Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers

Venous Ulcers Clinical Trial

Official title:

An Investigation of the Topical Application of Gaseous Nitric Oxide on Safety and Efficacy in Venous Stasis Leg Ulcers of the Lower Extremities

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00545298
• Other study ID #: CTP 1
• Status: Terminated
• Phase: Phase 2
• First received: October 16, 2007
• Last updated: October 18, 2012
• Start date: October 2007
• Est. completion date: November 2008

Study information

• Verified date: October 2012
• Source: Nitric BioTherapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will test the safety and efficacy of nitric oxide gas in the treatment of venous leg ulcers

Description:

Prospective, single center. Controlled study of a moisture retentive wound dressing and sustained compression with 6 weeks of 8 hour daily nitric oxide treatments.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must have a venous stasis ulcer between the knee and the ankle.

• Ulcer duration must be 60 days or greater

Exclusion Criteria:

• Has an ulcer that is deemed by the Investigator to be caused primarily by a medical condition other than venous insufficiency

• Suffers from diabetes mellitus with HbA1c = 8%

• Suffers from clinically significant arterial disease

• Is pregnant, a nursing mother or a woman of child bearing potential who is not using an adequate form of contraception (or abstinent)

The above is a partial list of the inclusion and exclusion criteria; however, other inclusion and exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Ulcer
• Varicose Ulcer
• Venous Ulcers

Intervention

Drug:
• Nitric Oxide - same dose 6 wks
200ppm, 8hrs / day for 6 weeks NO gas in nitrogen delivered to a patch over the wound
• Nitric Oxide modified treatment
200ppm, 8hrs/day for 1 week, followed by 25ppm 8hrs/day for 5 weeks Gas is delivered to a patch over the wound

Locations

Country	Name	City	State
United States	Retreat Hospital, Wound Healing Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Nitric BioTherapeutics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Healing	% Re-epithelialization	Week 20	No
Primary	Adverse Events (AEs) and Serious Adverse Events (SAEs)	All reported adverse events, related or unrelated to the study drug.	up to 24 weeks	Yes