Topical Wound Oxygen vs. Compression Therapy in the Management of Refractory, Non-Healing Venous Leg Ulcers; A prospective Randomised Controlled Trial

Conditions: Chronic, refarctory, non-healing venous ulcers with a duration of more than two years.
MedDRA version: 9.1Level: LLTClassification code 10047260Term: Venous ulceration

Registration Number: EUCTR2007-004831-47-IE

Lead Sponsor: inde Gas Therapeutics

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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
screening
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
F.1.3.1 Number of subjects for this age range

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
11.Pseudomonas infection
12. Presence of gangrene
13. Deep venous thrombosis (DVT) present
14. Connetive tissue disease present
15. Presence of any illness that could limit long-term compliance (e.g. epilepsy)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this trial is to evaluate the safety and efficacy of topical wound oxygen in managing refractory venous ulcers, at both the clinical and molecular levels.;Primary end point(s): The primary endpoint is the proportion of index ulcers fully healed after 12 weeks of therapy.;Secondary Objective: The secondary objectives are to compare the outcome of TWO to that of compression dressings in terms of:<br>1. proportion of fully healed ulcers<br>2. The time required for compete ulcer closure or time to skin grafting<br>3. The change in ulcers surface area<br>4. The degree of beacterial elimination<br>5. Changes in quality of life<br>6. The dgree of pain reduction<br>7. Ulcer recurrance rate<br>8. The up-regulation of angiogenesis related growth factors

Secondary Outcome Measures