NCT02364921

Brief Summary

The purpose of this study is to evaluate the effectiveness of a multilayer compression bandage (two layers), compared with the crepe bandage, on healing of venous leg ulcers, in patients attended in nursing Primary Care Health Centres, at 12 weeks follow-up.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

September 10, 2018

Status Verified

September 1, 2018

Enrollment Period

3.7 years

First QC Date

February 5, 2015

Last Update Submit

September 7, 2018

Conditions

Venous Ulcers

Keywords

venous ulcerwound healingcompression bandages

Outcome Measures

Primary Outcomes (1)

  • degree of scarring achieved measured by Resverch 2.0

    degree of scarring achieved measured by the questionnaire Resverch 2.0

    twelve weeks

Secondary Outcomes (1)

  • Quality of Life measured by Charing Cross Venous Ulcer Questionnaire (CCVUQ-e)

    twelve weeks

Study Arms (2)

Two-layer compression bandage

EXPERIMENTAL

Two multilayer compression bandage: Usual clinical practice in venous ulcer in wound care in assessing, cleaning, desinfection, debridement and topical treatment.Measure the ankle circumference and choose the correct kit accordingly (ankle size 18-25cm or 25-32cm). Apply one to seven days

Device: Two multilayer compression bandage

crepe bandage

ACTIVE COMPARATOR

Crepe bandage: Usual clinical practice in venous ulcer in wound care. crepe bandage apply one to seven days

Device: Crepe bandage

Interventions

Two multilayer compression bandageDEVICE

Usual clinical practice in venous ulcer in wound care in assessing, cleaning, desinfection, debridement and topical treatment. Compression therapy: a multilayer compression bandage with two layers, suitable for the treatment of venous leg ulcers and to reduce edema chronic venous be used. Apply one two seven days

Also known as: K2 Urgo
Two-layer compression bandage
Crepe bandageDEVICE

Crepe bandage: Usual clinical practice in venous ulcer in wound care. crepe bandage apply one to seven days

crepe bandage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People With a diagnosis of chronic venous ulcer over six weeks duration.
  • Presence of a larger Ankle Arm index (ABI) of 0.8 and less than 1.3.
  • People Able to follow the trial own demands, able to understand the questionnaires, with no intention of moving and localizable for the duration of the study.
  • That give written informed consent to participate

You may not qualify if:

  • Patients diagnosed with poorly controlled diabetes mellitus (last HbA1c greater than 7).
  • In Antineoplastic therapy.
  • Decompensated heart -insufficience .
  • Dermatitis acute phase, at the time of the study.
  • Rheumatoid-arthritis.
  • Thrombosis Venosa (DVT) in acute phase.
  • Patients with mixed ulcers
  • Patients who participate simultaneously in another clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carmen Folguera

Madrid, 28030, Spain

Location

Related Publications (1)

  • Folguera-Alvarez C, Garrido-Elustondo S, Verdu-Soriano J, Garcia-Garcia-Alcala D, Sanchez-Hernandez M, Torres-de Castro OG, Barcelo-Fidalgo ML, Martinez-Gonzalez O, Ardiaca-Burgues L, Solano-Villarrubia C, Lebracon-Cortes PR, Molins-Santos C, Fresno-Flores M, Canovas-Lago MC, Benito-Herranz LF, Garcia-Sanchez MT, Castillo-Pla O, Morcillo-San Juan MS, Ayuso-de la Torre MB, Burgos-Quintana P, Lopez-Torres-Escudero A, Ballesteros-Garcia G, Garcia-Cabeza P, de Francisco-Casado MA, Rico-Blazquez M; ECAMulticapa Group. ECAMulticapa: Effectiveness of double-layered compression therapy for healing venous ulcers in primary care: a Study Protocol. BMC Nurs. 2016 Oct 12;15:58. doi: 10.1186/s12912-016-0179-x. eCollection 2016.

    PMID: 27752238DERIVED

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Maria del Carmen Folguera, Nurse

    Gerencia Atención Primaria, Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2015

First Posted

February 18, 2015

Study Start

June 1, 2014

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

September 10, 2018

Record last verified: 2018-09

Locations

ES(1)