Expired Study
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San Antonio, Texas 78211


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00613808


Primary Contact:

Principal Investigator
Jeffrey Jensen, DPM
Private Practice, Denver, CO


Backup Contact:

N/A


Location Contact:

San Antonio, Texas 78211
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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