of venous leg ulceration supported by venous duplex ultrasonography demonstrating venous reflux \> 0.5 seconds 2. Ankle brachial index of \> 0.80 3. Venous Leg Ulcer (VLU) area greater than 2 cm2 and less than 20 cm2 4. Compliant with and able to tolerate high compression bandaging 5. VLU present for \> 30 days prior to study entry 6. VLU is full thickness 7. The subject is willing and able to give informed consent

Exclusion criteria

1. Decrease or increase in the ulcer surface area by more than 40% during the 14 day run-in period 2. More than 75% of the VLU is on or below the malleolus 3. Presence of a non-study ulcer within 1.5 cm of the VLU 4. A VLU which shows signs of clinical infection or has cellulitis 5. The VLU wound bed has exposed bone, tendon or fascia 6. BMI \> 45.0 kg/m2 7. Subject is not ambulatory 8. 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 9. Cancerous cells in the VLU 10. HbA1c \>10% 11. Blood biochemistry \>3x upper limit of normal 12. Heart failure NYHA class III or IV 13. Subjects on renal replacement therapy 14. Immunocompromized subjects

Design outcomes

Primary

Measure	Time frame
Surface area reduction	10 weeks

Secondary

Measure	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

Countries

Australia, New Zealand, South Africa, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026