Conditions: Venous Ulcers
Keywords: Nitric Oxide Venous Leg Ulcers
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 4
Healthy volunteers: no

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

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.

Arms:
arm 1: Standard of care - dressings and sustained compression only arm 2: 200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound arm 3: 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

Interventions: intervention 1: Nitric Oxide - same dose 6 wks intervention 2: Nitric Oxide modified treatment
Intervention descriptions: intervention 1: 200ppm, 8hrs / day for 6 weeks NO gas in nitrogen delivered to a patch over the wound intervention 2: 200ppm, 8hrs/day for 1 week, followed by 25ppm 8hrs/day for 5 weeks Gas is delivered to a patch over the wound

Protocol document: