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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CoDa Therapeutics Inc.; OcuNexus Therapeutics, Inc.

Criteria

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