Foam sclerotherapy for venous leg ulcers

Randomized controlled trial of foam sclerotherapy for venous leg ulcers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18090073

Enrollment

130

Registered

2022-04-25

Start date

2022-01-15

Completion date

Unknown

Last updated

2025-04-21

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

Conditions

Venous leg ulcers Circulatory System

Interventions

An electronic random number generator application is used for randomization. Eligible patients presenting with open venous leg ulcers who show evidence of underlying venous pathology on duplex scan wi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with active venous leg ulceration, classified as C6 in the CEAP classification 2. Have duplex or venography criteria of primary superficial venous reflux, or criteria of post-thrombotic deep venous reflux and/or obstruction 3. Show a refluxing network of veins in the vicinity of the ulcer; “ulcer veins”, and/or pathologic incompetent perforators

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating females 2. Age 2 years duration 6. VLU size >20 cm in any dimension 7. Participant unable to give informed consent

Design outcomes

Primary

Measure	Time frame
1. Time to complete venous leg ulcer healing measured by photography at weekly time intervals after the application of the treatment until healing	—

Secondary

Measure	Time frame
1. Venous leg ulcer healing measured by Lesionmeter software and photography at weekly intervals after the application of treatment until complete ulcer healing 2. Ulcer recurrence assessed by telephone follow up at monthly intervals after complete venous leg ulcer healing for a minimum of 6 months, and a maximum of 12 months 3. Ulcer-free time assessed by telephone follow up at monthly intervals after complete venous leg ulcer healing for a minimum of 6 months and a maximum of 12 months 4. Health-related quality of life assessed using the SF12 questionnaire before the start of treatment and at complete ulcer healing 5. Side effects of foam sclerotherapy assessed by patient history and physical examination during the follow-up visit in the week following the application of treatment 6. Outcome measured using the Venous Clinical Severity Score (VCSS) once before entering into the study, and once after complete ulcer healing, or at the end of the trial	—

Measure

Time frame

1. Venous leg ulcer healing measured by Lesionmeter software and photography at weekly intervals after the application of treatment until complete ulcer healing 2. Ulcer recurrence assessed by telephone follow up at monthly intervals after complete venous leg ulcer healing for a minimum of 6 months, and a maximum of 12 months 3. Ulcer-free time assessed by telephone follow up at monthly intervals after complete venous leg ulcer healing for a minimum of 6 months and a maximum of 12 months 4. Health-related quality of life assessed using the SF12 questionnaire before the start of treatment and at complete ulcer healing 5. Side effects of foam sclerotherapy assessed by patient history and physical examination during the follow-up visit in the week following the application of treatment 6. Outcome measured using the Venous Clinical Severity Score (VCSS) once before entering into the study, and once after complete ulcer healing, or at the end of the trial

—

Countries

Egypt

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026