Trial | NCT00545298  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Intervention/Treatment

    nitric oxide ...

  • Study Participants

    4
This study will test the safety and efficacy of nitric oxide gas in the treatment of venous leg ulcers
Prospective, single center. Controlled study of a moisture retentive wound dressing and sustained compression with 6 weeks of 8 hour daily nitric oxide treatments.
Study Started
Oct 31
2007
Primary Completion
Nov 30
2008
Study Completion
Nov 30
2008
Results Posted
Nov 19
2012
Estimate
Last Update
Nov 19
2012
Estimate

Drug Nitric Oxide - same dose 6 wks

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

Drug 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

A - Standard of Care (control) No Intervention

Standard of care - dressings and sustained compression only

B Same treatment for 6 weeks Experimental

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

C - modified treatment, 5 wks lower dose Experimental

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

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.

Summary

A - Standard of Care (Control)

B Same Treatment for 6 Weeks

C - Modified Treatment, 5 Wks Lower Dose

All Events

Event Type Organ System Event Term A - Standard of Care (Control) B Same Treatment for 6 Weeks C - Modified Treatment, 5 Wks Lower Dose

Wound Healing

% Re-epithelialization

B - Same Treatment for 6 Weeks

10.0
% re-epithelialization

A - Standard of Care (Control)

C - Modified Treatment, 5 Wks Lower Dose

Adverse Events (AEs) and Serious Adverse Events (SAEs)

All reported adverse events, related or unrelated to the study drug.

A - Standard of Care (Control)

AEs

4.0
number of events

SAEs

B - Same Treatment for 6 Weeks

AEs

4.0
number of events

SAEs

C - Modified Treatment, 5 Wks Lower Dose

AEs

7.0
number of events

SAEs

Total

4
Participants

Age Continuous

69
years (Mean)
Standard Deviation: 5

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

A - Standard of Care (Control)

B - Same Treatment for 6 Weeks

C - Modified Treatment, 5 Wks Lower Dose

Drop/Withdrawal Reasons

A - Standard of Care (Control)

C - Modified Treatment, 5 Wks Lower Dose