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

Nitric BioTherapeutics

Status and phase: Terminated; Phase 2

Conditions: Venous Ulcers

Treatments: Drug: Nitric Oxide - same dose 6 wks; Drug: Nitric Oxide modified treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT00545298

CTP 1

Details and patient eligibility

About

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

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 3 patient groups

A - Standard of Care (control)

No Intervention group

Description:

Standard of care - dressings and sustained compression only

B Same treatment for 6 weeks

Experimental group

Description:

200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound

Treatment:

Drug: Nitric Oxide - same dose 6 wks

C - modified treatment, 5 wks lower dose

Experimental group

Description:

200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound

Treatment:

Drug: Nitric Oxide modified treatment