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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 - same dose 6 wks

Nitric Oxide modified treatment

About this trial

This is an interventional treatment trial for Venous Ulcers focused on measuring Nitric Oxide, Venous Leg Ulcers

Eligibility Criteria

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

Sites / Locations

Retreat Hospital, Wound Healing Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

A - Standard of Care (control)

B Same treatment for 6 weeks

C - modified treatment, 5 wks lower dose

Arm Description

Standard of care - dressings and sustained compression only

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

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

Outcomes

Primary Outcome Measures

Wound Healing

% Re-epithelialization

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00545298

First Posted

October 16, 2007

Last Updated

October 18, 2012

Sponsor

Nitric BioTherapeutics, Inc

1. Study Identification

Unique Protocol Identification Number

NCT00545298

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Terminated

Why Stopped

Strategic direction of the sponsor changed

Study Start Date

October 2007 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

November 2008 (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

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.

6. Conditions and Keywords

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

Venous Ulcers

Keywords

Nitric Oxide, Venous Leg Ulcers

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

4 (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

Arm Title

B Same treatment for 6 weeks

Arm Type

Experimental

Arm Description

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

Arm Title

C - modified treatment, 5 wks lower dose

Arm Type

Experimental

Arm 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

Intervention Type

Drug

Intervention Name(s)

Nitric Oxide - same dose 6 wks

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Nitric Oxide modified treatment

Intervention Description

200ppm, 8hrs/day for 1 week, followed by 25ppm 8hrs/day for 5 weeks Gas is delivered to a patch over the wound

Primary Outcome Measure Information:

Title

Wound Healing

Description

% Re-epithelialization

Time Frame

Week 20

Title

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

Description

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

Time Frame

up to 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph V Boykin, MD

Organizational Affiliation

HCA Retreat Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Retreat Hospital, Wound Healing Center

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23220

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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