A study to research if foam sclerotherapy of saphenous trunks can speed up the healing of chronic venous leg ulcers - foam sclerotherapy to treat leg ulcers

Phase 1

• Conditions: 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

• Registration Number: EUCTR2005-001551-38-GB
• Lead Sponsor: Gloucestershire Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-31
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 200

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
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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified