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

NCT00545298 | Terminated Phase 2 Results DMC

• 1 other identifier: CTP 1
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Venous Ulcers

Keywords

Nitric Oxide; Venous Leg Ulcers

Outcome Measures

Primary Outcomes (2)

• Wound Healing

  % Re-epithelialization

  Week 20

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

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

  up to 24 weeks

Study Arms (3)

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

Drug: Nitric Oxide - same dose 6 wks

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

Drug: Nitric Oxide modified treatment

Interventions

Nitric Oxide - same dose 6 wks DRUG

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

B Same treatment for 6 weeks

Nitric Oxide modified treatment DRUG

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

C - modified treatment, 5 wks lower dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have a venous stasis ulcer between the knee and the ankle.
• Ulcer duration must be 60 days or greater

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nitric BioTherapeutics, Inc: lead

Study Sites (1)

Retreat Hospital, Wound Healing Center

Richmond, Virginia, 23220, United States

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Early termination due to small number of subjects enrolled

Results Point of Contact

• Title: Frank J. McCaney, CEO Sponsor
• Organization: Nitric BioTherapeutics Inc

fmccaney@nbtherapeutics.com

215-788-6200

Study Officials

• Joseph V Boykin, MD

  HCA Retreat Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2007
• First Posted: October 17, 2007
• Study Start: October 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: November 19, 2012
• Results First Posted: November 19, 2012

Record last verified: 2012-10

Locations

US (1)