EUCTR2007-004831-47-IE
Active, not recruiting
Not Applicable
Topical Wound Oxygen vs. Compression Therapy in the Management of Refractory, Non-Healing Venous Leg Ulcers; A prospective Randomised Controlled Trial
inde Gas Therapeutics0 sitesSeptember 6, 2007
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic, refarctory, non-healing venous ulcers with a duration of more than two years.
- Sponsor
- inde Gas Therapeutics
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Aged 18 years or more
- •2\. Written informed consent
- •3\. Venous ulcers present, with durationof more than two years
- •4\. No sign of improvement or healing of the relevant ulcer over past year prior to
- •5\. A C6 grading in the CEAP classification
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •1\. Pregnant \& lactating women
- •2\. Involvment in another clinical trial in the previos six months
- •3\. Legal incapacity
- •4\. Pateint is bed\-ridden
- •5\. Ischaemic ulcer/s present
- •6\. Diabetic ulcer/s present
- •7\. refusal to refrain from smoking
- •8\. Malignant ulceration/s
- •9\. Ulcer exposing bone or tendon
- •10\. Osteomyelitis
Outcomes
Primary Outcomes
Not specified
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