E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
We will include patients with insufficiency of the long and/or short saphenous vein as underlying cause of their venous leg ulcer. These patients may or may not have visible varicose veins of the long and/or short saphenous vein.
According to ICD classification: Chronic venous hypertension with ulcer ICD-9-CM-459.31 Chronic ulcer of the skin ICD-9-CM-707 |
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MedDRA Classification |
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 |
The aims of the study are to determine:
- the effect of foam sclerotherapy on the incompetent venous trunks - the effect of foam sclerotherapy in addition to compression therapy on ulcer healing
Set up a prospective, randomized, controlled trial |
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E.2.2 | Secondary objectives of the trial |
- the feasibility of performing foam sclerotherapy in patients with damaged, ulcerated skin in an outpatients setting - the assessment of the cost of foam sclerotherapy treatment - quality of life of the patient before and after their treatment
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- strict venous leg ulcer - ulcer > 4 weeks old - active ulcer CEAP classification C6 - full assessment: - venous duplex scanning - arterial doppler with ABPI > 0.85 - multilayer compression bandages are well tolerated - written informed consent |
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E.4 | Principal exclusion criteria |
- mixed arterial and venous ulcers - healed ulcers CEAP classification C5 - any history of thrombo-embolic disease - patients currently under oral anticoagulation therapy - total deep venous reflux - known allergy to liquid sclerosant - pregnancy or breast feeding - systemic disorders: rheumatoid arthritis and malignancies |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint will be the mean time to healing of the leg ulcer
Secondary endpoint includes the proportion of the ulcers healed at 12 and 24 weeks
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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 | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Information not present in EudraCT |
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 | No |
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 |
group A only compression bandages versus group B compression bandages and foam sclerotherapy |
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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 | Information not present in EudraCT |
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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Patients will be seen for the last time in trial 6 months after they started their therapy (group A compression therapy alone) (group B compression therapy and foam sclerotherapy). If the ulcer hasn't healed at 6 months they will be followed up for another 6 months. If at that stage the ulcer still hasn't healed they will be classified as "non-healers" in the study. After 1 year ne data will be collected anymore. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |