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

Primary Purpose

Venous Ulcers

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Nitric Oxide 200ppm Group B

About this trial

This is an interventional treatment trial for Venous Ulcers focused on measuring venous, leg, ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Diabetic Foot & Wound Center
Alamo Podiatry Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

A - Standard of Care (control)

B Same treatment for 6 weeks, 200ppm NO gas

Arm Description

Standard of care - dressings and sustained compression only for the two week screening period and then for 20 weeks thereafter

Subjects were treated by topical application of 200ppm Nitric Oxide gas delivered to the wound area for 8 hours per day for 6 weeks

Outcomes

Primary Outcome Measures

Effect of daily application of Nitric Oxide on rate of closure in venous ulcers

Secondary Outcome Measures

Change in quality of life

Incidence of adverse events

Full Information

NCT ID

NCT00613808

First Posted

January 30, 2008

Last Updated

January 24, 2012

Sponsor

Nitric BioTherapeutics, Inc

1. Study Identification

Unique Protocol Identification Number

NCT00613808

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Terminated

Study Start Date

February 2008 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nitric BioTherapeutics, Inc

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Ulcers

Keywords

venous, leg, ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A - Standard of Care (control)

Arm Type

No Intervention

Arm Description

Standard of care - dressings and sustained compression only for the two week screening period and then for 20 weeks thereafter

Arm Title

B Same treatment for 6 weeks, 200ppm NO gas

Arm Type

Active Comparator

Arm Description

Subjects were treated by topical application of 200ppm Nitric Oxide gas delivered to the wound area for 8 hours per day for 6 weeks

Intervention Type

Drug

Intervention Name(s)

Nitric Oxide 200ppm Group B

Intervention Description

200 ppm, 8hrs / day for 6 weeks

Primary Outcome Measure Information:

Title

Effect of daily application of Nitric Oxide on rate of closure in venous ulcers

Time Frame

24 weeks or wound closure

Secondary Outcome Measure Information:

Title

Change in quality of life

Time Frame

24 weeks or wound closure

Title

Incidence of adverse events

Time Frame

24 weeks or wound closure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey Jensen, DPM

Organizational Affiliation

Private Practice, Denver, CO

Official's Role

Principal Investigator

Facility Information:

Facility Name

Diabetic Foot & Wound Center

City

Denver

State/Province

Colorado

ZIP/Postal Code

80220

Country

United States

Facility Name

Alamo Podiatry Associates

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78211

Country

United States

12. IPD Sharing Statement

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

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