Educational Interventions in Venous Leg Ulcer

NCT07031180 | Not Yet Recruiting

• 1 other identifier: VLU-2024-01
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Venous ulcers are skin lesions caused by impaired blood circulation. In Western countries, about 1% of the population is affected, and approximately 3% those over 80 years old. Venous leg ulcers tend to become chronic; a lesion is defined as chronic when it does not progress towards spontaneous healing. The treatment of these lesions inevitably involves long healing times, which results in increased healthcare costs. Moreover, venous leg ulcers have recurrence rates ranging from 18% to 28%. For this reason, it is important to support patients affected by or at risk of venous ulcers during their healing process or for prevention. Objectives: The primary objective of the study is to assess the superiority of the educational interventions to the standard therapeutic education, in improving the patient's/caregiver's self-efficacy, after 4 weeks, 3, 6 and 12 months from the educational intervention begin. The secondary objectives are to clinically assess the impact of the educational intervention in decreasing healing time and recurrence rates and in patients' well-being after 12 months of follow-up. Additionally, the Well-being of Wounds Inventory (WOW-I) questionnaire will be validated in its Italian version. Methods: the study is a two arm moncentric randomized-controlled trial. The participants will be randomly assigned into two groups. The control group will receive an educational intervention through a pamphlet, which represents the standard education received in the outpatient clinics involved in the study. The intervention group instead will receive an experimental educational intervention through video played specifically for this study. The socio-demografic, health and ulcer related factors will be collected and the questionnaires: venous leg ulcer knowledge (VLUK), Venous Leg Ulcer Self-Efficacy Tool (VeLUSET) and Well-being Of Wounds Inventory (WOW I) will be administered to the patients during the outpatient clinic visit, before the treatment and after 4 weeks, 3 and 6 months after the intervention. The study also includes a telephonic follow up at 12 months from the start carried out to assess if the patient's venous ulcer has healed or recurred.

Conditions

Venous Leg Ulcers

Keywords

venous leg ulcer; education; randomized controlled trial; knowledge; self-care skills

Outcome Measures

Primary Outcomes (2)

• The level of patient's knowledge

  A primary outcome of this study is the change of the level of patient's knowledge about him/her disease. This outcome will assess by the administration pre and post the educational intervention of the "Venous Leg Ulcer Knowledge (VLUK)" questionnaire in its Italian version, that comprises 15 multiple-choice questions. The tool has a minimum score of 0 and a maximum of 15 where higher scores mean a better knowledge about VLU.

  From enrollment to the end of treatment at 6 months

• The level of patient's self-care ability

  A primary outcome of this study is the change of the level of patient's self-care ability in the management of him/her disease. This outcome will assess by the administration, pre and post the educational intervention, of the "Venous Leg Ulcer Self Efficacy Tool (VeLUSET)". The tool comprises 30 itemswith a score from zero to ten (minimum score 0, maximum score 300), higer scores indicate more elevated perception of self-care ability.

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (3)

• VLU recurrence

  12 months after enrolment

• healing time

  From enrollment to the end of treatment at 6 months

• The well-being

  From enrollment to the end of treatment at 6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

The video recordings will be made available to patients randomized to the experimental/intervention group by providing a QR code linked to the Youtube or other similar platform in order to be played by a digital device already available to patients and caregivers. It will be played for the first time at the end of the first study visit after all assessments have been completed. Patients and caregivers will be encouraged to play the video recordings as they need and prefer.

Other: educational video

Control group

ACTIVE COMPARATOR

The control group will not receive the additional educational video but will receive the standard of care and an educational pamphlet.

Other: educational pamphlet (standard educational intervention)

Interventions

educational video OTHER

The experimental educational intervention will consist of professional video recordings that will cover the following topics: 1. Disease knowledge (VLU) 2. Medication management 3. The importance of compression therapy 4. Diet and physical activity The video recordings' contents will result from a review of the literature and guidelines, which will be later reviewed by a panel of experts in VLU. The video will be recorded by experienced video-maker and by a group of volunteers who will be the actors.

Intervention group

educational pamphlet (standard educational intervention) OTHER

The educational brochure is an educational intervention already in use at the setting involved in the study.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• older than 18 years;
• with venous leg ulcer;
• who understand Italian language;
• who is able to read and understand the questions;
• who attending to the nursing clinics involved in the study;
• who have given consent to participate in the study;
• who use a smart device with an internet connection or with caregiver able to provide the smart device as video player.

You may not qualify if:

• with cognitive impairment;
• who have an ankle-arm index/Winsor's index (ABI) less than 0.90. / with arterial insufficiency
• patients with arterial or mixed-origin ulcers

Sponsors & Collaborators

• University of Padova: lead
• Azienda Ulss 6 Euganea: collaborator

Study Sites (1)

Azienda ULSS 6 Euganea

Padua, PD, 35131, Italy

Location

Related Publications (14)

• Balestroni G, Bertolotti G. [EuroQol-5D (EQ-5D): an instrument for measuring quality of life]. Monaldi Arch Chest Dis. 2012 Sep;78(3):155-9. doi: 10.4081/monaldi.2012.121. Italian.

  PMID: 23614330 BACKGROUND

• Baquerizo Nole KL, Yim E, Van Driessche F, Lamel SA, Richmond NA, Braun LR, Kirsner RS. Educational interventions in venous leg ulcer patients. Wound Repair Regen. 2015 Jan-Feb;23(1):137-40. doi: 10.1111/wrr.12247. Epub 2015 Feb 13. No abstract available.

  PMID: 25487073 BACKGROUND

• Bobbink P, Pugliese MT, Larkin P, Probst S. Nurse-led patient education for persons suffering from a venous leg ulcer in outpatient's clinics and homecare settings: A scoping review. J Tissue Viability. 2020 Nov;29(4):297-309. doi: 10.1016/j.jtv.2020.08.006. Epub 2020 Aug 29.

  PMID: 32907753 BACKGROUND

• Brown A. Evaluating the reasons underlying treatment nonadherence in VLU patients: introducing the VeLUSET Part 1 of 2. J Wound Care. 2014 Jan;23(1):37, 40, 42-4, passim. doi: 10.12968/jowc.2014.23.1.37.

  PMID: 24406542 BACKGROUND

• Carradice D. Superficial venous insufficiency from the infernal to the endothermal. Ann R Coll Surg Engl. 2014 Jan;96(1):5-10. doi: 10.1308/003588414X13824511650498.

  PMID: 24417822 BACKGROUND

• Huang Y, Hu J, Xie T, Jiang Z, Ding W, Mao B, Hou L. Effects of home-based chronic wound care training for patients and caregivers: A systematic review. Int Wound J. 2023 Nov;20(9):3802-3820. doi: 10.1111/iwj.14219. Epub 2023 Jun 5.

  PMID: 37277908 BACKGROUND

• Kapp S, Miller C. The experience of self-management following venous leg ulcer healing. J Clin Nurs. 2015 May;24(9-10):1300-9. doi: 10.1111/jocn.12730. Epub 2014 Nov 24.

  PMID: 25422075 BACKGROUND

• Martinato M, Ranzato C, Faggian E, Foletto M, Moreal C, Guidone N, Acar AS, Masiero F, Beghin F, Peruzzo S, Gregori D, Comoretto RI. Knowledge assessment among subjects with chronic venous leg ulcer in outpatient setting: Translation and adaptation of a tool to identify subjects at risk of poor understanding. Wound Repair Regen. 2023 Sep-Oct;31(5):679-687. doi: 10.1111/wrr.13107. Epub 2023 Jul 17.

  PMID: 37368793 BACKGROUND

• O'Brien JA, Finlayson KJ, Kerr G, Edwards HE. Testing the effectiveness of a self-efficacy based exercise intervention for adults with venous leg ulcers: protocol of a randomised controlled trial. BMC Dermatol. 2014 Oct 3;14:16. doi: 10.1186/1471-5945-14-16.

  PMID: 25277416 BACKGROUND

• Price P, Harding K. Cardiff Wound Impact Schedule: the development of a condition-specific questionnaire to assess health-related quality of life in patients with chronic wounds of the lower limb. Int Wound J. 2004 Apr;1(1):10-7. doi: 10.1111/j.1742-481x.2004.00007.x.

  PMID: 16722893 BACKGROUND

• Protz K, Dissemond J, Seifert M, Hintner M, Temme B, Verheyen-Cronau I, Augustin M, Otten M. Education in people with venous leg ulcers based on a brochure about compression therapy: A quasi-randomised controlled trial. Int Wound J. 2019 Dec;16(6):1252-1262. doi: 10.1111/iwj.13172. Epub 2019 Aug 16.

  PMID: 31418532 BACKGROUND

• Raffetto JD, Ligi D, Maniscalco R, Khalil RA, Mannello F. Why Venous Leg Ulcers Have Difficulty Healing: Overview on Pathophysiology, Clinical Consequences, and Treatment. J Clin Med. 2020 Dec 24;10(1):29. doi: 10.3390/jcm10010029.

  PMID: 33374372 BACKGROUND

• Weller CD, Buchbinder R, Johnston RV. Interventions for helping people adhere to compression treatments for venous leg ulceration. Cochrane Database Syst Rev. 2016 Mar 2;3(3):CD008378. doi: 10.1002/14651858.CD008378.pub3.

  PMID: 26932818 BACKGROUND

• Zulec M, Rotar Pavlic D, Zulec A. The Effect of an Educational Intervention on Self-Care in Patients with Venous Leg Ulcers-A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Apr 12;19(8):4657. doi: 10.3390/ijerph19084657.

  PMID: 35457524 BACKGROUND

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Matteo Martinato, RN, PhD

CONTACT

+393472306806; matteo.martinato@ubep.unipd.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: September 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

IT (1)