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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001551-38-GB

Enrollment

200

Registered

2005-08-31

Start date

2005-09-29

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Fibro-Vein STD Pharmaceutical Products LTD Fields Yard Plough Lane Hereford England HR4 0EL

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 ; Main Objective: 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 ; Secondary Objective: - 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	—

Measure

Time frame

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 ; Main Objective: 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 ; Secondary Objective: - 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

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026