Foam sclerotherapy for venous leg ulcers
| ISRCTN | ISRCTN18090073 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18090073 |
| Secondary identifying numbers | RCT2022-1 |
- Submission date
- 13/04/2022
- Registration date
- 25/04/2022
- Last edited
- 11/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Venous leg ulcers are the commonest type of ulcers affecting the legs. They are caused by obstruction of the veins as a result of previous thrombosis (blood clot), or by reflux of the venous valves (reversal of blood flow), which may be either present from birth or caused by previous thrombosis. In addition to the standard care of venous leg ulcers which includes wound care, treatment of the underlying venous pathology (disease), and appropriate compression therapy, foam sclerotherapy of the refluxing veins around the ulcers has been used for more than 10 years by many physicians, who reported improved outcomes in terms of time to achieve complete ulcer healing. The aim of this study is to compare standard treatment versus standard treatment in addition to foam sclerotherapy of the refluxing veins in the vicinity of the ulcer.
Who can participate?
Patients with open venous leg ulcers with underlying venous pathology and refluxing veins near the ulcer
What does the study involve?
Participants are randomly allocated into two groups. One group will receive standard treatment only, while the other group will receive foam sclerotherapy of the veins around the ulcer in addition to standard treatment. The foam sclerotherapy treatment is applied once and could be repeated one more time if necessary.
What are the possible benefits and risks of participating?
Participants will be treated by experts in the field and will receive the standard care for venous leg ulcers. Those who are in the foam sclerotherapy group may benefit from more rapid healing of the ulcers. The risks are minimal and include the potential side effects of foam sclerotherapy.
Where is the study run from?
The study is performed in outpatient service facilities in multiple centers in Egypt.
When is the study starting and how long is it expected to run for?
September 2021 to December 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Rashad Bishara
rashadbishara@gmail.com
Contact information
Principal Investigator
1123 Kornish El Nile
Maspero
Cairo
11221
Egypt
 ORCID ID |
0000-0002-5645-5093 |
|---|---|
| Phone | +20 (0)1222178355 |
| rashadbishara@gmail.com |
Study information
| Study design | Multicenter prospective randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Written in Arabic (local language) |
| Scientific title | Randomized controlled trial of foam sclerotherapy for venous leg ulcers |
| Study acronym | FoVLU |
| Study objectives | Foam sclerotherapy of refluxing veins in the vicinity of the venous leg ulcer promotes healing and reduces the time to complete ulcer healing. |
| Ethics approval(s) | Approved 09/02/2022, Ethical Committee of the General Organization of Teaching Hospitals (GOTHI; Dr Nagham Al-Amir, 16 Kasr Al-Aini Street, Sayeda Zeinab, Cairo 11617, Egypt; +20 (0)1005181311; dr_alamir@hotmail.com), ref: IDE00274 |
| Health condition(s) or problem(s) studied | Venous leg ulcers |
| Intervention | 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 will be randomized into two groups: Group A will be treated by foam sclerotherapy of the refluxing venous plexus in the vicinity of the ulcer, in addition to standard care for venous leg ulcers. The treatment is applied once and could be repeated one more time if necessary. Group B will receive standard care for venous leg ulcers only. Standard care for venous leg ulcers may include, ablation or stripping of superficial venous reflux, phlebotomy or foam sclerotherapy of incompetent tributaries, recanalization and stenting of occluded iliac veins, wound care, and appropriate compression therapy. Every patient will be treated until the ulcer heals or until the end of the trial. The duration of follow up is a minimum of 6 months, up to 12 months. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Time to complete venous leg ulcer healing measured by photography at weekly time intervals after the application of the treatment until healing |
| Secondary outcome measures | 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 |
| Overall study start date | 01/09/2021 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 130 |
| Total final enrolment | 77 |
| Key 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 |
| Key exclusion criteria | 1. Pregnant and lactating females 2. Age <18 years 3. Peripheral arterial disease confirmed by ABPI <0.8, or a duplex scan showing significant peripheral arterial disease 4. Do not show evidence of a refluxing network of veins in the vicinity of the ulcer; “ulcer veins” 5. VLU >2 years duration 6. VLU size >20 cm in any dimension 7. Participant unable to give informed consent |
| Date of first enrolment | 15/01/2022 |
| Date of final enrolment | 30/12/2023 |
Locations
Countries of recruitment
- Egypt
Study participating centres
11221
Egypt
11221
Egypt
21519
Egypt
44519
Egypt
11517
Egypt
11562
Egypt
11757
Egypt
Sponsor information
Government
16 A, Qasr Al-Agni, Sayeda Zeinab
Cairo
11617
Egypt
| Phone | +20 (0)23648073 |
|---|---|
| info@gothi.gov.eg | |
| Website | https://gothi.gov.eg |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in high-impact peer-reviewed journals |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 20/04/2022 | No | No | ||
| Protocol file | 17/10/2022 | No | No | ||
| Results article | 08/04/2025 | 11/04/2025 | Yes | No |
Additional files
Editorial Notes
11/04/2025: Publication reference added.
07/06/2024: Total final enrolment added.
05/06/2024: The following changes were made to the study record:
1. The overall study end date was changed from 30/06/2024 to 31/12/2024.
2. The intention to publish date was changed from 30/12/2024 to 30/06/2025.
06/12/2023: The study dates were confirmed.
25/08/2023: The intention to publish date was changed from 31/12/2023 to 30/12/2024.
24/08/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 30/06/2023 to 30/12/2023.
2. The overall study end date was changed from 30/12/2023 to 30/06/2024.
17/10/2022: Uploaded protocol (not peer reviewed)
20/04/2022: Trial's existence confirmed by the Ethical Committee of the General Organization of Teaching Hospitals (GOTHI).
