Chronic, refarctory, non-healing venous ulcers with a duration of more than two years. MedDRA version: 9.1 Level: LLT Classification code 10047260 Term: Venous ulceration
Conditions
Interventions
Trade Name: Medical Liquid Oxygen
Pharmaceutical Form: Inhalation gas
INN or Proposed INN: oxygen
Concentration unit: % (V/V) percent volume/volume
Concentration type: not less then
Concentration numb
Sponsors
Linde Gas Therapeutics
Eligibility
Sex/Gender
All
Inclusion 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 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: 1. proportion of fully healed ulcers 2. The time required for compete ulcer closure or time to skin grafting 3. The change in ulcers surface area 4. The degree of beacterial elimination 5. Changes in quality of life 6. The dgree of pain reduction 7. Ulcer recurrance rate 8. The up-regulation of angiogenesis related growth factors | — |
Countries
Ireland
Outcome results
None listed