Safety and Efficacy of Gaseous Nitric Oxide on Venous Sta... | NCT00613808

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

NCT00613808

Sponsor

Nitric BioTherapeutics, Inc

Status

Terminated

Last Update Posted

Jan 25, 2012Estimated

Enrollment

6Actual

Phase

Phase 2

Conditions

Venous Ulcers

Interventions

Nitric Oxide 200ppm Group B

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Nov 2008Actual

Completion Date

May 2009Actual

First Submitted Date

Jan 30, 2008

First Submission Date that Met QC Criteria

Jan 30, 2008

First Posted Date

Feb 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2012

Last Update Posted Date

Jan 25, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether nitric oxide (NO)gas is effective in the treatment of venous ulcers of the lower leg.

Detailed Description

SUbjects were divided into two Groups - one receiving 200ppm NO gas delivered topically to the wound area for 8 hours a day for 6 weeks. The other Group (control arm) received Standard of Care (compression) for 22 weeks.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A - Standard of Care (control)	No Intervention	Standard of care - dressings and sustained compression only for the two week screening period and then for 20 weeks thereafter
B Same treatment for 6 weeks, 200ppm NO gas	Active Comparator	Subjects were treated by topical application of 200ppm Nitric Oxide gas delivered to the wound area for 8 hours per day for 6 weeks	Drug: Nitric Oxide 200ppm Group B

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nitric Oxide 200ppm Group B	Drug	200 ppm, 8hrs / day for 6 weeks	B Same treatment for 6 weeks, 200ppm NO gas

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect of daily application of Nitric Oxide on rate of closure in venous ulcers		24 weeks or wound closure

Secondary Outcomes

Measure	Description	Time Frame
Change in quality of life		24 weeks or wound closure
Incidence of adverse events		24 weeks or wound closure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must have given written informed consent and HIPAA authorization
Must be ≥ 18 years of age
Must have a venous ulcer for 60 days or greater
ABPI > 0.8 and ≤ 1.2
Must have ulcer between 3cm2 and 25cm2 in size

Exclusion Criteria:

Has an ulcer that is deemed by the Investigator to be caused primarily by a medical condition other than venous insufficiency
BMI ≥ 35
Has evidence of clinical infection
Suffers from diabetes mellitus with HbA1c ≥ 8%
Suffers from clinically significant arterial disease
Has a known allergy to any of the compounds / drugs that are part of this protocol
Has evidence of the ulcer and / or infection extending to the underlying muscle, tendon or bone
Has used any investigational drug(s) within 30 days preceding randomization
Is unable to manage self-treatment
Is pregnant, nursing mother or a woman of child bearing potential who is not using an adequate form of contraception (or abstinence)
Suffers from a condition which in the opinion of the Investigator would compromise the safety of the subject and / or the quality of the data
Is using any of the prohibited concomitant medications or treatments
Has previously participated in this study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Diabetic Foot & Wound Center		Denver	Colorado	80220	United States
Alamo Podiatry Associates

ID	Term
D014648	Varicose Veins
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D007871	Leg Ulcer