E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative complications after vascular surgery in the leg. This includes wound infections, wound dehiscience and necrosis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057480 |
E.1.2 | Term | Hyperbaric oxygen therapy |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate whether postoperative HBO vs placebo will lead to a shorter time to healing of operative wounds. |
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E.2.2 | Secondary objectives of the trial |
To evaluate whether postoperative HBO vs placebo will: a) lead to an improvement in the proportion of healed operative wounds assed at 30 days. b) lead to reduction in postoperative wound infections in patients with diabetes undergoing infrainguinal bypass surgery. c) lead to a decrease in wound infection severity. d) lead to an increased peripheral tissue oxygenation measured with Transcutaneous PO2 e) lead to an improvement in quality of life measured with SF-36. f) lead to an improvement in amputation-free survival up to 1 year. g) lead to a reduction of total hospital stay.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients are eligible for inclusion if the following criteria are fulfilled 1. Informed consent obtained 2. Scheduled for lower extremity open vascular surgery 3. Diabetes treated with insulin or oral antidiabetic medicine 4. 18 years or older |
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E.4 | Principal exclusion criteria |
Patients having any of the following at randomization will not be included in the study 1. Contraindications to HBO therapy 2. Pregnancy 3. Patients already in HBO treatment 4. Creatinine > 250 mmol/L 5. NYHA class IV heart failure or severe cardiopulmonary disease with desaturation judged to be incompatible with safe HBO/ placebo therapy in a monoplace chamber 6. Malignancy or other serious medical condition where it is likely that the patient will significantly deteriorate or not survive within the two years of follow up. 7. Simultaneous or previous (within 30 days prior to study entry) participation in a clinical study using experimental drugs or devices. 8. Mental condition making the subject unable to understand the concepts and risk of the study
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E.5 End points |
E.5.1 | Primary end point(s) |
1) The primary outcome is healing of all operative wounds defined as complete epithelialisation and no need for wound dressings. This will be asseed by comparing time to complete healing between treatment groups. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
The placebo group will be treated with 21% oxygen (normal air) at slightly increased pressure |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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All patients randomized have undergone the one year final visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |