Condition(s) treated: Venous Ulcers

Intervention: Nitric Oxide (Drug); Nitric Oxide (Drug)

Phase: Phase 2

Enrollment status: Recruiting

Sponsor: Nitric BioTherapeutics, Inc

Principal investigator(s) or official(s):
Joseph V Boykin, MD, Principal Investigator, Affiliation: HCA Retreat Hospital

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

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

Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Measurement of endogenous nitric oxide bioactivity (Time Frame: Baseline, weeks 1, 3,6, 12 and 20)

Detailed 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.

Minimum eligible age: 18 Years. Eligible gender(s): Both.

Criteria:

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.

Retreat Hospital, Wound Healing Center, Richmond, Virginia 23220, United States; Recruiting
Janine Young, RN, Phone: 804-254-5199, Email: Janine.Young@HCAhealthcare.com

Start date: October 2007
End date: September 2008
Last updated: April 25, 2008

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