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

NCT ID: NCT00545298

Last Updated: 2012-11-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-11-30

Brief Summary

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

Detailed Description

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Prospective, single center. Controlled study of a moisture retentive wound dressing and sustained compression with 6 weeks of 8 hour daily nitric oxide treatments.

Conditions

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Venous Ulcers

Keywords

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Nitric Oxide Venous Leg Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A - Standard of Care (control)

Standard of care - dressings and sustained compression only

Group Type NO_INTERVENTION

No interventions assigned to this group

B Same treatment for 6 weeks

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

Group Type EXPERIMENTAL

Nitric Oxide - same dose 6 wks

Intervention Type DRUG

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

C - modified treatment, 5 wks lower dose

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

Group Type EXPERIMENTAL

Nitric Oxide modified treatment

Intervention Type DRUG

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

Interventions

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Nitric Oxide - same dose 6 wks

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nitric BioTherapeutics, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph V Boykin, MD

Role: PRINCIPAL_INVESTIGATOR

HCA Retreat Hospital

Locations

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Retreat Hospital, Wound Healing Center

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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CTP 1

Identifier Type: -

Identifier Source: org_study_id