A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers (NOVEL2)

Ocunexus Therapeutics

Status and phase: Completed; Phase 2

Conditions: Venous Leg Ulcers

Treatments: Drug: Nexagon® Vehicle; Drug: Nexagon® Low Dose; Drug: Nexagon® High Dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01199588

NEX-ULC-007

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 4 patient groups, including a placebo group

Nexagon® High Dose

Experimental group

Description:

Weekly applications of Nexagon® high dose in addition to compression dressings.

Treatment:

Drug: Nexagon® High Dose

Nexagon® Vehicle

Placebo Comparator group

Description:

Weekly applications of Nexagon® Vehicle in addition to compression dressings.

Treatment:

Drug: Nexagon® Vehicle

No Investigational Product

No Intervention group

Description:

Weekly application of compression dressings.

Nexagon® Low Dose

Experimental group

Description:

Weekly applications of Nexagon® low dose in addition to compression dressings.

Treatment:

Drug: Nexagon® Low Dose